FDA Legislation in the 110th Congress: A Side-by-Side Comparison of S. 1082 and H.R. 2900

FDA Legislation in the 110 Congress:
A Side-by-Side Comparison of
S. 1082 and H.R. 2900
Updated August 6, 2007
Erin D. Williams, Susan Thaul, Sarah A. Lister,
Donna V. Porter, and C. Stephen Redhead
Domestic Social Policy Division

FDA Legislation in the 110 Congress:
A Side-by-Side Comparison of S. 1082 and H.R. 2900
Both the House and the Senate have passed comprehensive legislation to
reauthorize existing Food and Drug Administration (FDA) programs and expand the
agency’s authority to ensure the safety of prescription drugs, medical devices, and
biologics. The Senate passed the Food and Drug Administration Revitalization Act
(S. 1082) on May 9, 2007. The House passed the Food and Drug Administration
Amendments Act of 2007 (H.R. 2900) on July 11, 2007.
At its core, the legislation renews authority for two key user fee programs that
are set to expire on October 1, 2007: the Prescription Drug User Fee Act (PDUFA;
P.L. 107-188) and the Medical Device User Fee and Modernization Act (MDUFMA;
P.L. 107-250). These account for 87% of FDA’s user fee revenue and 19% of FDA’s
total FY2008 program level budget. Without the reauthorizations, and absent a
substantial increase in FDA’s annual appropriations, the agency would lose a
significant source of funding. FDA had warned that a failure to reauthorize the user
fee programs before August 1, 2007, would require the agency to issue layoff notices,
but the agency has reportedly forestalled that necessity by switching to reserve funds.
In addition to user fee programs, the bills reauthorize two other FDA authorities
related to prescription drugs for pediatric populations, which are also set to expire on
October 1, 2007: the Best Pharmaceuticals for Children Act (BPCA; P.L. 107-109)
and the Pediatric Research Equity Act (PREA; P.L. 108-155). These laws provide
marketing exclusivity incentives and requirements for studying pediatric use of
on-patent and off-patent drugs. S. 1082 and H.R. 2900 also contain provisions
related to drug safety, pediatric medical devices, clinical trial registration, and the
creation of a new nonprofit entity to assist FDA with its mission. The bills’
overlapping provisions are similar, but not identical.
S. 1082 contains some additional provisions that are not present in H.R. 2900,
on the topics of food safety, prescription drug importation, and domestic pet turtle
market access. Attempts to expand the legislation to address several other FDA-
related issues, for example, follow-on biologics and genetic testing, have thus far
been unsuccessful. Differences between the bills may be addressed in conference.
This report contains a side-by-side comparison of S. 1082 and H.R. 2900, and
includes links to relevant CRS reports. It will be updated as further legislative events

In troduction ......................................................1
List of Tables
Table 1. Prescription Drug User Fees..................................3
Table 2. Medical Device User Fees....................................6
Table 3. Medical Device Regulation...................................9
Table 4. Pediatric Research Incentives (BPCA).........................12
Table 5. Mandatory Pediatric Assessments (PREA)......................16
Table 6. Pediatric Medical Devices...................................19
Table 7. Drug Safety..............................................24
Table 8. Antibiotic Drugs..........................................36
Table 9. Clinical Trials Databases....................................38
Table 10. Conflicts of Interest.......................................46
Table 11. Importation of Prescription Drugs............................49
Table 12. Reagan-Udall Foundation..................................50
Table 13. Food Safety.............................................53
Table 14. Domestic Pet Turtle Market Access..........................56
Table 15. Other Provisions.........................................57

FDA Legislation in the 110 Congress:
A Side-by-Side Comparison of
S. 1082 and H.R. 2900
Both chambers of Congress have passed comprehensive legislation to
reauthorize expiring programs at the Food and Drug Administration (FDA) and to
expand the agency’s authority to help ensure the safety of certain medical products.
The bills are the Food and Drug Administration Revitalization Act (S. 1082) and the
Food and Drug Administration Amendments Act of 2007 (H.R. 2900). S. 1082 and
H.R. 2900 represent the most comprehensive FDA legislation since the Food and
Drug Administration Modernization Act of 1997 (FDAMA; P.L. 105-115).
The primary driver of the legislation is the renewal of FDA’s authority for two
key user fee programs set to expire at the end of FY2007: the Prescription Drug User
Fee Act (PDUFA; P.L. 107-188) and the Medical Device User Fee and
Modernization Act (MDUFMA; P.L. 107-250). FDA had reportedly urged Congress
to complete its reauthorization efforts before August 1, 2007 (rather than by the
program’s termination date of October 1, 2007), because of a requirement that FDA
notify employees at least 60 days in advance of layoffs, which would be necessary
without PDUFA and MDUFMA funds.1 The media report that FDA has switched
to reserve funds to forestall the issuance of layoff notifications, the effect of which
is a hiring freeze at FDA.2 In addition, the FDA Commissioner has reportedly
stressed that the funding uncertainty is harming the morale of employees — 30% of
which are at a point where they can retire.
The bills also would reauthorize two other expiring authorities, which are
related to pediatric pharmaceuticals: the Best Pharmaceuticals for Children Act
(BPCA; P.L. 105-115), reauthorized in P.L. 107- 109, and the Pediatric Research
Equity Act (PREA; P.L. 108-155). In addition, the bills address a number of other
issues of concern to Congress and the public.
This report presents a side-by-side analysis of S. 1082 and H.R. 2900,
highlighting the differences between the bills. It contains individual tables on topics
covered by the bills, including prescription drug user fees, medical device user fees,
medical device regulation, pediatric exclusivity incentives (BPCA), mandatory

1 Joe Reichard, “FDA Running on Budgetary Fumes, Chief Says” CQ Healthbeat News,
August 2, 2007, 4:40 p.m..
2 Anna Edney, “FDA To Avoid Layoff Notices By Dipping Into Reserves,” Congress Daily,
Health, August 2, 2007.

pediatric assessments (PREA), pediatric medical devices, drug safety, antibiotic
drugs, clinical trials databases, conflicts of interest, importation of prescription drugs,
a new Reagan-Udall Foundation, food safety, domestic pet turtle market access, and
other provisions. In general, provisions in the two bills amend FDA’s authorities in
the Federal Food, Drug and Cosmetic Act (FFDCA) or the Public Health Service Act
(PHSA). Unless otherwise noted, mention of “the Secretary” in the following tables
refers to the Secretary of Health and Human Services (HHS).
For background information on the impetus for this legislation and for an
overview of the two bills, see CRS Report RL34089, FDA Legislation in the 110th
Congress: A Guide to S. 1082 and H.R. 2900, by Erin D. Williams, Susan Thaul, and
Donna V. Porter.

Table 1. Prescription Drug User Fees
rrent Law: First enacted in 1992 to provide the FDA with a source of revenue to supplement direct appropriations from Congress, the Prescription Drug
ations have authorized the assessment, collection, and use of application, establishment, and product fees. Authorized uses
e expanded in each reauthorization the activities included in “the review of human drug applications.” Initially the funds were for the review of
approval and biologic licensing applications for marketing. For FY2002 through 2007 (PDUFA III) fees were used for limited postmarket safety activities.
ifferences Between Bills: The House bill would increase the total user fee revenue allowed by $225 million over FY2008 — FY2012 to be used for
safety activities; and would decrease that total by the amount of any increased appropriations (excluding fees) for those activities. Note: S. 1082 includes
e revenue total increase as part of its drug safety, rather than its PDUFA, title. The Senate provision, however, does not include the “reverse trigger” (as
ouse committee members referred to it in discussion) to decrease this additional fee revenue as direct appropriations increase.
roducts: CRS Report RL33914, The Prescription Drug User Fee Act (PDUFA): Background and Issues for PDUFA IV Reauthorization, by Susan Thaul.
leakTopicS. 1082H.R. 2900
://wikicationTitle I
httpendedFFDCA Sections 735 and 736 (21 U.S.C. 379g and 379h)
ent in FFDCAPlaces within FFDCA Sec. 735 the requirements that PDUFA I, II,Continues past practice by including requirements in the bill, with
and III incorporated by reference. These are performance goalreference to previous authorization bills, but does not amend the
letters from the Secretary to the congressional committees; andFFDCA.
annual fiscal and performance reports.
thorized uses of feesAdds to the list of postmarket safety activities for which the fees could be used, to include adverse event data collection systems and
improved analytical tools, and increased requirements for adverse event reporting, both to the Secretary and to the public.
Includes additional items relating to publicly available
information, adverse event summary reports, reports to Congress
on FDA Office of Surveillance and Epidemiology
recommendations, and the development of postmarket safety
performance measures.

TopicS. 1082H.R. 2900
Requires Secretary to submit an annual performance report and an annual fiscal report to the authorizing congressional committees.
availableRequires that the Secretary make publicly available on the FDARequires that the Secretary make publicly available on the FDA
terialwebsite the annual performance and fiscal reports to congressionalwebsite the minutes of all negotiations relating to the development
committees.of performance goals and plans for meeting the goals between the
FDA and the regulated industry and representatives of patient and
consumer advocacy groups.
pounded PETCreates a reduced annual establishment fee regarding an approved human drug application for a compounded positron emission
stomography (PET) drug.
Sets fee at one-fifth the annual establishment fee.Sets fee at one-sixth the annual establishment fee.
iki/CRS-RL34102enue amountsEstablishes total prescription drug user fee revenues, for each fiscal year, of $392,783,000, with various adjustments. Amends theadjustment methods for inflation (to include cost of compensation and benefits) and workload (regarding active investigational new
g/wdrug applications), and adds an adjustment for rent and rent-related costs.
leakAdds to the adjusted fee revenue total, $225 million over FY2008
— FY2012, as specified. If the total FDA appropriation amount
://wiki(calculated according to specifications and excluding fees)
httpincreases, then the allowed fee revenue total would decrease by
that amount.
Exempts from product and facility fees applications for orphan
er fees for theAdds a new FFDCA §736A to authorize the assessment and collection of fees relating to advisory review of certain drug
isory review ofadvertisements. Manufacturer requests for pre-dissemination review of advertisements would be voluntary, and FDA responses would
ertisementsbe advisory. Only manufacturers that request such reviews would be assessed the new fees, which would include an advisory review
fee and an operating reserve fee.
Section title refers to “prescription drug advertising.”Section title refers to “prescription-drug television advertising.”
Refers to the “initial public dissemination.”Refers to the “initial public broadcast.”

TopicS. 1082H.R. 2900
In definition of direct-to-consumer advertisement, refers to “to beIn definition of direct-to-consumer advertisement, refers to “to be
displayed on any television channel for less than 2 minutes.” displayed on any television channel for less than 3 minutes.” Does
Elsewhere in bill, the reference to FFDCA 735(3), in thisnot include a corrected Section number.

definition, is corrected to FFDCA Section 735(d)(3).

Table 2. Medical Device User Fees
rrent Law: The Medical Device User Fee and Modernization Act of 2002 amended the FFDCA to establish user fees for premarket reviews of devices.
A’s authority to collect these user fees will expire on October 1, 2007. MDUFMA user fees were attached only to different types of applications to FDA (not
ular annual events, such as registration). MDUFMA also incorporated, by reference, certain performance goals related to the timing of FDA’s review of
h negotiations between industry and FDA representatives. MDUFMA specifies that FDA may not collect device-
eet associated performance goals, if direct appropriations to FDA for device-related activities fall below a certain
ifferences Between Bills: H.R. 2900 excepts Indian tribes from establishment fees. It requires information on postmarket safety in an annual report. S.
ation on previous cohorts, requires publication of the reports, and writes report requirements into FFDCA. S. 1082 specifies that the
has the sole authority to make user fee refund decisions, and that they are nonreviewable.
iki/CRS-RL34102roducts: CRS Report RL33981, Medical Device User Fee and Modernization Act (MDUFMA) Reauthorization, by Erin D. Williams.
TopicS. 1082H.R. 2900
://wikicationTitle III, Subtitle ATitle II, Subtitle A
endedFFDCA Sections 737 (21 U.S.C. 379i) and 738 (21 U.S.C. 379j).
FDA gains the authority to assess three new types of fees: (1) an annual establishment registration fee (paid once each year by each
manufacturer); (2) an annual fee for filing periodic reports (generally applicable to Class III devices — those requiring FDA’s highest
level of safety controls); and (3) a fee for 30-Day Notices (submitted for modifications to manufacturing processes or methods,
typically only required for Class III devices). Other types of fees required by the FFDCA would remain in place.
duced Fee AmountsThe amounts of individual fees decrease from FY2007 to FY2008. After FY2008, fees will generally increase each year by 8.5%. For
the newly created establishment fee, the Secretary could increase the fee amount in FY2010 up to an additional 8.5% over the annual

8.5% increase if fewer than 12,250 establishments paid the fee in FY2009.

Federal or state governmental entities do not need to pay the new annual establishment registration fees.
Governmental fee exception extends to Indian tribes.

TopicS. 1082H.R. 2900
Secretary may refund portions of fees for modular applications withdrawn before FDA takes its first action, or before other subsequent
submissions are made.
Secretary has the sole authority to make refund decisions;
decisions are not reviewable.
mallFee amounts paid by small businesses are further reduced. FDA no longer considers the assets of partners and parent firms when
sinessesdetermining whether a company is a small business. Foreign businesses can qualify as small businesses, because FDA may consider
evidence of income from sources other than the federal income tax return submitted to the Internal Revenue Service.
FeesThe requirement that the Secretary deem incomplete an application from a person with a missing fee, and not accept it until all fees
owed by the person are paid, is expanded to encompass the new application fees. Secretary may not deem complete, nor accept,
registration information submitted under FFDCA §510 (Registration of Producers of Drugs and Devices) until the registration fee is
g/wThe current restriction that fees may not be assessed and the Secretary is not expected to meet any performance goals if the amount of
s.orthoritymedical device-related direct appropriations falls below a specified threshold ($205,720,000 multiplied by an annual adjustment
leakfactor), is extended through FY2012. Also extended through FY2012, a provision allowing that if the Secretary is prevented from
collecting fees during any portion of a fiscal year because of insufficient direct appropriations but may collect them later during that
://wikifiscal year, the Secretary may then begin collecting fees without any modification in the rate.
httpStatutory language specifying the calculation for previous
years is struck.
editing andThe following amounts of user fees are authorized to be collected: $48,431,000 for FY2008; $52,547,000 for FY2009; $57,014,000
ailability of Feesfor FY2010; $61,860,000 for FY2011; and $67,118,000 for FY2012. FDA is allowed to aggregate all fees collected between FY2008
and FY2011 and compare that amount to the aggregate amount authorized for the same period. A reduction will be made in fees in the
final year only if the amount collected in the four-year period exceeds the amount authorized for the same period, rather than a
reduction being made any year that fees collected exceed the authorized appropriation.

TopicS. 1082H.R. 2900
A requirement is continued through FY2013 that the Secretary submit annual progress reports to relevant congressional committees
regarding the progress of FDA in achieving fee-related performance goals specified in a letter from the Secretary, and regarding the
implementation of the authority to collect such fees.
The report includes information on all previous cohorts forThe report includes a description of the use of such fees for postmarket
which the Secretary has not given a complete response onsafety activities
all device premarket applications, supplements, and
premarket notifications in the cohort. Performance goal and
implementation reports are made available to the public.
Report requirements are written into the FFDCA.
In FDA’s development of its recommendations to the Congress for FDA performance goals and plans for meeting those goals, FDA
must again consult with an array of governmental, professional and consumer groups, publish its recommendations in the Federal
iki/CRS-RL34102Register, provide a public comment period, and hold a public meeting.
g/wRecommendations shall be revised upon consideration of
s.orpublic comments. Recommendations must be transmitted to
leakCongress. Consultation requirements written into the
httpstmarket SafetyAdditional appropriations authorized for FY2008 — FY2012 of such
ationsums as may be necessary for collecting, developing, reviewing, and
thorizationevaluating postmarket safety information on medical devices.
e DateOctober 1, 2007; however, fees will be assessed at theEffective date is date of enactment; however, fees are assessed for all
MDUFMA 2002 rate for all premarket applications,premarket applications, premarket reports, supplements, and premarket
premarket reports, supplements, and premarket notificationnotification submissions received on or after October 1, 2007.
submissions received on or after October 1, 2002 but on or
before October 1, 2007, and accepted by FDA for filing
prior to the beginning of FY2008.
Authorization to collect user fees expires on October 1, 2012. Annual report requirements would cease to be effective on January 31,


Expiration dates are written into the FFDCA.

Table 3. Medical Device Regulation
rrent Law: In addition to authorizing the collection of user fees, the Medical Device User Fee and Modernization Act of 2002 amended the FFDCA to allow
ent inspections to be conducted by accredited persons (third parties), and to institute new regulatory requirements for reprocessed single-use devices.
ifferences Between Bills: S. 1082 would require electronic registration of medical devices only upon a finding by the Secretary that the electronic
istrations is feasible, whereas H.R. 2900 would require electronic registration as a default, unless the Secretary determined that it was not
ts by the Comptroller General: (1) on the use of the 510(k) process to determine whether a new device is safe and
e, and (2) on device-caused nosocomial (i.e., hospital-acquired) infections. H.R. 2900 would require the Secretary to promulgate regulations requiring
of devices to bear a unique identifier. H.R. 2900 would require certain device manufacturers and importers to submit device malfunction reports
medical device reporting requirements (21 C.F.R. 803) or other criteria established by the Secretary.
roducts: CRS Report RL33981, Medical Device User Fee and Modernization Act (MDUFMA) Reauthorization, and CRS Report RL32826, The Medical
iki/CRS-RL34102Related Legislative Issues, both by Erin D. Williams.
TopicS. 1082H.R. 2900
://wikicationTitle III, Subtitle BTitle II, Subtitle B
endedFFDCA Sections 704(g) (21 U.S.C. 374(g)); 523(c) (21FFDCA Sections 704(g) (21 U.S.C. 374(g)); 523(c) (21 U.S.C.
U.S.C. 360m(c)); FFDCA Sections 510 (21 U.S.C. 360).360m(c)); FFDCA Sections 510 (21 U.S.C. 360); FFDCA Section 519
(21 U.S.C. 360i).
ird Party PremarketThe authority for accredited third parties to review premarket notification is extended through FY2012.
tification Review
istrationForeign and domestic producers of devices are required to register with the Secretary between October 1 and December 31 of each
year instead of by December 31 of each year.
icesThose who register with the Secretary must provide a list of drugs and devices on which they perform specific functions, such as
manufacturing and compounding, once per year between October 1 and December 31, instead of once during the month of June and
once during the month of December.

TopicS. 1082H.R. 2900
ElectronicWith regard to any establishment engaged in theRegistrations and listings under this section (including the submission of
istration andmanufacture, preparation, propagation, compounding, orupdated information) shall be submitted to the Secretary by electronic
processing of a drug, registrations under subsections (b), (c),means unless the Secretary grants a request for waiver of such
(d), and (i) of this section (including the submission ofrequirement because use of electronic means is not reasonable for the
updated information) shall be submitted to the Secretary byperson requesting such waiver.
electronic means, upon a finding by the Secretary that the
electronic receipt of such registrations is feasible, unless the
Secretary grants a request for waiver of such requirement
because use of electronic means is not reasonable for the
person requesting such waiver.
vice ElectronicWith regard to any establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device, the
iki/CRS-RL34102istration andregistration and listing information required by this section shall be submitted to the Secretary by electronic means, unless the
g/wSecretary grants a waiver because electronic registration and listing is not reasonable for the person requesting such waiver.
s.ortThe Comptroller General conducts and submits to Congress a study on
leakthe appropriate use of the premarket notification [510(k)] process as part
://wikiof the device classification process to determine whether a new device is
httpas safe and effective as a classified device.
ique IdentificationThe Secretary shall promulgate regulations establishing a unique device
stemidentification system for medical devices requiring the labeling of
devices to bear a unique identifier.
of ReportingCertain device manufacturers and importers must submit to the Secretary
ertain Devicesdevice malfunction reports pursuant to the medical device reporting
requirements (21 C.F.R. 803) or other criteria established by the

TopicS. 1082H.R. 2900
Requirements for inspections by accredited third parties are revised in three ways: (1) by reducing administrative requirements
hirdassociated with qualifying for the program; (2) by expanding participation in the program; (3) by permitting device companies to
voluntarily submit to FDA reports by third parties assessing conformance with an appropriate international quality systems standard,
such as those set by the International Standards Organization. FDA would consider the information in these reports in setting its
inspection priorities.
of NosocomialThe Comptroller General will conduct and submit to Congress a study on
elating toinfections acquired while individuals are patients at a hospital and were
evicesneither present nor incubating in the patient prior to receiving medical


Table 4. Pediatric Research Incentives (BPCA)
rrent Law: Section 505A, added to the FFDCA in 1997, authorizes FDA to give an additional six-month period of marketing exclusivity to a manufacturer
requested pediatric use studies and reports. Amended in 2002, Section 505A also provides mechanisms (though, not necessarily resources) to
patent drugs or drugs whose sponsors have declined FDA’s request.
ifferences Between Bills: The Senate bill would limit the period of exclusivity for a drug to three months if its manufacturer/sponsor had more than $1
ross U.S. sales for all its products with the same active ingredient. The House bill would continue the six-month period of exclusivity that is
roducts: CRS Report RL33986, FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective, by Susan Thaul.
iki/CRS-RL34102TopicS. 1082H.R. 2900
s.orTitle IV, Subtitle A — Best Pharmaceuticals for ChildrenTitle V — Best Pharmaceuticals for Children Act of 2007
endedFFDCA Section 505A (21 U.S.C. 355a) and Section 735(6) (21 U.S.C. 379g).
://wikiPHSA Section 409I (42 U.S.C. 284m) and Section 499(c)(1)(C) (42 U.S.C. 290b(c)(1)(C)).
httpRefines the study scope to allow the Secretary to include preclinical studies.
e groups of interest;Authorizes the Secretary to grant additional marketing exclusivity, for both new drugs and drugs already on the market, only after a
changessponsor completes and reports on the studies that the Secretary has requested in writing (including appropriate formulations of the drug
for each age group of interest), and after any appropriate labeling changes are approved, all within the agreed upon time frames.
isting exclusivitiesExcepts from exclusivity any drug with another exclusivity that is to expire in less than a specified amount of time.
Sets cut-off at less than nine months.Sets cut-off at less than one year.
Requires that the Secretary, in making study requests, consider the adequate representation of children of ethnic and racial minorities.
Requires supporting evidence if an applicant turns down a request on the grounds that developing appropriate pediatric formulations of
pleting studiesthe drug is not possible.

TopicS. 1082H.R. 2900
erse event reportsRequires applicants to submit, along with the report of requested studies, all postmarket adverse event reports regarding that drug.
Requires the Director of Pediatric Therapeutics to provide adverse event reports to the Pediatric Advisory Committee for review and
recommendations to the Secretary for action.
free number forRequires that the rule proposed by the FDA Commissioner on April 22, 2004, take effect on January 1, 2008, unless the Commissioner
er reports ofissues the final rule before that date. Excluded from the rule’s application are a drug approved under FFDCA Section 505, a
erse eventsnonprescription drug, and a drug whose packaging includes a toll-free number with which to report adverse events to the manufacturer
or distributor.
Expands the public notice requirement beyond the current notice of an exclusivity decision to include copies of the written request.
Requires the Secretary to publicly identify any drug with a developed pediatric formulation that studies have demonstrated to be safe
iki/CRS-RL34102and effective for children if its sponsor has not introduced the pediatric formulation onto the market within one year.
g/wmitteeRequires that the Secretary establish an internal review committee, composed of FDA employees with specified expertise.
s.orRefers to “pediatric ethics” as a possible expertise to include.Requires an expert in pediatric ethics.
Requires that the internal committee review all written requests.
httpRequires that the internal committee also: (1) review all studies
and reports submitted pursuant to this provision; and (2) make
recommendations to the Secretary on whether to accept or reject
the studies.
ing of studies andRequires the tracking of pediatric studies and labeling changes according to specified questions.
changesRequires that the internal committee perform this task.Assigns that responsibility to the Secretary.
In addition to information on what was done, would require
information concerning when the Secretary did not follow the
internal committee’s recommendations.
ity adjustmentLimits the period of exclusivity for a drug to three months if itsContinues the six-month exclusivity that is in current law.

sponsor has more than $1 billion in annual gross U.S. sales for all
its products with the same active ingredient.

TopicS. 1082H.R. 2900
spute resolutionEstablishes a dispute resolution process to include referral to the Pediatric Advisory Committee.
Requires that, for a product studied under this section, the labeling include study results (if they do or do not indicate safety and
effectiveness, or if they are inconclusive) and the Secretary’s determination.
Requires dissemination of labeling change information to health-care providers.
When studies of a drug with a current patent are not done, requiresWhen studies of a drug with a current patent are not done, requires
pletedthe Secretary to determine whether to require an assessment underthe Secretary to determine whether to require an assessment under
FFDCA Section 505B; otherwise, requires the Secretary, if fundsFFDCA Section 505B.
are available from the Foundation for the NIH, to refer the study to
the Foundation.
iki/CRS-RL34102If the drug has no patent in effect, requires the Secretary to referthe drug for inclusion on the list established under PHSA § 409I.If a drug has no patent in effect, requires the Secretary, ifprescription drug user fee funds are available, to award a grant to
g/wconduct the study; otherwise, to refer the drug for inclusion on the
s.orlist established under PHSA § 409I;.
Requires the Secretary to report (1) decisions not to issue a written request, and (2) referrals to NIH under PHSA Section 409I.
httpRequires that the notice include the drug’s name, manufacturer,
and the indications to be studied.
portsRequires a study and report from the Institute of Medicine (IOM).
Directs that the IOM report include recommendations for
incentives for encouraging pediatric studies of biologics.
Requires a report from the Government Accountability Office.
ed drugs forRegarding the requirement that the Secretary, through the NIH Director and in consultation with the FDA Commissioner, list approved
drugs for which pediatric studies are needed to assess safety and effectiveness. The bills would change the specifications from an
annual list of approved drugs to a list, revised every three years, of priority study needs in pediatric therapeutics, including drugs or
indications. They would direct the Secretary to fund studies on those issues.

TopicS. 1082H.R. 2900
ation forFor activities pursuant to PHSA Section 409I, authorizes $200 million for FY2008 and such sums as may be necessary for the
subsequent four fiscal years.
er feesAuthorizes the use of prescription drug user fee revenue for
contracted pediatric studies not conducted by a drug’s sponsor.
Adds pediatric pharmacological research to the areas covered byNo provision.

the Pediatric Research Loan Repayment Program (PHSA Section



Table 5. Mandatory Pediatric Assessments (PREA)
rrent Law: Requires a manufacturer, when submitting an application to market a new active ingredient, new indication, new dosage form, new dosing
imen, or new route of administration, to submit a pediatric assessment. The submission must be adequate to assess the safety and effectiveness of the product
ed indications in all relevant pediatric subpopulations; and to support dosing and administration for each pediatric subpopulation for which the
e. There are specified situations in which the Secretary may waive or defer the requirement. If the disease course and drug effects are
similar for adults and children, the HHS Secretary may allow extrapolation from adult study data as evidence of pediatric effectiveness, usually
ented with other data from children, such as pharmacokinetic studies.
arket, the Secretary may require the manufacturer to submit a pediatric assessment in situations in which not having pediatric use
ation on the label could pose significant risks. Before requiring an assessment, the Secretary must have issued a written request under FFDCA Section
, and the manufacturer must not have agreed to conduct the assessment. If a manufacturer does not comply with the Secretary’s
, the Secretary may consider the product misbranded.
g/wifferences Between Bills: Current law links the program’s authorization to the five-year authority it provides to the pediatric exclusivity program. The
s.orould eliminate that connection; the Senate bill would continue it.
://wikiroducts: CRS Report RL33986, FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective, by Susan Thaul.
TopicS. 1082H.R. 2900
cationTitle IV, Subtitle BTitle IV
Pediatric Research ImprovementPediatric Research Equity Act of 2007
endedFFDCA Section 505B (21 U.S.C. 355c)

mitteeRequires the Secretary to establish an internal committee, composed of FDA employees with specified expertise, to participate in the
review of pediatric plans and assessments, deferrals, and waivers.
Requires documentation of the internal committee’s activity, tracking of pending assessments, and the placement of the information on
the FDA website for easy public access.
Requires that the internal committee perform these tasks.Assigns that responsibility to the Secretary.
Requires that the internal committee conduct a retrospective
review and analysis of assessments, deferrals, and waivers to the
Secretary, who would be required to issue recommendations for
applicationsFor assessments that result in labeling changes, requires FDA to consider as priority applications the manufacturers’ supplemental
applications to make those changes.
iki/CRS-RL34102Establishes a dispute resolution procedure for when a sponsor does not agree with the FDA Commissioner’s request for a label change;
g/win those cases, requires the Commissioner to refer the dispute to the Pediatric Advisory Committee for review and recommendation. If
s.orthe sponsor continues to disagree with a requested labeling change, the Commissioner may deem the drug to be misbranded.
Requires that the Commissioner refer the dispute to the Pediatric
://wikiAdvisory Committee within 30 days of a sponsor’s disagreeing to
httpchange the label.
inationIncludes various provisions involving dissemination of assessment findings to the public and health-care providers.
verse eventsIncludes reporting requirements for adverse events, and their review by the Office of Pediatric Therapeutics and, if requested, the
Pediatric Advisory Committee.

portsRequires a study and report from the Institute of Medicine.
Requires a report from the Government Accountability Office (GAO).
GAO report due by Sept. 1, 2010.GAO report due by Sept. 1, 2011.
Include whether the number of FDA’s written requests that
sponsors decline increased or decreased under these amendments.
Include a description of the Secretary’s actions, recommendations,
and efforts to increase neonatal studies.
thorizationAs in current law, links the authority to carry out the aboveEliminates the provision linking the authority to carry out the
provisions to the five-year authority provided to the pediatricabove provisions to authorization of the pediatric exclusivity
exclusivity program.program.


Table 6. Pediatric Medical Devices
rrent Law: The process of approving new medical devices for marketing in the United States is generally governed by the FFDCA, Chapter V. Medical
ices may be tested in clinical trials demonstrating their safety and effectiveness, leading to FDA approval for marketing, or demonstrated to be substantially
to a device already on the market, leading to FDA clearance for marketing. Applications related to devices intended to treat pediatric populations are
exempted from user fees according to FFDCA § 738(a)(2)(B)(v) — pediatric conditions of use. Devices designed for small patient populations may
for the Humanitarian Device Exemption (HDE), that waives the effectiveness requirement and user fees (21 U.S.C. 360j(m)). HDE manufacturers are
selling their devices for an amount that exceeds the costs of research and development, fabrication, and distribution of the device. The price is
ated number of devices to be sold. The Secretary sets this number for each device, and it may not exceed 4,000. Device applications
to pediatric conditions of use are exempt from fees (FFDCA 738 (a)(2)(B)(v)).
ifferences Between Bills: S. 1082’s modification to the HDE expires in 2012; H.R. 2900’s expires in 2013. H.R. 2900 requires an annual review of
remain appropriate. H.R. 2900 requires the FDA Commissioner to create a plan for expanding pediatric medical device
iki/CRS-RL34102elopment. H.R. 2900 enables a manufacturer to request dispute resolution of certain orders or conditions requiring postmarket surveillance,
g/w which time the device shall not be deemed misbranded unless necessary to protect the public health. S. 1082 requires demonstration grant recipients to
s.or to the Secretary on the effectiveness of their activities. S. 1082 requires Office of Pediatric Therapeutics to submit a plan for expanding
leakedical device research and development. The bills contain different conditions for when the Secretary may require a postmarket study as a condition
://wikiice approval.
httproducts: CRS Report RL32826, The Medical Device Approval Process and Related Legislative Issues, by Erin D. Williams.
TopicS. 1082H.R. 2900
cationTitle IV, Subtitle CTitle III
endedFFDCA chapter V (21 U.S.C. 351 et seq.): Sections 520(m) (21 U.S.C. 369j(m)) and 522 (21 U.S.C. 360l).
BPCA Sections 6(b) (21 U.S.C. 393a(b)) and 14 (42 U.S.C. 284m note).
PHSA Section 402(b) (42 U.S.C. 282 (b))

TopicS. 1082H.R. 2900
w DevicesCertain applicants are required to include, if readily available, a description of any pediatric subpopulations (neonates, infants,
children or adolescents — defined in amended §520(m)(6)(E)(ii)) that suffer from the condition the device is intended to treat, and the
number of affected pediatric patients. Requirements apply to persons submitting an application to FDA under one of two FFDCA
sections: (1) § 515 — a premarket application (PMA) to market a class III device (class III devices are those that require FDA’s
highest level of safety controls); (2) § 520(m) — an HDE application.
The Secretary submits an annual report to the Senate Health, Education, Labor, and Pensions (HELP) and House Energy and
Commerce Committees that includes, for the preceding year: (1) the number of devices approved for which a pediatric subpopulation
suffers from the disease or condition the device is intended to treat; (2) the number of devices labeled for pediatric use; (3) the number
of approved pediatric devices exempted from a fee pursuant to pediatric conditions of use; and (4) the review times for applications
described above.
termination ofThe Secretary may conclude that adult data can be used to support a reasonable assurance of effectiveness in pediatric subpopulations,
iki/CRS-RL34102enessas appropriate.
g/wA study for each pediatric subpopulation may not be necessary if data from one could be extrapolated to another.
A person granted an HDE is permitted to sell his device for an amount that exceeds the costs of research and development, fabrication,
://wikianitarian Deviceand distribution of the device if the following criteria were met: (1) the device is intended to treat and is labeled for use in a pediatric
httpemptionsubpopulation; (2) the device was not approved for pediatric use prior to the act’s date of enactment; (3) the number of devices
distributed does not exceed a distribution number specified by the Secretary that may not exceed the number specified by the Secretary
for the HDE; (4) the applicant immediately notifies the Secretary if the number of devices distributed exceeds the allowable annual
distribution number; and
(5) the request is submitted on or before October 1, 2012. (5) the request is submitted on or before October 1, 2013.
DEIf a person fails to demonstrate continued compliance with pediatric HDE requirements, the Secretary must provide notice and an
mpliance, Inspectionopportunity for a hearing before suspending or withdrawing exemption from effectiveness requirements. The Secretary may inspect the
records relating to the number of devices distributed during any calendar year for any person granted an HDE exemption from
effectiveness requirements under the new pediatric rule. A person may petition the Secretary to change, and the Secretary may modify
up to 4,000, the number of devices sold under the new pediatric HDE. If the Secretary discovers through notification or inspection that
the number of devices marketed exceeded the projected annual distribution number, the sale price restriction will apply from that point

TopicS. 1082H.R. 2900
Requires the Secretary to report adverse events regarding devices granted a pediatric HDE to the Office of Pediatric Therapeutics
(OPT). OPT Director provides a periodic review of the reports by the Pediatric Advisory Committee, obtains the Committee’s
erapeuticsrecommendations, and reports back to the Secretary.
OPT provides for an annual review by the Committee of all
devices granted the pediatric HDE to ensure that the exemption
remains appropriate.
mptroller GeneralBy January 1, 2012, the Comptroller General submits a report to the Senate HELP and House Energy and Commerce Committees on
the impact of the new pediatric HDE, including, among other elements:
An evaluation of demonstration grants for improving pediatricAn evaluation of the demonstration grants for improving pediatric
device availability (required by the bill) that have been or aredevice availability (required by the bill).
being studied in children, and that have been submitted to the
iki/CRS-RL34102FDA for approval, clearance, or review under an HDE (FFDCA
g/wSection 520(m), as modified by this Act) and any regulatory
s.oractions taken.
idanceWithin 180 days of enactment, requires the FDA Commissioner to issue guidance for institutional review committees on how to
://wikievaluate requests for approval for devices for which an HDE has been granted.
httpNIH Director’s duties are modified in PHSA, requiring theNIH Director shall designate a point of contact or office at the
ailable FundingDirector to designate a point of contact or office to help innovatorsNIH to help innovators and physicians access funding for pediatric
and physicians identify some sources of funding available formedical device development.
pediatric medical device development (42 U.S.C. 282(b)).
ediatricRequires the FDA Commissioner, in collaboration with various
eviceagency heads, to submit to the Senate HELP and House Energy
searchand Commerce Committees a plan for expanding pediatric medical
device research and development. (Contents specified in bill).

TopicS. 1082H.R. 2900
onstration GrantsWithin 90 days of enactment, requires the Secretary to issue a request for proposals (RFP) for one or more grants or contracts to
nonprofit consortia for demonstration projects to promote pediatric device development. Secretary determines application content and
submission time and manner. Within 180 days of RFP, requires the Secretary to make a determination on the grants or contracts.
A nonprofit consortium that receives a grant or contract under thisA nonprofit consortium that receives a grant or contract under this
section shall facilitate the development, production, andsection shall —
distribution of devices by — (list of requirements parallel to S. 1082 except):
(list of requirements parallel to H.R. 2900 except):(5) assess business feasibility and provide business advice;
(5) providing assistance and advice as needed on business(6) provide assistance with prototype development; and
development, personnel training, prototype development,(7) provide assistance with postmarket needs, including training,
postmakret needs, and other activities consistent with the purposeslogistics and reporting
of this section.
iki/CRS-RL34102Requires that grantees coordinate with the NIH point of contact for available funding (created by the act), and provide NIH with
g/wonstration Grantsidentified pediatric device needs the consortium lacks the capacity to address, or in which the consortium has been unable to stimulate
s.ormanufacturer interest. Grantees coordinate with the FDA Commissioner to facilitate the application for approval of devices labeled for
leakpediatric use.
://wikiRequires that grantees report annually to the Secretary on theeffectiveness of their activities, their impact on pediatric device
httpdevelopment, and the status of pediatric device development
facilitated by the consortium.
onstration GrantAuthorizes the appropriation of $6,000,000 for each of FY2008 through FY2012 to carry out the pediatric medical device
thorizationdemonstration grant activities called for in the act.
The duties of FDA’s OPT are expanded to include increasing pediatric access to medical devices.
erapeuticsRequires OPT, in collaboration with the directors of other
specified agencies, to submit to the Senate HELP and House
Energy and Commerce Committees a plan for expanding pediatric
medical device research and development, including the current
status of, gaps in, and a plan for improving pediatric medical
device development, product approval or clearance, and evaluation
of safety and effectiveness.
dvisoryExpands the Secretary’s authority to convene and consult an advisory committee on pediatric therapeutics specifically to include the
mmitteetopic of increasing access to pediatric medical devices.

TopicS. 1082H.R. 2900
marketThe surveillance approval paragraph of the medical device postmarket surveillance section of the FFDCA (522; 21 U.S.C. 360l) is
rveillanceamended to allow for the Secretary to require, as a condition of approval, postmarket studies of longer than 36 months for devices that
are expected to have a significant use in pediatric populations, if the extended time is necessary to assess the safety of the device. The
in general paragraph, which gives the Secretary authority to order postmarket studies, is amended to include pediatric medical devices
as follows:
1) IN GENERAL-(a) IN GENERAL. — The Secretary may by order or as a
(A) CONDUCT- The Secretary may by order require acondition to approval of an application (or a supplement to an
manufacturer to conduct postmarket surveillance for any device ofapplication) or a product development protocol under Section 515
the manufacturer that is a class II or class III device — or as a condition to clearance of a premarket notification under
(i) the failure of which would be reasonably likely to have seriousSection 510(k), for a pediatric population or pediatric
adverse health consequences;subpopulation, require a manufacturer to conduct postmarket
iki/CRS-RL34102(ii) that is expected to have significant use in pediatricpopulations; orsurveillance for any device of the manufacturer which is a class IIor class III device the failure of which would be reasonably likely
g/w(iii) that is intended to be — to have serious adverse health consequences, or that is indicated
s.or(I) implanted in the human body for more than 1 year; orfor pediatric populations or subpopulations or is expected to have
(II) a life-sustaining or life-supporting device used outside asignificant use in pediatric populations, or which is intended to be
://wikidevice user facility.—
http(B) CONDITION- The Secretary may order a postmarket(1) implanted in the human body for more than one year, or
surveillance under subparagraph (A) as a condition to approval or(2) a life-sustaining or life-supporting device used outside a device
clearance of a device described in subparagraph (A)(ii).user facility.
`(2) RULE OF CONSTRUCTION- The provisions of paragraph
(1) shall have no effect on authorities otherwise provided under
the Act or regulations issued under this Act.’
Permits a manufacturer to request a review under FFDCA Section
562 (dispute resolution) of any order or condition requiring
postmarket surveillance under this section, during which time the
device shall not be deemed misbranded under Section 502(t) or
otherwise in violation of such order or condition or a related
requirement of this act unless necessary to protect the public

Table 7. Drug Safety
rrent Law: Since 1938, the Federal Food, Drug, and Cosmetic Act (FFDCA) has required that drugs be safe and, since 1962, that they be effective (which is
ant to safety for drugs that have adverse as well as beneficial effects). The FFDCA gives FDA the authority to regulate drugs (and biologics licensed under
ublic Health Service Act), including clinical testing, marketing approval and postmarketing safety and effectiveness monitoring. Current law allows FDA
arket study as a condition of its initial approval of a marketing application, but does not authorize FDA to add such requirements after
al. Current law does not provide for civil penalties, authorizing only the revocation of approval or licensing (or the threat of revocation) to compel
nufacturers to change labeling or advertising. FDA does not have the authority to require manufacturers to submit advertising material for review or
al before dissemination.
ifferences Between Bills: The bills differ mostly in their details rather than in their basic approach. They vary in their authorization of civil penalties
. A few provisions appear in only one or the other bill.
iki/CRS-RL34102roducts: CRS Report RL32797, Drug Safety and Effectiveness: Issues and Action Options After FDA Approval, by Susan Thaul.
leakTopicS. 1082H.R. 2900
://wikicationTitle II — Drug Safety, Subtitle A — Risk Evaluation andTitle IX — Risk Evaluation and Mitigation Strategies (REMS)
httpMitigation Strategies (REMS)
endedAmends FFDCA Sections 303 (21 U.S.C. 333), 502 (21 U.S.C.Amends FFDCA Sections 301 (21 U.S.C. 331), 303 (21 U.S.C.

352), 505 (21 U.S.C. 355), 735 (21 U.S.C. 379g), and 736 (21333), 502 (21 U.S.C. 352), and 505 (21 U.S.C. 355).

U.S.C. 379h).Adds FFDCA Sections 503B, 505-1, and 511.
Adds FFDCA Sections 506D and 566.Amends PHSA Section 351 (42 U.S.C. 262).

Amends PHSA Section 351 (42 U.S.C. 262).

TopicS. 1082H.R. 2900
arket studies andAuthorizes the Secretary to require postapproval studies or clinical trials.
Included as a potential REMS element.Is not included within the REMS provisions.
Requires that the Secretary, to require a postapproval study orRequires that the Secretary, to require a postapproval study or
clinical trial, make the determination that other reports orclinical trial to assess a known serious risk or signals of serious
surveillance would be inadequate to assess a signal of serious riskrisk, or to identify a serious risk, make the determination on the
or to identify unexpected serious risks.basis of scientific information.
Authorizes the Secretary to require a postapproval study or clinical
trial after learning of new safety information to include timetables
and periodic reports. Requires a sponsor that fails to comply with
such requirements to demonstrate good cause.
iki/CRS-RL34102Requires that any trial required under this section be included in
g/wthe clinical trial registry data bank.
s.or changesAuthorizes the Secretary, upon learning of new relevant safety information, to require that the sponsor submit a supplement for a
leaklabeling change; creates procedures, including time limits, for notification, review, dispute resolution, and violation.
://wikiIncluded as a new FFDCA Section 506D.Amends FFDCA Section 505.


TopicS. 1082H.R. 2900
evaluation andAuthorizes the Secretary to require that the sponsor of a drug or biologic application or supplement to an application submit a proposed
ation strategiesREMS.
Authorizes the Secretary to require a REMS, with fewer elements, for a product under an abbreviated new drug application.
Prohibits the sale of a new drug or biologic if it is not in
compliance with an approved REMS or if the sponsor fails to
conduct a postmarket study that is required following approval
under subpart H of 21 U.S.C. 314.
Requires a sponsor to submit a statement along with an application
about whether it believes a REMS should be required.
Requires a sponsor to submit a REMS if the Secretary (actingPre-approval: If the Secretary determines such a strategy is
iki/CRS-RL34102through the office responsible for reviewing the drug and thenecessary to ensure that the benefits of the drug involved outweigh
g/woffice responsible for postapproval safety with respect to the drug)the risks of the drug.
s.ordetermines that, based on a signal of a serious risk with the drug, it
leakis necessary to assess such signal or mitigate such serious risk.Postapproval: If the Secretary becomes aware of new safety
://wikiinformation and determines a REMS necessary.
httpThe Secretary’s authority also extends to an application for a new
indication for use and an abbreviated new drug application.
Regarding noncompliance with a REMS requirement that had
been added after a product’s approval, after notice and opportunity
for a hearing, requires the Secretary to publish in the Federal
Register a statement of noncooperation.
Requires a sponsor to submit a REMS if the Secretary determines
from data or information in an application that the following are
necessary: postapproval studies or clinical trials, information to
patients or clinicians, pre-review of advertisements, disclosures in
advertisements, or ensuring access.

TopicS. 1082H.R. 2900
entsRequires assessments of an approved REMS.
No less frequently than 18 months and 3 years after a drug isNo less frequently than once annually for the first 3 years after the
initially approved; and, subsequently, at a frequency (includingREMS is approved; in the seventh year; and, subsequently, at a
none) as the Secretary determines.frequency (including none) as the Secretary determines.
Product labeling.
Information to patients, to include Medication Guide and patient package insert.
entsCommunication plan to health care providers, such as letters, information about REMS, and explanations of safety protocols.
Restrictions on distribution or use; along with a system to monitor implementation, the Secretary’s evaluation of the elements to assure
safe use, waiver for use of certain medical countermeasures in the time a declared public health emergency, and minimizing burdens
on patient access to a drug and on the health care delivery system.
iki/CRS-RL34102Allows expanded access for an off-label use for a serious or life-
g/wthreatening disease or condition.
Allows safe access to drugs with known serious risks that would
://wikiotherwise be unavailable.
httpIncludes a few provisions regarding how any restrictions on the
distribution of an approved drug relate to generic drug
applications; for example, prohibits a sponsor from using a
restriction on distribution to block or delay approval of a generic
drug application.
Postapproval studies or clinical trials[Included in separate, non-REMS, section.]
Preview of advertisements[Included in separate, non-REMS, section.]

TopicS. 1082H.R. 2900
entsPermits a sponsor to submit a voluntary assessment of an approved REMS at any time.
Requires assessments at prearranged times; and when the Secretary determines that new information indicates an existing element
should be modified or included.
Requires that the Secretary’s determination be based on newRequires that the Secretary’s determination be based on new
safety information.safety or effectiveness information.
Requires an assessment of how well the elements to assure safe use are meeting the goal of increasing safe access to drugs with known
serious risks and whether the goal or such elements should be modified; and an assessment of the status of required postapproval
studies and clinical trials.
odificationsAllows modifications to include the assessment timetable; or the addition, modification, or removal of a restriction on distribution or
iki/CRS-RL34102Allows other modifications: a labeling change; the addition or
g/wmodification of a postapproval study or clinical trial requirement;
s.oror the addition, modification, or removal of an element on
leakadvertising, or an element to assure safe use.
://wikiDoes not require a REMS assessment for a labeling change for
httpwhich a supplemental application is not required, or for which
distribution of the drug may commence upon the receipt by the
Secretary of a supplemental application for the change.

TopicS. 1082H.R. 2900
iewAmends the FFDCA (S. 1082 places it as a new paragraph 505(o); H.R. 2900 creates a new Section 505-1) to require that the Secretary
promptly review each proposed REMS and each assessment of an approved REMS. Specifies the procedures, including timeframes, for
that review. These include dispute resolution, including review by a Drug Safety Oversight Board (made up of federal government
scientists and health care practitioners), use of advisory committees, and administrative appeals; addressing drug class effects; and
coordinating assessment timetables with efforts of other countries.
Requires that a dispute resolution occurring before an initial
approval follow procedures set forth in the letters described in
FFDCA Section 735(a).
Authorizes the Secretary to require a sponsor, as part of a REMS
review, to submit information regarding its marketing plan and
practices for the drug, so as to allow the Secretary to determine
iki/CRS-RL34102whether any of the proposed or ongoing marketing activities
g/wundermine any of the requirements of the REMS. Does not
s.orauthorize the Secretary to make or direct any change in the
leakmarketing plan or practices involved.
://wikiplianceS. 1082 Section 202 — for FFDCA Section 505(o)(9): For anapplicant that knowingly fails to comply with a requirement of anNo civil monetary provision within the REMS sections (i.e.,FFDCA 505(o), 505(p), or 505-1).
httpapproved REMS, creates a civil monetary penalty of $250,000 for
the first 30-day period that the applicant is in noncompliance, with
such amount doubling each 30-day period thereafter that the
requirement is not complied with, not to exceed $2 million.
vertisements:Authorizes the Secretary to require a prereview (at least 45 days before dissemination) of advertisements to ensure the inclusion of a
iewtrue statement of information in brief summary relating to a serious risk listed in the labeling of a drug, or relating to a protocol to
ensure the safe use described in the labeling of the drug.
A potential element of a REMS.New FFDCA Section 503B.
Refers to “advertisements.”Refers to “television advertisement.”
Does not authorize the Secretary to make or direct changes in any
material submitted pursuant to this section.
Requires the Secretary to take into consideration the impact of the
advertised drug on elderly populations, children, and racially and
ethnically diverse communities.

TopicS. 1082H.R. 2900
vertisements: Authorizes the Secretary to require inclusion of a disclosure in an advertisement if the Secretary determines that the advertisement
would be false or misleading without a specific disclosure about a serious risk listed in the labeling of the drug involved.
Includes authority to require a disclosure concerning a protocol to
ensure safe use as described in the drug’s labeling.
Authorizes the Secretary to require the advertisement to include a specific disclosure of the approval date if the Secretary determines
that the advertisement would otherwise be false or misleading.
Does not specify a time limit for the approval date disclosure.Specifies that the approval date disclosure may not to exceed 2
years from the date of the drug’s approval.
If the Secretary requires a specific disclosure as part of a REMS,
the Secretary must: (1) consider identifying and assessing all
iki/CRS-RL34102serious risks of using the drug to be a priority safety question
g/wunder the surveillance and assessment section of FFDCA; (2) not
s.orless frequently than every 3 months, evaluate surveillance reports
leakto determine whether serious risks that might occur among
patients expected to be treated with the drug have been adequately
://wikiidentified and assessed; (3) remove the disclosure requirement if
httprisks have been adequately identified and assessed; and (4)
consider whether the disclosure should be required.
S. 1082 Sec. 519(b); H.R. 2900 Sec. 901(b). Amends FFDCA Sec. 502(n), for a television or radio direct-to-consumer (DTC)
advertisement of a prescription drug that states the name of the drug and its conditions of use, to require that the major statement
relating to side effects and contraindications be presented in a clear and conspicuous manner.
Inserts “(neutral)” between “clear and conspicuous” and
“manner.” (See previous row.)
vertisements:Amends FFDCA Section 502(n) to require that any DTC
ll-free numberadvertisement include the following statement: “You are
encouraged to report adverse effects of prescription drug
medication to the FDA. Log onto [http://www.fda.gov/medwatch]
or call 1-800-FDA-1088.”

TopicS. 1082H.R. 2900
vertisements: CivilS. 1082 Section 519; H.R. 2900 Section 902(a). Amends FFDCA Section 303 to establish civil penalties for the sponsor of a drug or
biologic who disseminates a DTC advertisement that is false or misleading.
Authorizes a civil monetary penalty not to exceed $150,000 for theAuthorizes a civil monetary penalty not to exceed $250,000 for the
first violation in any 3-year period, and not to exceed $300,000 forfirst violation in any 3-year period, and not to exceed $500,000 for
each subsequent violation in any 3-year period.each subsequent violation in any 3-year period.
No other civil monetary penalties in this act shall apply to a
violation regarding DTC advertising.
Repeated dissemination of the same or similar advertisement prior to the receipt of a written notice shall be considered one violation.
After such notification, all violations under this paragraph
occurring in a single day shall be considered one violation.
iki/CRS-RL34102Specifies procedures, after providing written notice and opportunity for a hearing, regarding reviews, subpoenas, modifications, and
g/wjudicial review. (Generally equivalent in S. 1082 and H.R. 2900.)
s.orIf an applicant fails to pay an assessed civil penalty, authorizes the Attorney General to recover that amount plus interest.
Requires the Secretary to report annually to the Congress on DTC
://wikiadvertising and its ability to communicate to subsets of the general
httppopulation, and establish a permanent advisory committee with
respect to the report.
ent:Included as misbranding the failure to comply with certain requirements.
Applies to REMS requirements regarding a labeling change orApplies to REMS requirements regarding assessments, additional
advertising.elements included, or a restriction on distribution or use.
Applies to non-REMS requirements relating to postmarket studies
and clinical trials or labeling.

TopicS. 1082H.R. 2900
ent: CivilS. 1082 Section 203(b) — for FFDCA Section 303(f): Makes anH.R. 2900 Section 902(b) — for FFDCA Section 303: Makes an
applicant who knowingly fails to comply with a REMSapplicant who violates a REMS requirement or a requirement
requirement subject to a civil money penalty between $15,000 andregarding postmarket studies or clinical trials or labeling subject to
$250,000 per violation, and not to exceed $1 million for all sucha civil monetary penalty of not more than $250,000 per violation,
violations adjudicated in a single proceeding.and not to exceed $1 million for all such violations adjudicated in
a single proceeding.
If a violation continues after the Secretary provides notice of such
violation to the applicant, authorizes the Secretary to impose a
civil penalty of not more than $10 million per violation, and not to
exceed $50 million for all such violations adjudicated in a single
iki/CRS-RL34102For a violation that is continuing in nature and poses a substantial
g/wthreat to the public health, authorizes the Secretary to impose a
s.orcivil penalty not to exceed $1 million for each day that such
leakperson is in violation.
://wikiulation ofical productsAmends PHA Section 351 to permit an applicant for a license tosubmit a REMS as part of the application.Amends PHA Section 351 to require an applicant for a license tobe subject to FFDCA Section 505(p) — Risk Evaluation and
httpMitigation Strategy.
effect onAmends FFDCA Section 505(e), adding that the Secretary may withdraw the approval of an application or suspend the approval of an
application without first ordering the applicant to submit an assessment of the approved REMS.
nefit-riskRequires that, within a year of enactment, the FDA Commissioner
entssubmit to Congress a report on how best to communicate to the
public the risks and benefits of new drugs and the role of the
REMS in assessing such risks and benefits. As part of such study,
the Commissioner shall consider the possibility of including in the
labeling and any DTC advertisements of a newly approved drug or
indication a unique symbol indicating the newly approved status of
the drug or indication for a period after approval.

TopicS. 1082H.R. 2900
sourcesAdds to the list of activities for which user fee revenue can beNote: A similar provision appears in Title I (Prescription Drug
used to include the reviewing, implementing, and ensuringUser Fees) of H.R. 2900.
compliance with REMS.
Amends FFDCA Section 736 to increase by $225 million the totalNote: A similar provision appears in Title I (Prescription Drug
revenue amounts determined for FY2008 through FY2012.User Fees) of H.R. 2900.
ation technologyRequires that the Secretary submit to the Senate HELP and
Appropriations Committees, and the House Energy and Commerce
and Appropriations Committees, a strategic plan on information
technology. Requires that elements of the plan: include an
assessment of infrastructure needed by FDA to comply with
requirements; achieve interoperability within FDA and with
iki/CRS-RL34102product application sponsors; use electronic health records;
g/wimplement a routine active surveillance; communicate drug safety
s.orinformation to health care providers; and provide an assessment of
leakthe extent to which the infrastructure is sufficient, a plan for
enhancing IT assets, and an assessment of additional resources
httparket drug safetyRequires that the Secretary, within one year of enactment, develop
ation for patientsand maintain an Internet website with an extensive range of drug
iderssafety information, including summaries of surveillance data, and
documents from drug approval and biologics licensing
applications such as a summary of conclusions from all reviewing
disciplines and staff disagreements and recommendations.

TopicS. 1082H.R. 2900
For drugs and biologics, requires the Secretary to publish on the
ages for approvalFDA website, within 30 days of approval, the entire Action
Package; and to publish, within 48 hours of a drug’s approval, a
summary review that documents (without disclosing trade secrets
or confidential information) conclusions from all reviewing
disciplines, noting critical issues and disagreements with the
applicant and how they were resolved, recommendation for action
and an explanation of any nonconcurrence with review
conclusions; a separate review, if applicable, from a
nonconcurring supervisor; and identification (with consent) of
FDA participants in the decision. Scientific review shall not be
altered by management or review once final; disagreements with
iki/CRS-RL34102major conclusions shall be documented in a separate review or in
g/wan addendum.
s.or communicationRequires the Secretary to establish an Advisory Committee on
Risk Communication. Requires that the Secretary partner with
://wikinongovernmental groups to develop robust and multifaceted
httpsystems for communication to health care providers about
emerging postmarket drug risks.
ferral to advisoryRequires that the Secretary, before approving a drug that includes
mitteea new active ingredient, refer the drug to an FDA advisory
committee. Referral may be delayed up to one year postapproval
in specified situations relating to therapeutic results or public
OM 2006Requires that the Secretary submit a report, within one year,
responding to the recommendations in the IOM 2006 report The
Future of Drug Safety, to include an assessment of FDA’s
implementation of REMS requirements.
tive surveillance andRequires the Secretary to establish public-private partnerships to develop a postmarket risk identification and analysis system using
entelectronic databases.
Note: The timetables and order of activities vary between the bills.

TopicS. 1082H.R. 2900
ainst(H.R. 2900, Section 909) Makes a prohibited act (under FFDCA
s orSection 301, and therefore subject to FFDCA penalties), the
ical productsintroduction of drugs or biologics that are either FDA
e been addedapproved/licensed, or for which substantial clinical investigations
have been instituted and made public, unless: (1) the drug or
biologic is marketed in food before FDA approval/licensure and
before clinical investigations are instituted, or (2) the Secretary
issues a regulation, after notice and comment, approving its
addition to food.
e datesUser fee for review of drug advertising begins October 1, 2007. All provisions in Title IX begin 180 days after enactment.

All other provisions in Subtitle A of Title II begin 180 days after

Table 8. Antibiotic Drugs
rrent Law: The FDA regulates antibiotics as drugs, under FFDCA §505. Orphan drugs, which may be antibiotics, are those that affect less than 200,000
ore than 200,000 persons if there is no reasonable expectation that the cost of developing and making the drug available
nited States will be recovered from sales in the United States. PDUFA application fees do not apply to orphan drugs. The Secretary may encourage the
elopment of orphan drugs by awarding grants and contracts, and may, in certain circumstances, ensure the drugs’ continued availability by issuing an
al to a second party within the usual period of market exclusivity.
ifferences Between Bills: H.R. 2900 would require the Secretary to issue guidance for the conduct of clinical trials of antibiotic drugs, and require the
to convene a public meeting regarding orphan antibiotic products. It would also authorize appropriations of $30 million for each of the next five fiscal
rants and contracts to develop orphan drugs. S. 1082 would consider antibiotics as orphan products and authorize $35 million for each of those fiscal
he Senate bill includes other provisions regarding antibiotic access and innovation; one would provide incentives (extended marketing exclusivity) for
elopment of certain antibiotics.
leakTopicS. 1082H.R. 2900
://wikiTitle II, Subtitle F, Antibiotic Access and InnovationTitle IX
httpendedSections in Chapter V, Subchapter A of the FFDCA (as noted), as amended by this act.
es for§ 261. Amends § 505 of the FFDCA (21 U.S.C. § 355), asNo comparable provision.
elopmentamended by this act. Makes certain antibiotic drugs eligible for
market exclusivity if an application for marketing is submitted
after enactment of this act for an antibiotic drug that was approved
by the Secretary before November 21, 1997; or was the subject of
one or more applications received by the Secretary before
November 21, 1997, none of which was approved.
s§ 262 in S. 1082; § 911 in H.R. 2900. Requires the FDA Commissioner to convene a public meeting and issue guidance, if
appropriate, regarding whether certain infectious diseases may be designated as rare diseases, making drug development for treating
such diseases eligible for assistance pursuant to the Orphan Drug Act (21 U.S.C. § 360ee).
Reauthorizes grants and contracts for orphan drugs (21 U.S.C. §Reauthorizes grants and contracts for orphan drugs (21 U.S.C. §
360ee), including authority for such sums as already have been360ee), authorizing the appropriation of $30 million for each of
appropriated for FY2007, and $35 million for each of FY2008FY2008 through FY2012.

through FY2012.

TopicS. 1082H.R. 2900
Susceptible§ 263. The Secretary, through the FDA Commissioner, shallNo comparable provision.
identify, and periodically update and publish, “clinically
susceptible concentrations” of antimicrobial drugs.
ity of Certain§ 264. Amends § 505 of the FFDCA [21 U.S. C. 355], as amendedNo comparable provision.
s Containingby this subtitle, adding a new provision allowing an applicant for a
le Enantiomersnon-racemic drug containing, as an active ingredient a single
enantiomer that is contained in a racemic drug approved in another
application, to elect to have the single enantiomer considered the
same active ingredient as that contained in the approved racemic
drug, under certain circumstances.
t§ 265. Requires the Comptroller General, by January 1, 2012, toNo comparable provision.
iki/CRS-RL34102report to Congress regarding the effect of provisions in this
g/wsubtitle in encouraging the development of new antibiotics and
s.orother drugs; and preventing or delaying timely generic drug entry
leakinto the market.
://wikiuidancentibiotic DrugsNo comparable provision.§ 908. Amends Chapter V of the FFDCA [21 U.S.C. § 351 etseq.], adding a new § 511. Requires the Secretary, within one year
httpof enactment, to issue guidance for the conduct of clinical trials
with respect to antibiotic drugs, and to review and update such
guidance within five years of enactment.

Table 9. Clinical Trials Databases
rrent Law: Registration is currently required for clinical trials of drugs (but not biologics or medical devices) intended to treat serious or life-threatening
. Trials are now registered at clinicaltrials.gov.
ifferences Between Bills: H.R. 2900 provides instructions for the immediate creation of a database containing clinical trial results; S. 1082 would
to create a database via rulemaking. H.R. 2900 contains more requirements than S. 1082 for when a principal investigator may serve as a
, and for registry submissions. It also links the definition of completion date to the collection of data relevant to primary and secondary
es, and would require registry updates every six months. S. 1082 exempts newly created pediatric postmarket surveillance clinical trials from registry
ents, and allows for the voluntary registration of clinical trials that are not required to be submitted. S. 1082 specifies more criteria than does H.R. 2900
which the registry must be searchable, specifies a timeline by which the NIH Director must make registry information public, and would require the registry
to certain public clinical trial results information.
iki/CRS-RL34102roducts: CRS Report RL32832, Clinical Trials Reporting and Publication, by Erin D. Williams.
TopicS. 1082H.R. 2900
://wikicationTitle II, Subtitle C — Clinical TrialsTitle VIII - Clinical Trial Databases
endedFFDCA Section 505(i) (21 U.S.C. 355(I)).
PHSA Section 402 (42 U.S.C. 282). FFDCA Sections 301 (21PHSA Title IV (42 U.S.C. 281, et seq.). FFDCA Sections 505(d) (21
U.S.C. 331); 303(f) (21 U.S.C. 333(f)); 505(b) (21 U.S.C.U.S.C. 355(d)); 520(g)(2) (21 U.S.C. 360j(g)(2)); 510 (21 U.S.C.

355(b)); 510(k) (21 U.S.C. 360(k)); 515(c) (21 U.S.C. 360e(c);360); and 515(d) (21 U.S.C. 360e(d)).

and 520(m)(2) (21 U.S.C. 360j(2)).
istry and/orExpands the registry and includes links to certain results. Expands the registry and establishes a results database.
sults DatabaseResults database to be created by HHS Secretary rulemaking
following recommendations to be made in NIH Director’s
report about best, validated method of making trial results
publicly available.
ypes Drugs, devices, and biologics.

TopicS. 1082H.R. 2900
ccessYes, via Internet.
REGISTRY: Internet posting and Freedom of Information ActBOTH (i.e., Registry and Results Database): FOIA request disclosures
(FOIA) request disclosures limited to terms of the act. not available for results for which the principal investigator is seeking
Secretary promulgates regulations that notice of posting bepublication.
part of informed consent.Old versions of updated postings remain available, with trackable
changes the public can see.
National Library of Medicine at NIH
REGISTRY: Either supplants or builds on clinicaltrials.gov,
whichever is more efficient.
s Registry andREGISTRY: Entries link to certain existing results.BOTH: Corresponding registry and results database entries link to one
iki/CRS-RL34102sults another.
g/witsResponsible party (RP).
s.orationREGISTRY: RP is sponsor. If no sponsor exists, RP isBOTH: RP is primary sponsor as defined by World Health
grantee, contractor or awardee of federal funding. IfOrganization. RP may be principal investigator (PI) if designated by
://wikidesignated by sponsor, grantee, contractor or awardee, RP issponsor and if PI is responsible for conducting the trial, has access to
httpprincipal investigator (PI).and control over data, has the right to publish trial results, and has the
authority to meet the RP responsibilities.
eceivesNIH Director


TopicS. 1082H.R. 2900
ing of SubmissionREGISTRY:REGISTRY:
-Initially: not later than 21 days after the first patient is-Initially: not later than14 days after first patient is enrolled.
enrolled.-Updates: not less than once every 6 months.
-Change in enrollment status: not later than 30 days after-Change in Enrollment Status: not later than 30 days after change.
change.-Notice of trial completion: Not later than 30 days after final
-Completion of trial: not later than 30 days after the lastcollection of data from subjects for primary and secondary outcomes.
patient enrolled in the clinical trial has completed his or herRESULTS:
last medical visit, whether the clinical trial conducted-Generally: Not later than 1 year after earlier of estimated or actual
according to the prespecified protocol or plan was terminatedcompletion date (extensions possible).
(extensions possible).-Updates: every 6 months for 10 years from when initial posting was
-Changes in regulatory status: within 30 days after change.
iki/CRS-RL34102ing of PostingREGISTRY:REGISTRY:
g/w-Trials of drugs and biological products: within 30 days of-Not specified (NIH Director ensures the registry information is made
s.orsubmission.publicly available via Internet) except that NIH Director may not
-Trials of devices: within 30 days of clearance under Sectionmake registry information about device trials public until the device is
://wiki510(k) of the FFDCA or approval under Sections 515 orapproved or cleared by FDA.
http520(m) of the FFDCA.RESULTS: (delays of up to 2 years possible if seeking publication)
-Links to trial results (from FDA and NIH information) that-Pre-approval studies: not later than 30 days after approval or issuance
form the basis of an efficacy claim or are conducted after theof not approvable letter.
drug or biologic is approved or the device is cleared or-Summaries of medical, clinical pharmacology reviews of pre-
approved: not earlier than 30 days after the date of approval orapproval and new use studies: within 90 days of applicable date.
clearance, not later than 30 days after the product becomes-Post-approval studies generally: within 30 days of submission.
publicly available.-Post-approval studies of new uses in which manufacturer is a trial
sponsor and certifies it is seeking or will seek approval within 1 year:
not later than 30 days after approval, issuance of not approvable letter,
or application withdrawal; or 2 years after certification.

TopicS. 1082H.R. 2900
-Indication, using Medical Subject Headers
-Enrollment status
-Trial sponsor
-Safety issue being studied
-Study phase-Indication, using Medical Subject Headers
-Age group (including pediatric subpopulations)-Status of FDA application
-Study location-Trial phase
-National Clinical Trial number or other identification number-Product name
-Each financial sponsor
iki/CRS-RL34102-Safety issue being studied
g/wncluded REGISTRY: BOT H:
s.or-Device trials: prospective study of health outcomes-Drug, device, biologic clinical trials: trials testing a product’s safety
leakcomparing an intervention against a control in human subjectsor effectiveness if conducted in the United States or if the product has
intended to support an application under Section 520 (m)FDA approval or is the subject of an application for FDA approval.

://wiki[humanitarian devices] or 515 [premarket approval of devices]
httpor a report under Section 510(k) [device clearance] of the
FFDCA; pediatric postmarket surveillance as required under
Section 522 of the FFDCA (as amended by the bill).
-Drug and biologic trials: a controlled clinical investigation of
a product subject to FFDCA Section 505 [drug approval] or
PHSA Section 351 [approval of biological products].
-Other trials: voluntary submissions possible.

TopicS. 1082H.R. 2900
-Device trials: limited studies to gather essential information-Pharmacokinetic and toxicity studies: a clinical trial to determine the
used to refine the device or design a pivotal trial and that is notsafety of a use of a drug that is designed solely to detect major
intended to determine safety and effectiveness of a device.toxicities in the drug or to investigate pharmacokinetics, unless the
-Drug and Biologic Trials: Phase I trials.clinical trial is designed to investigate pharmacokinetics in a special
population or populations.
-Feasibility studies: a small clinical trial to determine the feasibility of
a device, or a clinical trial to test prototype devices where the primary
focus is feasibility.
gistry Data Elements-World Health Organization’s International Clinical Trials Registry Platform data set
-City, state, zip code, toll-free number of study
iki/CRS-RL34102-Whether there is expanded access for unapproved drugs and biologics under FFDCA Section 561 [emergency situations, patientaccess to treatments for serious diseases, treatment uses]
g/w-Elements specified by Secretary
leak-Links to results from certain FDA submissions, NIH-Estimated completion date
information (Medline cites and NLM database of product-RP identity and contact information
://wikilabels), and previously existing databank entries-Restrictions on non-employees’ discussion or publication of results


TopicS. 1082H.R. 2900
entsNone.-Registry data elements, plus:
-Each sponsor
-Scientific point of contact
-Description of patient population
-Summary data describing achievement of primary and secondary
endpoints, assessment of secondary endpoints, safety information
-Information about subjects who quit trial
-Restrictions on non-employees’ discussion or publication of results
-Link to peer reviewed publications
-Completion date
-FDA adverse regulatory action
g/w-Point of contact
s.or-General description of results, trial design changes, and reasons for
leak change s
://wikiBOTH REPORTS:-Trial purpose
http-Trial sponsor
-General description of results, trial design changes, and reasons for
NIH Director to include links to Medline citations, NLM database
product labels, prior databank entries.

TopicS. 1082H.R. 2900
ent and-RP ensures submissions not false or misleading.
-No federal agency may release research grant funds to noncompliant RPs.
-For applicable trials funded by FDA, NIH, AHRQ, or VA,-Secretary consults with other federal agencies to determine whether
progress report forms include certification of compliance. studies funded by them and conducted under 45 C.F.R. 46 [federal
Agency heads verify compliance before releasing grant fundsprotections for human subjects] are applicable clinical trials, and to
to RPs. Secretary consults with other federal agencies todevelop procedures to ensure results submission.
determine whether studies funded by them and conducted-NIH Director checks registry to ensure corresponding results are
under 45 C.F.R. 46 [federal protections for human subjects]filed. After notice to RP, and opportunity to correct, Director reports
merit similar procedures.noncompliance to federal agencies and Office of Human Research
-Applications or submissions under FFDCA Sections 505, 515,Protections, and posts notice of noncompliance in registry and
iki/CRS-RL34102520(m), or 510(k), or PHSA Section 351 [new drugs, biologicsand devices], must have certifications of compliance. database.-FDA Commissioner to verify submissions are made for trials in
g/w-Secretary may impose FFDCA penalties for noncompliance. applications under FFDCA Sections 505, 505(i) 515, 520(g), or
s.or510(k), or PHSA Section 351 [new or exempt drugs, biologics and
devices]. After 30 days after notice, failure to correct leads to
://wikiSecretary’s refusal to file, approve, or clear application.
http-Secretary to review documents to ensure they are non-promotional,
not false or misleading. 30 days after notice of noncompliance,
penalties may apply.
-Secretary may impose FFDCA penalties for noncompliance,
including civil monetary penalties created by the act (not more than
$10,000/day, and not more than $15,000 for all violations of an
individual or nonprofit adjudicated in a single proceeding).
RESULTS: NIH Director conducts a study to determine theBOTH: Not later than 1 year after enactment, Comptroller General
best, validated methods of making trial results public after thesubmits a report to Congress on a study to determine whether
approval of a drug that is the subject of an applicable druginformation in the registry and database is considered promotional and
trial. Director submits findings to HHS Secretary within 18to evaluate the implementation of the database.
months of initiating study.
edAuthorizes appropriations of $10,000,000 each fiscal year.

TopicS. 1082H.R. 2900
ptionNo state or political subdivision of a state may require or effect registration of trials or results.
Compliant submissions shall not be considered (1) by Secretary as evidence of a new intended use different from labeling, or (2) as
FFDCA labeling, adulteration, or misbranding.
-Generally: October 1, 2007-Databases established not later than 1 year after enactment.

-Regulations become effective 90 days after HHS Secretary’s
issuance of final rule. (Final rule issued pursuant to Act to be
issued not later than 18 months after Act’s enactment, and
after notice and comment.)
-Funding restrictions take effect 210 days after regulations’
effective date.

Table 10. Conflicts of Interest
rrent Law: Current law generally requires that FDA advisory committee members be free from conflicts of interest, but allows for exceptions to that rule
stances. Under FDA’s current approach, a conflict of interest may require a potential committee member to disclose the conflict, refrain
voting, and/or not participate in a committee, depending on the nature of the conflict. (5 U.S.C. Appendix; 21 U.S.C. 355(n);18 U.S.C. chapter 11, §208.)
ifferences Between Bills: H.R. 2900 would only allow one waiver per meeting of a voting restriction allowable if necessary to provide the committee
permits the participation of a non-voting guest expert with financial interest if the Secretary determines that the
est has particular required expertise.
roducts: CRS Report RS22691, FDA Advisory Committee Conflict of Interest Reform Efforts in the 110th Congress, by Erin D. Williams.
g/wTopicS. 1082H.R. 2900
s.orcationTitle II, Subtitle DTitle VII
leakendedFFDCA chapter VII, subchapter A (21 U.S.C. 371 et seq.); Section 505(n) (21 U.S.C. 355(n)).
://wikivisory CommitteeFederal Advisory Committee Act (FACA) committee that provides advice or recommendations to the Secretary regarding the FDA.
httpnterestAs defined in 18 U.S.C. 208(a): [A committee member who] participates personally and substantially as a government officer or
employee, through decision, approval, disapproval, recommendation, the rendering of advice, investigation, or otherwise, in a judicial
or other proceeding, application, request for a ruling or other determination, contract, claim, controversy, charge, accusation, arrest, or
other particular matter in which, to his knowledge, he, his spouse, minor child, general partner, organization in which he is serving as
officer, director, trustee, general partner or employee, or any person or organization with whom he is negotiating or has any
arrangement concerning prospective employment, has a financial interest. [Notes: The scope of disqualifying financial interests under
18 U.S.C. 208(a) have been interpreted to include any potential for gain or loss to the employee, which would include interests such as
stock ownership (5 C.F.R. 2640.103(b)). Exemptions and waivers apply (18 U.S.C. 208(b)). Penalties apply (18 U.S.C. 216).

entRequires the Secretary to develop and implement strategies on effective outreach to potential members of advisory committees at
universities, colleges, other academic research centers, professional and medical societies, and patient and consumer groups. The
Secretary shall seek input from professional medical and scientific societies to determine the most effective informational and
recruitment activities. The Secretary shall also take into account the advisory committees with the greatest number of vacancies. Both
bills list a number of identical activities that may be included (e.g., advertising at medical and scientific society conferences).
The Secretary shall act through the Office of Women’s Health, the
Office of Orphan Product Development, the Office of Pediatric
Therapeutics, and other FDA offices with relevant expertise.
aluationWhen considering a term appointment to an advisory committee, the Secretary shall review the expertise of the individual and the
financial disclosure report filed by the individual pursuant to the Ethics in Government Act of 1978 for each individual under
consideration for the appointment, so as to reduce the likelihood that an appointed individual will later require an exemption or waiver
under 18 U.S.C. 208(b).
iki/CRS-RL34102est ParticipationAn individual with a financial interest with respect to any matter
g/wconsidered by an advisory committee may be allowed to participate in a
s.ormeeting of an advisory committee as a guest expert if the Secretary
leakdetermines that the individual has particular expertise required for the
meeting. An individual participating as a guest expert may provide
://wikiinformation and expert opinion, but shall not participate in the discussion
httpor voting by the members of the advisory committee.
sclosure of InterestsPrior to a meeting of an advisory committee, each member of the committee shall disclose to the Secretary financial interests in
accordance with subsection 18 U.S.C. 208(b).
ting Prohibition andNo member of an advisory committee may vote with respect to any matter considered by the advisory committee if such member (or
ption froman immediate family member of such member) has a financial interest that could be affected by the advice given to the Secretary with
respect to such matter, excluding interests exempted in regulations issued by the Director of the Office of Government Ethics as too
remote or inconsequential to affect the integrity of the services of the Government officers or employees to which such regulations
er The Secretary may grant a waiver of the voting prohibition if such waiver is necessary to afford the advisory committee essential

er LimitationsThe Secretary may not grant a waiver (under the newly created section above) for a member of an advisory committee when the
member’s own scientific work is involved.
Secretary shall not grant more than one waiver (under the newly created
section above) per committee meeting.
er DisclosureFor waivers granted under the terms of the bill or under 18 U.S.C. 208(b), the Secretary must disclose on the FDA website the type,
nature, and magnitude of the pertinent financial interests and the reasons for the Secretary’s action. The disclosure would be limited so
as not to include information that is not subject to a FOIA request. The Secretary would be required to make the disclosure not less
than 15 days prior to an advisory committee meeting, or, in the event that the financial interests became known to the Secretary less
than 30 days prior to the meeting, no later than the date of the meeting. Required disclosures would be included in the public record
and transcript of each meeting.
eportThe Secretary must submit annual reports to relevant congressional committees describing advisory committee vacancies, nominees,
and the number of nominees willing to serve; the number of conflict-related disclosures per meeting and the percentage of members
iki/CRS-RL34102who did not require such disclosures; the number of times required disclosures occurred less than 30 days in advance of meetings; and
g/whow the Secretary plans to reduce the number of vacancies on advisory committees and increase the number of nominations, including
s.orthose of academicians or practitioners.
leakiewThe Secretary must review and update FDA conflict of interest guidance not less than once every five years.
://wikiingRedundant provisions in 21 U.S.C. 355(n) would be deleted. The effect of moving the provisions is that they will apply to all FDA
httpendmentFACA advisory committees, not just those focused on drugs and biologics.
e DateOctober 1, 2007

Table 11. Importation of Prescription Drugs
rrent Law: Under current law, it is illegal for anyone to import a prescription drug other than its manufacturer. The law includes provisions for pharmacists
holesalers to import, but provides that they not become effective until the HHS Secretary certifies that the importation program would be safe and offer
ings to U.S. consumers. Secretaries in both the Clinton and George W. Bush Administrations have declined to provide that certification.
ifferences Between Bills: The importation provisions are only in S. 1082.
roducts: CRS Report RS22660, Prescription Drug Importation: How S. 242 / H.R. 380 Would Change Current Law, and CRS Report RL32511,
jectives, Options, and Outlook, both by Susan Thaul.
iki/CRS-RL34102TopicS. 1082
g/wcationTitle VIII-Importation of Prescription Drugs
s.orendedPrimarily FFDCA Section 804
isionsAllows commercial and personal-use importation, providing the Secretary first certifies that the drugs to be imported under the
://wikiprogram would “pose no additional risk to the public’s health and safety;” and “result in a significant reduction in the cost of covered
httpproducts to the American consumer.”
Creates a detailed set of procedures to address concerns relating to the safety and effectiveness of imported drugs, cost savings to U.S.
consumers, and administration of the program.
Required procedures include registration; monitoring, inspecting, and testing; packaging and labeling; wholesale distribution; Internet
pharmacies; exporter and commercial importer fees; and reports.

Table 12. Reagan-Udall Foundation
rrent Law: No comparable provision.
ifferences Between Bills: Provisions in the two bills are nearly identical, with one substantive difference noted in the comparison below. Also, S.
akes reference to provisions becoming effective upon enactment of the Enhancing Drug Safety and Innovation Act of 2007, the bill (S. 484) from which
TopicS. 1082H.R. 2900
Title II, Subtitle B (§§ 221, 222)Title VI
w AmendedAmends FFDCA Chapters VIII and IX (21 U.S.C. 371 et seq., and 391 et seq.) Creates a new §§ 770, 910.
iki/CRS-RL34102 Amends FFDCA, Chapter V, Subchapter E (21 U.S.C. 360bbb et
s.orseq.). Creates a new § 566.
leakEstablishes a nonprofit corporation to be known as the Reagan-Udall Foundation for the Food and Drug Administration (The
tablishment andFoundation), to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product
://wikidevelopment, accelerate innovation, and enhance product safety. Lists duties of the Foundation, criteria for formation, conduct duties,
httpterms and administrative powers of the Board of Directors, and the Executive Director. Stipulates the roles of federal employees
involved in the Foundation’s functions.
Duties of the Foundation include “taking into consideration theDuties of the Foundation include those listed for S. 1082, and, after
Critical Path reports and priorities published by the Food and“cosmetics,” “including the incorporation of more sensitive and
Drug Administration, identify unmet needs in the development,predictive tools and devices to measure safety...”
manufacture, and evaluation of the safety and effectiveness,
including postapproval, of devices, including diagnostics,
biologics, and drugs, and the safety of food, food ingredients,
and cosmetics...”
The ex officio members of the Board shall serve as incorporators and shall take whatever actions necessary to incorporate the
Foundation. The Foundation shall be considered a corporation under Section 501(c) of the Internal Revenue Code of 1986, and shall be
subject to the provisions of such section.

TopicS. 1082H.R. 2900
The Executive Director may solicit and accept on behalf of the Foundation, any funds, gifts, grants, devises, or bequests of real or
personal property, including from private entities, for the purposes of carrying out the duties of the Foundation. The Executive
Director shall ensure that the funds received from the U.S. Treasury are held in separate accounts from funds received from other
To carry out certain provisions in this subtitle, from amounts appropriated to the FDA for each fiscal year, the Commissioner shall
transfer to the Foundation not less than $500,000 and not more than $1,250,000.
Recipients of grants, contracts, fellowships, memoranda of understanding, or cooperative agreements from the Foundation shall report
to the Foundation regarding their activities on an annual basis.
Beginning with FY2009, the Executive Director shall submit to Congress and the FDA Commissioner an annual report on the
Foundation’s activities
iki/CRS-RL34102The Foundation shall, if practicable, be located not more than 20 miles from the District of Columbia.
s.orctivitiesThe FDA Commissioner shall, with respect to the Foundation: receive and assess the required annual reports; and, beginning with
leakFY2009, submit to Congress an annual report summarizing the information provided by the Foundation, and other required
://wikiinformation. The provisions of this subchapter shall have no effect on any grant, contract, memorandum of understanding, orcooperative agreement between the FDA and any other entity entered into before, on, or after the date of enactment. § 742(b) of the
httpFFDCA (21 U.S.C. 379l(b)) is amended by adding at the end the following: “Any such fellowships and training programs under this
section or under Section 770(d)(2)(A)(ix) may include provision by such scientists and physicians of services on a voluntary and
uncompensated basis, as the Secretary determines appropriate. Such scientists and physicians shall be subject to all legal and ethical
requirements otherwise applicable to officers or employees of the Department of Health and Human Services.”
hiefA new section in FFDCA requires the Secretary to create an Office of the Chief Scientist within FDA’s Office of the Commissioner.
ientist(Duties specified).

TopicS. 1082H.R. 2900
itical Path Public-Adds a requirement to FFDCA’s general provisions relating to drugs
ate Partnershipsand devices (Title V, Subchapter F), that the Secretary, through the
FDA Commissioner, enter into collaborative agreements (Critical
Path Public-Private Partnerships) with educational or tax-exempt
organizations to implement the FDA Critical Path Initiative by
developing innovative, collaborative projects in research, education,
and outreach for the purpose of fostering medical product innovation,
enabling the acceleration of medical product development, and
enhancing medical product safety; and authorizes to be appropriated
$5 million for FY2008 and such sums as may be necessary for each
of FY2009 through FY2012.


Table 13. Food Safety
rrent Law: Most of the provisions below would establish new authorities. Amendments to current law are noted when appropriate. FDA food safety
eneral, found in Title IV of the FFDCA (21 U.S.C. § 341 et seq.), with reference when appropriate to other titles (e.g., Title III, regarding
ifferences Between Bills: H.R. 2900 does not contain provisions on this topic.
roducts: CRS Report RS22600, The Federal Food Safety System: A Primer, by Geoffrey S. Becker and Donna V. Porter, and CRS Report RS22664, U.S.
, by Geoffrey S. Becker.
iki/CRS-RL34102TopicS. 1082
g/wcationTitle VI
s.or AmendedGenerally FFDCA, various sections
of Pet Food§ 602. Within 18 months, the Secretary, in consultation with other stakeholders, shall by regulation establish processing and
://wikiingredient standards for pet foods, animal waste and ingredient definitions, and update nutrition and ingredient labeling of pet
httpfood. Within 180 days, the Secretary shall, by regulation, establish an early warning and surveillance system to identify
adulteration of the pet food supply and outbreaks of illness associated with pet food. The Secretary shall, in establishing such
system, use surveillance and monitoring mechanisms similar to, or in coordination with, those used by CDC, consulting with
relevant professional organizations, and working with existing notification networks, to inform veterinarians and others during a
recall of pet food.
munication§ 603. During an ongoing recall of human or pet food, the Secretary shall work with relevant stakeholders to collect and
aggregate pertinent information through existing networks of communication, including electronic forms, and post information
regarding the recall on FDA’s website, in an easily accessible form.

TopicS. 1082
§ 604. The Secretary shall work with the states on activities and programs that assist in improving the safety of fresh and
processed produce, to facilitate coordination and cost-effectiveness. The Secretary shall encourage states to strengthen their
food safety programs, especially for retail commercial food establishments, and establish procedures and requirements for
ensuring that processed produce is not unsafe for human consumption. The Secretary may provide assistance to states in
implementing their food safety programs in the following areas: advisory, technical, training, laboratory and financial. The
Secretary may under an agreement use, on a reimbursable basis, the personnel, services and facilities of the agency to assist
istry§ 605. Amends Title IV of the FFDCA, creating a new § 417, requiring the Secretary, within 6 months, to establish an
Requirementsadulterated food registry within FDA, to which reportable adulterated food cases may be submitted via electronic portal, by
public health officials, importers, persons responsible for producing or marketing food, or consumers. The Secretary shall review
and determine the validity of information submitted, for the purposes of identifying adulterated food, and exercising other
iki/CRS-RL34102existing food safety authorities to protect the public. The Secretary shall issue an alert, if a food has been associated withrepeated and separate outbreaks of illness or incidents of adulteration, or is a reportable adulterated food. Such an alert may
g/wapply to a particular food, producer, shipper, growing area or country, where applicable. If a food producer or importer suspects
s.orthat a food is adulterated, he is required within five days to determine if it is a reportable adulterated food, and if such
determination is made, to, within two days, notify responsible parties in the food supply to and from which it was transferred.
://wikiThat individual is then required to notify the FDA within two days through the electronic system, unless the determination of
httpadulteration was detected prior to any transfer of the food which was destroyed, making a report to FDA unnecessary. The
provisions outline the data elements required for reporting to FDA for the registry. Records must be maintained and available for
inspection, if needed. The Secretary shall immediately notify the Secretary of Homeland Security if he suspects such food may
have been deliberately adulterated. Amends § 301 of the FFDCA to prohibit: failure to provide a report, or the falsification of a
report, for a food considered to be adulterated. The Secretary shall, within 180 days, promulgate regulations that establish
standards and thresholds by which importers and producers are required, and consumers allowed, to report instances of
suspected reportable adulterated food to FDA for the registry. Requirements in this section become effective in 6 months.
§ 606. The section addresses congressional responsibility to provide FDA with additional resources, authorities, direction, and
inspectors to safeguard the U.S. food supply. It directs that the Secretary should prioritize efforts to reach agreements with U.S.
trading partners on food safety, and the Senate should work to develop a comprehensive response to the food safety issue.
ress Regarding§ 607. The Secretary shall submit to the relevant congressional committees, annually, a report that includes the number and
ported Foodsamount of imported food products regulated by FDA, aggregated by country and type of food; the number of FDA inspectors of
imported foods and number of inspections performed on those products; and aggregated date on the findings of those
inspections, including violations and enforcement actions taken as a result.

TopicS. 1082
le of Construction§ 608. Nothing in this title affects the regulation or the adverse event reporting system for dietary supplements created under the
Dietary Supplement Health and Education Act of 1994 or the Dietary Supplement and Nonprescription Drug Consumer
Protection Act.
ation of§ 609. There are authorized to be appropriated to carry out this title (and the amendments made by this title) such sums as may
be necessary.


Table 14. Domestic Pet Turtle Market Access
rrent Law: Pursuant to regulations at 21 C.F.R. 1240.62, viable turtle (defined) eggs and live turtles with a carapace (shell) length of less than 4 inches shall
other type of commercial or public distribution. FDA may humanely destroy eggs or turtles found in violation of
ulation. An appeals procedure is described. Persons in violation of this regulation shall be subject to a fine of not more than $1,000 or imprisonment for
ore than 1 year, or both, for each violation. The FDA Commissioner may amend this regulation upon his own initiative or in response to a petition.
ade, including sale for scientific, educational, or exhibitional purposes. The provision is administered by FDA’s Center for Veterinary
ifferences Between Bills: H.R. 2900 does not contain provisions on this topic.
iki/CRS-RL34102TopicS. 1082
g/wcationTitle VII
leakendedNot stated. Authority for the current prohibition is based in Public Health Service Act Sections 215, 311, 361 and 368. (42 U.S.C. 216,

243, 264 and 271.) [General authorities for disease control.]

http TurtlesThe FDA shall not restrict the sale by a turtle farmer, wholesaler, or commercial retail seller of a turtle that is less than 10.2 centimetersin diameter (approx. 4 inches), if the seller meets the requirements of a state or territorial program that licenses the seller; requires
veterinary certification of sanitization; said sanitization includes a proven non-antibiotic method to make the turtle salmonella-free; and
buyers are provided with information regarding safe handling of the turtle with respect to future disease risks.
view ofThe FDA Commissioner may, after providing an opportunity for the affected state to respond, restrict the sale of a turtle only if the
Secretary determines that the actual implementation of state health protections described in this title is insufficient to protect consumers
against infectious diseases acquired from such turtle at the time of sale.

Table 15. Other Provisions
rrent Law: Most of the provisions below would establish new authorities. Amendments to current law are noted when appropriate.
ifferences Between Bills: With two exceptions, beginning on page 60, these provisions are found only in S. 1082.
TopicS. 1082
cationTitle II Subtitle E-Other Drug Safety Provisions; and Title V-Other Provisions
ended(Noted when applicable)
ed GenericSec. 251. Would amend FFDCA Section 505 to require that the FDA Commissioner (within nine months of enactment) publish on the
iki/CRS-RL34102sFDA website a list of all authorized generic drugs; update the list quarterly; and notify relevant federal agencies of those updates.
g/wDefines, for this section, an authorized generic drug as one that had previously been approved under Section 505(c) and then
s.or“marketed, sold, or distributed directly or indirectly to retail class of trade under a different labeling, packaging (other than
leakrepackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code,
://wikitrade name, or trade mark than the listed drug.”
httpuanaSec. 252. Requires that the Secretary require that state-legalized medical marijuana be subject to the full FDA regulatory
requirements, including a risk evaluation and mitigation strategy (REMS) and all other requirements and penalties of the FFDCA (21
U.S.C. 301 et seq.) regarding safe and effective reviews, approval, sale, marketing, and use of pharmaceuticals
ientific Articles§ 501. Amends Subchapter A of chapter VII of the FFDCA, as amended by Section 241. The Secretary, through the FDA
FDACommissioner, shall establish and make publicly available clear written policies to implement this section and govern the timely
ployeessubmission, review, clearance, and disclaimer requirements for articles. Requires employee to submit articles to appropriate
supervisory FDA personnel for review not less than 30 days prior to publication or presentation. Requires supervisory FDA personnel
to provide written clearance, which may include conditions, within 30 days of submission. If supervisory personnel do not provide
written clearance within 30 days, employee may submit work for publication or presentation, with disclaimer.
endments§ 502. Miscellaneous technical amendments.

ublic Health
ice Act

TopicS. 1082
erability§ 503. If any provision of this act, or any amendment made by this act, or the application of such provision or amendment to any
person or circumstance is held to be unconstitutional, the remainder of this act, the amendments made by this act, and the application
of the provisions of such to any person or circumstances shall not be affected thereby.
on Biologics§ 504. Includes a Sense of the Senate statement regarding providing FDA with appropriate authority to review follow-on biologics.
ents for Tropical§ 505. Amends Subchapter A of chapter V of the FFDCA, adding a new § 524. The Secretary shall award a priority review voucher
seases: Priorityto the sponsor of a tropical disease product (defined) upon approval by the Secretary of such product (after the enactment of this
viewsprovision). The voucher, which is transferrable, would entitle the bearer to priority review of a new drug application, submitted under
FFDCA § 505(b)(1), after the date of approval of the tropical disease product. The Secretary shall establish a user fee program to
support priority reviews.
sticide Residue§ 507. Requires annual online publication of FDA report on pesticide residue monitoring with information and analysis, identifying
iki/CRS-RL34102products or countries that require special attention and additional study. The Ginseng Dietary Supplements Special Survey is to be
g/wincluded, along with the relative number of domestic and import shipment samples and a description of commodities improperly
s.orimported as another commodity. Reports for FY2004 through FY2006 are to be combined into a single report by June 1, 2008, with
leakfuture reports completed by June 1 each year. The Commissioner of FDA, the Administrator of the Food Safety and Inspection
Service, the Department of Commerce, and the head of the Agricultural Marketing Service shall enter into a memorandum of
://wikiunderstanding to permit inclusion, in the reports required above, of data relating to testing carried out by the Food Safety and
httpInspection Service and the Agricultural Marketing Service on meat, poultry, eggs, and certain raw agricultural products.
ct§ 508. Amends the Head Start Act [42 U.S.C.§§ 9831 et seq.] by adding a new § 657A. Requires a Head Start agency to obtain
endmentwritten parental consent before administration of any nonemergency intrusive physical examination (defined) of a child in connection
with participation in a program under this subchapter.
of Food§ 509. Within 90 days of enactment, FDA is required to issue a report on whether substances used to preserve the appearance of meat
escreate health hazards or mislead consumers.
est Safety and§ 510. Requires the Secretary, within 30 days of enactment, to enter into a contract with the Institute of Medicine to study and assess
alitythe overall safety and quality of genetic tests, and prepare, within one year of contract award, a report that includes recommendations
to improve federal oversight and regulation of genetic tests.
§ 511. Includes the finding that FDA approved drugs are often not approved for treatment of pediatric orphan diseases, and a Sense of
ent in Childrenthe Senate statement that FDA should enter into a contract with the Institute of Medicine to study the problem.

TopicS. 1082
lor Additive§ 512. Amends § 721 of the FFDCA. Requires FDA to submit a report to Congress, within 90 days of the close of each fiscal year, that
rtification Reportsdescribes the number of batches of color additives approved, the average time for approval and quantifiable goals for improving
laboratory efficiencies. A second report on the financial status is required, within 120 days of the end of the fiscal year, that includes
all fees and expenses of the program, the balance of funds available, and the anticipated costs during the next fiscal year, of the color
additive certification program.
ported Food§ 513. Prohibits the importation of food from a foreign food facility, registered with FDA, that refuses to permit inspection, or unduly
delays access to that facility by U.S. inspectors.
nspections§ 515. Authorizes the Secretary to enhance FDA’s aquaculture and seafood inspection regime consistent with international
agreements and U.S. law. Requires a report to Congress, within 90 days of enactment, that describes the specifics of the inspection
program, the feasibility of developing traceability systems for catfish and seafood products to processing plants (foreign and domestic)
iki/CRS-RL34102and an assessment of the risks associated with contaminants and banned substances. The provision allows partnership agreements withthe states to implement the inspection program for imported products, and authorizes the appropriation of such sums as are necessary
g/wto implement the program.
leak§ 516. Includes findings regarding the problem of patent infringement, statement urging the United States Trade Representative to use
nfringementsall the tools at his or her disposal to address violations and other concerns with intellectual property.
httpnetically Engineered§ 517. The FDA Commissioner shall consult with the National Oceanic and Atmospheric Administration to produce a report on any
environmental risks associated with any genetically engineered seafood products, including the impact on wild fish stocks.
§ 518. Within 30 days of enactment, the Secretary, in consultation with the Secretary of Commerce, shall submit to the appropriate
eting of Certaincongressional committees a report on the differences between certain species of lobster, which is to describe differences in consumer
ustaceansperception, including taste, quality and value of these species.
ndoor§ 520. Requires the Secretary, acting through the FDA Commissioner, to: make certain determinations regarding the labeling of indoor
nning devices andtanning devices; conduct consumer testing; hold public hearings; and report to Congress within one year of enactment.

in Cancer

TopicS. 1082H.R. 2900
ticounterfeiting Technologies§ 514. Requires (within 18 months of enactment) that the§ 910 in H.R. 2900. Requires the Secretary (in consultation
packaging of any prescription drug incorporate awith other federal agencies, including the Drug Enforcement
standardized numerical identifier unique to each package,Administration, the Department of Homeland Security, and
applied at the point of manufacturing and repackaging.the Department of Commerce) to develop and prioritize
standards and evaluate technologies to secure the
Requires (within 24 months for the 50 prescription drugsdistribution system against prescription drugs that are
with the highest dollar volume of U.S. sales in 2007, andcounterfeit, diverted, subpotent, substandard, adulterated,
within 30 months for all other prescription drugs) thatmisbranded, or expired.
packaging incorporate overt optically variable
counterfeit-resistant technologies, or other technologiesRequires the Secretary: to address radiofrequency
with comparable security function.identification technology, nanotechnology, encryption
technologies, and other track-and-trace technologies; to
iki/CRS-RL34102expand and enhance the resources and facilities of the FDA
g/wOffice of Regulatory Affairs to protect the prescription drug
s.ordistribution system; and to undertake enhanced and joint
leakenforcement activities with other federal agencies and state
://wikiofficials, and establish regional capabilities for validationand inspection.


TopicS. 1082H.R. 2900
en Petition, General ProvisionsS. 1082, Sec. 506; H.R. 2900, Sec. 912. Prohibits the Secretary from delaying the review or approval of generic or
arding the approval of genericabbreviated new drug applications on the basis of a petition that seeks to have the Secretary take, or refrain from taking,
iated new drugactions relating to the application’s approval. Prohibition is excepted when the Secretary determines that a delay is
ications (ANDAs)necessary to protect the public health.
The Secretary must make such public health determinationThere is no time limit for the Secretary’s determination.
not later than 25 business days after the submission of the
The Secretary must post a detailed statement on the FDA
website, providing the reasoning for the determination on
the FDA website, within 5 days after the determination.
iki/CRS-RL34102(Requirements specified).
g/wIf the Secretary determines that the primary purpose of
s.orsubmitting the petition was to delay approval, the Secretary
leakcan deny the petition at any point.
://wikiIf the 180-day marketing exclusivity would be forfeited
httpbecause the applicant failed to obtain tentative approval
status within 30 months (according to (j)(5)(D)(i)(IV)), the
30-month period is extended by the time equal to the time
from when the Secretary received the petition and when a
final agency action on the petition occurred.
en Petition, Notice to ApplicantThe Secretary must give notice of the delay to the applicant...
... within 10 days of the determination. Within this time... in a written explanation. There is no time limit for
the Secretary must also provide the applicant anproviding the explanation. There is no mandatory
opportunity to discuss the determination with appropriateopportunity to discuss the determination.

staff as determined by the Commissioner.

TopicS. 1082H.R. 2900
en Petition, Final Agency ActionThe Secretary must take final agency action not later than 180 days from when the petition was submitted...
... but the Secretary may delay final action if necessary to ... and no extension is possible.
protect the public health.
en Petition, Relationship ofThe Secretary cannot delay approval of such applicationsThe petition must be considered separate and apart from
tition Review and Drug Approvalwhile a petition that seeks to have the Secretary take, orthe review and approval of the application.
refrain from taking, actions relating to the application’s
approval is reviewed and considered.
en Petition, Verifications Specified certifications must be submitted with citizen petitions, verifying their truthfulness under penalty of perjury...
... without which, the Secretary must not accept a petition... without which the Secretary may not consider the petition
iki/CRS-RL34102for review.for review.
g/w Specifies what information must be filled in the blanks (i.e.One required certification states “I have taken reasonable
s.ordate and signature) of the certification.steps to ensure that any representative data and/or
leakinformation which are unfavorable to the petition were
://wikiThe Secretary must not accept for review any supplementaldisclosed to me.”
httpinformation or comments on a petition unless they are in
writing, accompanied by certifications under penalty of
en Petition, Civil ActionIf a civil action is filed with respect to any issue raised in a
petition before a final agency action, the court must dismiss
the action for failure to exhaust administrative remedies.

TopicS. 1082H.R. 2900
en Petition, Annual ReportRequires the Secretary to provide an annual report to Congress that includes the number of generic applications and
ANDAs approved during the preceding 12 months; the number of such applications whose effective dates were delayed
by petitions during that period; and the number of days by which applications were delayed.
The report must also contain: the number of petitions
submitted during that period; the number of application
approvals delayed for public health reasons while petitions
were reviewed (according to (1)(A)(iii)); and the number
of days of the delay.
en Petition, ExceptionsThe subsection does not apply to a petition that is made by the sponsor of the application and that seeks only to have the
Secretary take or refrain from taking action on that application.
iki/CRS-RL34102The subsection does not apply to a petition that relates
g/wsolely to the timing of the approval of an application
s.orpursuant to FDCA § 505(j)(5)(B)(iv).
leaken Petition, ReportsThe Office of Inspector General must issue a reportThe Secretary must submit a report to Congress on ways to
://wikievaluating evidence of the compliance of the FDA with theencourage the early submission of petitions under the
httprequirement that the consideration of petitions that do notprovisions added by § 505(q), as added by H.R. 2900, §
raise public health concerns remain separate and apart912(a).
from the review and approval of a generic drug application
or ANDA.
en Petition, Existing RegulationsNo similar provision.Existing regulations regarding citizen petitions, and
administrative stays of action (21 C.F.R. §§ 10.30, 10.35),
or any successor regulations, apply in addition to this
section’s requirements.
en Petition, DefinitionFor purposes of the subsection, “petition” includes any request to the Secretary for an action (such as a delay in the
effective date of the application). The request need not be characterized as a petition.
This table was created with assistance from Vanessa Burrows, Legislative Attorney, CRS American Law Division.