Direct-to-Consumer Advertising of Prescription Drugs
CRS Report for Congress
of Prescription Drugs
March 25, 2005
Donna U. Vogt
Specialist in Social Legislation
Domestic Social Policy Division
Congressional Research Service ˜ The Library of Congress
Direct-to-Consumer Advertising of Prescription Drugs
The Direct-to-Consumer (DTC) advertising of prescription drugs by
pharmaceutical companies has been described as any promotional effort with respect
to these drugs that targets the general public through the lay media. Spending by the
drug industry on DTC advertising grew from $791 million in 1996 to $3.2 billion in
2003, mostly for promotion of 50 brand-name drugs. There is a growing consensus
among health professionals and others that DTC advertising may have exacerbated
recent problems with drug safety (e.g., Vioxx) and that it may contribute to the rising
cost of health care.
Drug manufacturers claim that DTC advertising reminds patients to visit their
doctors and be tested for health problems earlier, to take their medicines as
prescribed, and to become more involved in their own treatment. Some physicians
acknowledge that DTC advertising serves as an effective tool for conveying health
information to their patients. Others, however, mistrust DTC advertising because,
in their opinion, the information provided by the ads can sometimes be misleading.
From their perspective, DTC ads rarely, if ever, discuss non-drug forms of treatment,
such as weight control and other beneficial lifestyle changes.
In 1962, Congress gave the Food and Drug Administration (FDA) the authority
to regulate prescription drug advertising, which, at the time, consisted primarily of
ads in medical journals directed mostly toward physicians. The law prohibited FDA
from issuing regulations that would require prior approval of the content of drug
advertising. Published regulations require that all drug ads include a “brief
summary” statement that discloses all the drug’s known risks. Because most
commercial advertising is limited in length or duration, drug makers found
compliance with these regulations difficult, particularly in television and radio
advertising. Until 1997, FDA had given no guidance to the drug industry on how
the “brief summary” requirements for broadcast advertising could be met. It then
issued a draft guidance, finalized in 1999, clarifying that it would treat broadcast
advertising differently than print advertising. It stipulated that broadcast ads had to
include the advertised product’s most important risks (called a “major statement” by
FDA) in the audio portion of the advertisement. FDA’s guidance provided that the
DTC ads should give sources where more complete risk information about a drug
would be available (i.e., on Internet sites, toll-free telephone numbers, referral to
health care providers, and large-circulation print sources).
Some Members of Congress are asking whether FDA’s current policies on DTC
ads give consumers information that appropriately balances risks and benefits or
whether ads misrepresent important information patients need prior to purchasing or
consuming the drug. This report examines legislative concerns and options on risk
and health information as they relate to advertising of drugs. It also discusses
activities that could be undertaken with current legislative authority to address
concerns about DTC advertising; and examines options for new statutory authority
on DTC advertising.
This report will be updated periodically.
In troduction ......................................................1
Growth in Spending on DTC Prescription Drug Advertising................2
Effectiveness of Spending on DTC Ads............................3
R & D Spending Versus Promotional Spending......................4
Impact of DTC Advertising..........................................4
Impact on Number of Adverse Events..............................5
Impact on Behavior............................................7
FDA’s Existing Authority to Regulate DTC Advertising..................15
Federal Food, Drug, and Cosmetic Act (FFDCA)....................15
FDA Use of Current Authority......................................16
Guidance for Broadcast Ads....................................17
Draft Guidance for Print Ads....................................18
Brief Summary Guidance...................................18
FDA’s Enforcement Activities...................................20
Risk and Health Information....................................26
Activity Under Current Authority................................27
Pre- and Post-Publication Review............................27
FDA-Mounted Consumer Education..........................27
Increase in FDA-Industry Collaboration.......................28
Increase FDA’s Enforcement Activity.........................29
Additional Activity Requiring New Authority......................29
Increase Compliance and Enforcement Tools...................30
Require Pre-Release Review................................30
Set Limits on Timing and Placement of Ads....................30
Ban DTC Advertising.....................................30
Previously Proposed Legislation.................................31
List of Tables
Table 1. Total U.S. Promotional Spending on Prescription Drugs, 1996-2003..2
Table 2. Drug Companies’ Spending on R&D, Promotional Activities,
and DTC Advertising...........................................4
Table 3. FDA Findings on Patients’ Attitudes and Behaviors Associated
with DTC Promotion of Prescription Drugs.........................9
Table 4. FDA Findings in 2002 on Physicians’ Attitudes and Behaviors
Associated with DTC Promotion of Prescription Drugs...............12
Table 5. Appropriations for CDER’s Division of Drug Marketing, Advertising,
and Communications FY2003, FY2004 (actual), FY2005 (projected),
and FY2006 (requested)........................................24
Table 6. Funding for the CDER’s Office of Drug Safety and Full-Time
Equivalent (FTE) Positions.....................................25
of Prescription Drugs
Direct-to-Consumer (DTC) advertising is usually described as any promotional
effort by pharmaceutical companies to present prescription drug information to the
general public through the lay media.1 DTC advertising shows up in magazines,
newspapers, non-medical journals, pharmacy brochures, and direct-mail letters, and
on television, radio, videos, and Internet websites. Anyone who watches television
or listens to the radio today has likely seen or heard some sort of DTC advertisement
for prescription drugs. The ads usually fall into one of three categories:2
!“Product-claim” ads that include a product’s name and a therapeutic
claim about the product.
!“Help-seeking” ads that discuss a particular disease or health
condition, and advise the consumer to “see your doctor” but do not
mention the product’s name.
!“Reminder” ads that call attention to the product’s name but make
no reference to the health condition the drug is used to treat.
Of these three categories of advertisements, the Food and Drug Administration
(FDA) has the authority to directly regulate only product-claim ads. The regulations
require that therapeutic claims not be false or misleading. The agency regulations
differentiate between print and broadcast DTC product-claim ads. Print ads must
contain all the risk information described in the drug’s FDA-approved label,
including major side effects, contraindications, and precautions. Broadcast
advertisements, however, must directly state only major risk information and must
direct viewers and listeners to other sources from which they can access the complete
Help-seeking ads also are directed toward consumers but make no health claims.
Reminder ads also make no health claims but are primarily directed toward doctors
and health care professionals, who are more likely than consumers to know about the
advertised product and its use. They also serve to acquaint consumers with brand
names of products. Although the agency monitors these two types of ads, to ensure
1 R.G. Frank et al., Prescription Drug Policy Issues in California, report prepared for the
California HealthCare Foundation, Apr. 1999, in Michael S. Wilkes, Robert A. Bell, and
Richard L. Kravitz, “Direct to Consumer Prescription Drug Advertising: Trends, Impact,
and Implications,” Health Affairs, Mar./Apr. 2000. (Hereafter cited as Frank et al.,
Prescription Drug Policy Issues.)
there is no implication of a product claim, it has issued only draft guidance on them
because it does not have the authority to regulate these ads.
This report focuses on the impact of product claim ads and the regulatory
requirements for these ads. This report also discusses FDA’s funding, enforcement
authority and initiatives, “commercial speech” court rulings, previous legislation, and
other relevant agency activities.
Growth in Spending on DTC
Prescription Drug Advertising
Promotion and prescription drug DTC spending has reached significant levels
in recent years. Table 1 shows annual spending since 1996 on DTC advertising,
along with spending on other types of promotional activities by pharmaceutical
Table 1. Total U.S. Promotional Spending
on Prescription Drugs, 1996-2003
(millions of dollars)
Type 1996 1997 1998 1999 2000 2001 2002 2003
Promotion to consumers
DT Ca 791 1,069 1,317 1,848 2,467 2,679 2,638 3,235
Other industry identified promotional activities
Source: IMS Health, Integrated Promotional Services TM and CMR, 6/2004
a. DTC promotion represents the expenditures for direct-to-consumer pharmaceutical advertising for
prescription products on television, magazines and newspapers, on radio and outdoors.
b. Office promotion includes costs associated with sales activities of pharmaceutical representatives
that are directed to office-based physicians (often referred to as “detailing.”)
c. Hospital promotion captures the costs associated with sales activities of pharmaceutical
representatives that are directed to hospital-based physicians and directors of pharmacies.
d. Journal advertising reflects advertising expenditures for prescription products appearing in medical
j o ur na l s .
e. The retail value of the product sampling activities of pharmaceutical representatives are those
directed to office-based physicians, as reported by members of their front office staff.
According to Table 1, spending on DTC advertising of prescription drugs grew
more than quadrupled between 1996 and 2003, rising from $791 million in 1996 to
$3.2 billion in 2003. In 2003, spending on DTC ads constituted approximately 13%
of all promotional spending for pharmaceuticals; when the retail value of samples is
subtracted from the total amount, DTC advertising made up 36% of promotional
spending, second only to the cost of pharmaceutical representatives’ physician-
office sales activities (“detailing”).
One critic claims, however, that the drug companies use many different
marketing methods to influence prescribing decisions of physicians, not all of which
are included in the reported promotional spending (as seen in Table 2) of the drug
industry.3 These activities, she asserts, include educational meetings and luncheons
that the industry provides to doctors, hospitals, and medical schools.4
Effectiveness of Spending on DTC Ads
Studies differ in how advertising effectiveness is measured. According to IMS5
Health, promotional spending has yielded increased sales for at least 49 brand-name
drugs. IMS Health found in its study of “return on investment” in DTC advertising
that at least 90% of the brands demonstrated positive returns; 70% of the brands had
returns in excess of $1.50 for each dollar invested; and 35% were in excess of $2.50.6
The best- performing brand yielded a return of $6.50 per dollar invested. The study
found that 10 of the leading 12 brands had sales of over $1 billion. For these brands,
return on investment was $3.66 per dollar spent compared with slightly more than
one dollar for every dollar spent on brands with sales below $200 million. Other
research has also found a good return for DTC ads. This research suggests “a yield
of an additional $4.20 in sales for every dollar spent on DTC advertising.”7
Pharmaceutical Research and Manufacturers of America (PhRMA), the trade
association representing the major drug manufacturers, believes that advertising,
3 Marcia Angell, The Truth About the Drug Companies: How They Deceive Us and What
to Do About It (New York, Random House, 2004).
4 Ibid. See also comments made by Janet Woodcock, FDA’s Acting Deputy Commissioner
for Operations, that drug companies continue to offer physicians free cruises and stays in
exotic resorts. U.S. Congress, Senate Committee on Health, Education, Labor and Pensions,thst
Ensuring Drug Safety: Where Do We Go from Here? hearings, 109 Cong., 1 sess., Mar.
3, 2005. Comments discussed in Gardiner Harris, “Drug Makers Are Still Giving Gifts to
Doctors, F.D.A. Official Says,” New York Times, Mar. 4, 2005.
5 IMS is a for-profit source for pharmaceutical market intelligence, with operations in more
than 100 countries, employing 6,000 professionals, and with an annual revenue of $1.4
billion. See [http://www.imshealth.com].
6 IMS Management Consulting [David Gascoigne], “DTC at the Crossroads: A ‘Direct’
Hit...or Miss?” IMS Issues and Insights, Sept. 23, 2004, at [http://www.imshealth.com/ims/
portal/front/ar ticleC/ 0,2777,6599_5266_58193110,00.html ].
7 Meredith B. Rosenthal, Ernst R. Berndt, Julie M. Donohue, Arnold M. Epstein, and
Richard G. Frank, Demand Effects of Recent Changes in Prescription Drug Promotion
(Menlo Park, CA: The Kaiser Family Foundation, June 2003), pp. 18-19.
particularly DTC advertising, fosters competition among products which could lead
to lower prices for consumers.8 Other researchers observe, however, that it is unclear
how DTC advertising would lead to lower prices because the point of the ads is to
build consumer loyalty to a specific product whatever its price.9 Decisions on how
pharmaceutical manufacturers set prices and whether they pass the costs of DTC
advertising on to consumers are proprietary.
R & D Spending Versus Promotional Spending
The total amount spent on prescription drug advertising has raised a number of
concerns with some Members of Congress. One such concern is that the drug
industry could be spending more on marketing and promotion than on research and
development, which some see as unacceptable. The drug industry association
disputes that assertion, reporting that R&D spending exceeded promotional spending
every year for the last five years (See Table 2).
Table 2. Drug Companies’ Spending on R&D, Promotional
Activities, and DTC Advertising
(billions of dollars)
Type 1999 2000 2001 2002 2003
Research and development22.726.029.831.033.2
DTC advertising as a % of R&D spending8% 10%9%8%10%
Source: PhRMA, Pharmaceutical Marketing and Promotion, Tough Questions, Straight Answers,
Nov. 2004, [http://www.phrma.org/publications/policy/2004-11-10.1095.pdf].
Impact of DTC Advertising
Federal agencies, consumers, physicians, health care organizations, and industry
groups hold a variety of opinions on the effect of DTC advertising. Hearings in the
fall of 2004 raised questions about the role of DTC advertising in evaluating drug
safety. In November 2004, FDA finalized analysis of three surveys of patients and
physicians (a patient survey in 1999, and two surveys in 2002, one with patients and
the other with physicians). Survey results are discussed below and are summarized
in Tables 3 and 4. FDA found that DTC advertising affects information seeking,
8 Testimony of Gregory J. Glover, representing the Pharmaceutical Research and
Manufacturers of America before the U.S. Congress, Senate Committee on Commerce,
Science, and Transportation, Subcommittee on Consumer Affairs, Foreign Commerce, andthst
Tourism, Prescription Drug Issues, hearings, 107 Cong., 1 sess., July 24, 2001.
(Hereafter cited as Glover, Senate Commerce Committee Testimony, 2001.)
9 Frank et al., Prescription Drug Policy Issues, p. 110.
healthcare visits, questions and/or requests of physicians and ultimately the public
Most DTC advertising targets individuals with chronic health conditions, such
as allergies, stomach ulcers, depression, high blood pressure, and high cholesterol.
Some advertisements target caregivers and family members of those with chronic
conditions, or those who may be at risk of a given disease.10 Ads for osteoporosis
medications, for example, are said to be targeted towards women in their 40s and 50s
who may have some genetic predisposition for the disease. Such ads attempt to
educate patients about different health conditions, and attempt to create a demand for
the drug, in part by increasing interaction between patients and their doctors.
The criteria and discussions leading to company decisions on which medications
to advertise are proprietary. Most of the top selling brand-name products are
extensively advertised, and the advertising increases public awareness of these
Impact on Number of Adverse Events
Recent events have brought FDA’s policies on DTC advertisements into focus
for Congress.12 Some Members have expressed concern about post market problems
with the safety of certain drugs and the potential of causing harm to consumers. The
perceived connection with DTC is that drug companies often use DTC ads to
promote newly approved medications. Although judged safe by FDA with evidence
from clinical trials, these approved drugs had been tested only on a certain number
of patients (5,000 or fewer) and compared almost always with a placebo. With large
10 Ed Slaughter, Corporate Director, Advertising and Trends Research, Rodale, Inc.,
“Seventh Annual Survey: Consumer Reaction to DTC Advertising of Prescription
Medicines,” Prevention Magazine, 2004, pp. 1-7.
12 Hearings in the fall of 2004 looked at whether certain antidepressants heighten suicidal
thoughts and behaviors among children. U.S. Congress, House of Representatives,
Committee on Energy and Commerce, Subcommittee on Oversight and Investigations,
FDA’s Role in Protecting the Public Health: Examining FDA’s Review of Safety andthnd
Efficacy Concerns in Antidepressant Use by Children, hearings, 108 Cong., 2 sess., Sept.
9, 2004. In September 2004, Merck & Co. withdrew its anti-inflammatory medication
Vioxx from the market because studies had shown an elevated heart-attack and stroke risk
with prolonged use. Questions were raised at a November 2004 Senate Finance Committee
hearing about whether earlier studies by the company and others had suggested this risk in
Vioxx. See U.S. Congress, Senate Committee on Finance, FDA, Merck and Vioxx: Puttingthnd
Patient Safety First? hearing, 108 Cong., 2 sess., Nov. 18, 2004. At an FDA advisory
panel meeting, February 16-18, 2005, the members voted for continuing marketing of Vioxx,
Celebrex and Bextra but with stern warnings on the labels of these drugs, severely limited
DTC advertising, and requirements that drug makers provide patients with information
outlining the drugs’ risks. FDA has pledged to consider the advisory panel
recommendations in any regulatory actions the agency may take. However, some groups,
notably Public Citizen, are arguing that all COX-2 drugs (class of drugs to which Vioxx,
Celebrex and Bextra belong) should be removed from the market.
DTC advertising campaigns, many thousands and sometimes millions of people
begin to take the drug.
With this large-scale use, a drug with serious side effects and risks that went
undetected in pre-market trials may cause injury before the problem is recognized.
FDA’s adverse event reporting system, MedWatch, is intended to identify problems
encountered as drugs are used in the wider population and to report this information
back to physicians and medical care personnel. It is, however, a passive surveillance
system, gathering anecdotal and often incomplete information from physicians and
consumers.13 Some in Congress, therefore, are wondering whether the MedWatch
system is doing its job as well as it might. In addition some question whether the
system for dispersing information on problems is reaching the medical professions
in a timely manner.14
Others are concerned that DTC ads minimize the risks of certain medications
while promoting the benefits. Critics say that some patients, taking these DTC
heavily promoted drugs, could use other medications with fewer side effects for
which there are more established health track records.15 But drug industry
representatives claim that prior to FDA’s approval the drugs have been studied and
proven safe with clinical trials and that they are safe under the labeled conditions of
On December 17, 2004, FDA asked Pfizer, Inc. to voluntarily suspend DTC
advertising on Celebrex (one of a class of anti-inflammatory drugs potentially linked
to heart disease) while the agency obtains and evaluates new and conflicting
scientific data on adverse events associated with the drug.16 Pfizer agreed to stop its
advertising. FDA also requested that the company change the information provided
to physicians to reflect the recommendations FDA made encouraging physicians to
consider alternative therapies as they evaluate their individual patients’ needs.
13 Because the MedWatch system provides a count of events without giving the total number
of users, it is difficult to obtain systematic assessments of experience with prescription drugs
following trials and FDA approval.
14 CRS Report RL32797, Drug Safety and Effectiveness: Issues and Action Options After
FDA Approval, by Susan Thaul.
15 “[O]verall harm from a new pharmaceutical may be increased when rapid expansion of
prescribing occurs prior to the development of definitive data on safety. With new drugs
whose safety profile is not well characterized, greater regulatory efforts to limit the use of
the drug to the clinical population in which an unambiguous outcome benefit exists may
minimize the potential for overall public harm,” Carolanne Dai, Randall S. Stafford, and G.
Caleb Alexander, “National Trends in Cyclooxygenase-2 Inhibitor Use Since Market
Release: Nonselective Diffusion of a Selectively Cost-effective Innovation,” Archives of
Internal Medicine, vol. 165 (2005), pp. 171-177, at [http://archinte.ama-assn.org/current.dtl].
16 “[T]he impact of marketing and promotional efforts must also be considered. COX-2
inhibitors have been heavily promoted both through direct-to-consumer advertising as well
as to physicians.” Ibid. See also Food and Drug Administration, “FDA Statement on
Celebrex DTC Promotion,” Dec. 20, 2004, at [http://www.fda.gov/bbs/topics/news/
Impact on Behavior
Two government agencies have stated that competition gives drug companies
an incentive to deliver truthful and accurate information to consumers. Their studies
confirm that DTC advertising is a powerful tool communicating health and wellness
information to consumers that can change people’s behavior. They claim, “good
information is a necessary building block for both consumer empowerment and
enhanced health.”17 However, one critic claims that it is impossible to separate what
is the educational component of an advertisement from the marketing component
because it is all marketing.18 The title of a New England Journal of Medicine
perspectives piece — “To Inform or Persuade?” — describes the dilemma.19
Consumer View. FDA conducted two national patient telephone surveys (one20
in 1999 and the other in 2002) to find out what patients thought of DTC advertising.
The results are summarized in Table 3. Most patients (81%) were aware of ads and
that the ads contained both benefit and risk information. The ads prompted 43% of
respondents to look for more information about a drug or medical condition. Almost
about 40% from reference books and 38% from friends, relatives, and neighbors.
The survey indicated that fewer people in 2002 (18%) asked their physician about
previously untreated conditions than in 1999 (27%). In the 2002 survey, fewer
consumers held positive views of DTC ads than they had in 1999.
The results of FDA’s surveys showed that the proliferation of DTC advertising
has led many patients to become aware of newly available medical treatments for
certain health conditions, and that patients are motivated to ask better questions of
the healthcare provider. Some pharmaceutical companies call their messages
“educational” and claim that DTC ads encourage patients to seek medical advice for
conditions that sometimes go untreated.21 For example, urinary incontinence and
erectile dysfunction advertising brought these two apparently under-diagnosed and
under-treated conditions to consumer attention. As such, these ads can lead to better
17 The Federal Trade Commission regulates the advertising of all consumer products other
than prescription drugs. U.S. Department of Justice and the Federal Trade Commission,
Improving Health Care: A Dose of Competition, July 2004, p. 20, at [http://www.usdoj.gov/
18 Marcia Angell, The Truth About the Drug Companies: How They Deceive Us and What
to Do About It (New York, Random House, 2004).
19 Ernst R. Berndt, “To Inform or Persuade? Direct-to-Consumer Advertising of
Prescription Drugs,” New England Journal of Medicine, vol. 352, no. 4 (Jan. 27, 2005), pp.
20 For the 1999 survey, the response rate out of 960 patients was 65%. For the 2002 survey,
the response rate for 944 people was 53%.
21 IMS Management Consulting [David Gascoigne], “DTC at the Crossroads: A ‘Direct’
Hit...or Miss?” IMS Issues and Insights, Sept. 23, 2004, p. 2.
patient-physician discussions, leading to, for example, life-style changes that could
be beneficial to their health (e.g., losing weight), independent of new drug use.22
The patient survey data provided limited evidence of increased visits to
physicians as a result of DTC advertising.23 Most people reported that health reasons
prompted their visits to physicians. DTC ads can improve patient compliance with
physician advice, the surveys found, particularly if physicians remind patients to take
the medication as prescribed. These ads also have spurred patients to seek
information about a given disease from sources other than their physicians.
FDA’s patient surveys also showed patients had some negative reactions to DTC
advertising. Patients felt that the ads can overstate drug efficacy and do not present
a balance of benefit and risk information. Patients gave only modest ratings to the
information that was meant to provide a more complete picture of the drug product’s
risk. In the 2002 survey versus the 1999 survey, fewer found DTC ads useful in
conversations with their physicians and with healthcare decision making.
However, some ads also may encourage consumers to believe a common health
problem can easily be fixed by a prescription drug. In fact, FDA’s Center for Drug
Evaluation and Research (CDER) Director has discussed what she calls the
“medicalizing of health” by saying that some believe, due to DTC advertising, that
“all aches should be treated with some pill.”24 The concern is that some people who
have managed a small health problem with over-the-counter medications, for
instance, are now pressing physicians to provide prescription drugs. The process may
expose some people to harmful side effects of drugs that may not necessarily be
needed. Other findings are summarized in Table 3.
22 Wendy Borow, “The AMA Explains Its About-face on Direct-to-Consumer Advertising,”
Medical and Marketing & Media, Sept. 1993, p. 68-74.
23 Kathryn J. Aikin, John L. Swasy, and Amie C. Braman, “Patient and Physician Attitudes
and Behaviors Associated with DTC Promotion of Prescription Drugs: Summary of FDA
Survey Research Results,” Final Report, U.S. Department of Health and Human Services,
Food and Drug Administration, Center for Drug Evaluation and Research, Nov. 19, 2004.
24 Comments made by Janet Woodcock, Director of the Center for Drug Evaluation and
Research, at a public meeting titled “Research on Consumer Directed Advertising,” given
by the U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Sept.
Table 3. FDA Findings on Patients’ Attitudes and Behaviors
Associated with DTC Promotion of Prescription Drugs
Category of information1999 survey results a2002 survey results
Visits to healthcare providerNot asked.4% of patients surveyed who had visited
their doctor had done so because of an ad.
Generation of questionsAbout 33% of patients said DTC had generated questions for their physician;
33% said friends and family generated questions; and 20% reported reference
books sparked questions.
Expectations about42% of patients expected a prescription at the most recent doctor’s visit; of
receiving Rxthese, 63% expected a refill, 17% were sick, and 6% had seen a television ad and
5% had seen a magazine ad that kindled the expectation.
Asking behaviors32% of patients asked if any drug were available. Of these, 39% asked about a
specific brand. Over 90% reported that their physicians welcomed questions.
Prescribing response50% of patients reported getting a prescription for drug asked about. 33% got
a different drug and 41% were told to change behavior or diet. Patients who
asked for a specific named drug were more likely to get a prescription for that
drug than patients who did not ask about a specific drug.
Patient opinions about DTC86% of patients agree that ads77% of patients agree that ads increase
advertisingincrease awareness of newawareness of new drugs; 58% felt ads provide
drugs; 70% felt ads provideenough information to decide whether to
enough information to discussdiscuss with physician; 39% thought ads
with physician; 60% say ads doencourage patients to seek more information
not provide enough riskabout potentially serious medical conditions.
information and 44% say adsAs in 1999, 60% say ads do not provide
lack benefit information.enough risk information and 44% say ads
lack adequate benefit information.
Influence on relationship62% of patients felt ads led to73% of patients agreed that ads do not
with healthcare provider better discussions with doctor;minimize physicians’ role in product
7% of patients were reluctant todecisions; 43% said ads helped in discussions
discuss advertised drug for fearwith physicians; 10% of patients were
of implying mistrust of doctor.reluctant to discuss advertised drug for fear of
implying mistrust of the physician.
Overstatement of benefitsNot asked.58% of patients said ads portray products as
better than they are; 42% felt ads make it
seem that the product would work for
Effects on own health47% of patients felt ads help32% of patients felt ads help them make
them make better healthbetter health decisions; 18% said ads
decisions. No other questionsreminded them to take medicines; 17% said
were asked.ads caused anxiety about health.
General attitudes52% of patients reported they32% of patients reported they liked seeing
liked seeing DTC ads.DTC ads.
Understanding the BriefNot asked.78% of those interested read all or most of
Summary risk informationthe main ad; 45% of patients read most or all
of the risk details in the Brief Summary when
interested in the drug; 50% of those who read
some of the Brief Summary said it was
difficult to read.
Cost issues40% of patient respondents never discuss the cost of drugs with their doctors;
16% discuss it frequently. Most likely to discuss cost with their physicians were
female patients in poor health taking prescription drugs and lacking drug
Source: Kathryn J. Aikin, John L. Swasy, and Amie C. Braman, “Patient and Physician Attitudes and
Behaviors Associated with DTC Promotion of Prescription Drugs: Summary of FDA Survey Research
Results,” Final Report, U.S. Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, Nov. 19, 2004.
a. Where percentages stayed relatively the same in both the 1999 and 2002 surveys, results are
presented as one.
Several other surveys added other perspectives to the issue. For example, a
survey by the magazine Prevention found that even with the pervasiveness of DTC
advertising in magazines and on television and with the tremendous increase in
spending on DTC ads, patients’ requests of their physicians for or about advertised
drugs has remained stable at about 8%. The author concludes that the ads “can’t
overcome Americans’ desire to avoid taking prescription drugs.”25 However, this
survey also showed that about 7% of people surveyed asked for and received a
prescription drug because of DTC advertising and 7% stopped taking a drug after
seeing it advertised. It also established that a positive public health response to the
advertising was that patients seek information about health conditions for themselves
or for people in their care. This same survey states that “consumers are three times
more likely to search for information about medicines family members or friends are26
already taking, than they are to ask their doctors for medicines for themselves.”
Another study conducted by several Harvard professors found a portion of
patients visits that were spurred by DTC ads were for clinically important conditions27
that resulted in a new diagnosis. Their study did not detect widespread adverse
effects of DTC ads on people’s health. This study also found that consumers can
gain extra benefits not limited to the advertised drug because they get supplementary
information about their health.
Physician View. Some physicians believe that DTC advertising serves as an
effective tool for providing health information to consumers. Some believe that DTC
advertising is one reason patients are visiting their doctors more, undergoing tests to
catch health problems earlier, taking their medicines regularly, and getting more
involved in their own treatment. However, some physicians mistrust DTC
advertising because, in their opinion, the ads often promote a view of medicine that
is misleading. Some say that the information presented in DTC ads obscures
information about a drug’s risks.28 Less expensive drugs can often work as well as
25 Ed Slaughter, Corporate Director, Advertising and Trends Research, Rodale, Inc.,
“Seventh Annual Survey: Consumer Reaction to DTC Advertising of Prescription
Medicines,” Prevention Magazine, 2004, p. 7.
26 Ibid., p. 60.
27 Joel S. Weissman, David Blumenthal, Alvin J. Silk, Kinga Zapert, Michael Newman, and
Robert Leitman, “Consumers’ Reports on the Health Effects of Direct-to-Consumer Drug
Advertising,” Health Affairs — Web Exclusive, Feb. 26, 2003, p. W3-82 to W3-95.
28 Council on Ethical and Judicial Affairs of the American Medical Association, “Direct-to-
Consumer Advertisements of Prescription Drugs,” Food and Drug Law Journal, vol. 55,
the advertised drugs,29 and some claim that DTC advertising can give the false
impression to consumers that prescription drugs are just like any other commercial
product — soap, cars, cereal, snacks — and that patients only need a specific pill to
fix whatever ails them.30 This attitude, some say, could contribute to an
unwillingness on the part of the patient to make needed lifestyle changes. DTC ads
rarely, if ever, discuss non-drug forms of treatment.
In 2002, FDA questioned office-based physicians about the role of DTC in
influencing their practices and relationships with their patients. Table 4 summarizes
the agency’s presentation of the survey’s findings. Out of a sample of 250 primary
care physicians and 250 specialists chosen randomly from the American Medical
Association (AMA) master file, 46% responded. Physicians, particularly primary
care physicians, noted an increase in questions about prescription drug treatments
with 85% saying patients asked often or all the time, and 62% reported patients asked
frequently about generic drugs. They also described benefits and problems that
arose. Most physicians reported being comfortable with denying medications
particularly when the requested drug is not right for the patient. Ninety-three percent
of physicians welcomed questions about specific drugs from patients, and between
74% and 77% of the doctors prescribed the requested drug when a specific drug was
29 National Institute for Health Care Management (NIHCM) Foundation. Factors Affecting
the Growth of Prescription Drug Expenditures. Prepared by Barents Group LLC, July 9,
30 Ibid., p. 7.
31 Kathryn J. Aikin, John L. Swasy, and Amie C. Braman, “Patient and Physician Attitudes
and Behaviors Associated with DTC Promotion of Prescription Drugs: Summary of FDA
Survey Research Results,” Final Report, U.S. Department of Health and Human Services,
Food and Drug Administration, Center for Drug Evaluation and Research, Nov. 19, 2004.
Table 4. FDA Findings in 2002 on Physicians’ Attitudes and
Behaviors Associated with DTC Promotion of Prescription
Category of information2002 survey responses
Benefits and problems of patient41% of physicians thought exposure was beneficial, leading
DTC exposureto better discussions, greater awareness of treatments, and that
DTC was a source for informing patients. 18% said exposure
led to problems such as misconceptions, requiring physician
correction, requests for unnecessary drugs, and requests for
one medication when another treatment was effective. 73%
said patients asked thoughtful questions because of DTC
exposure. 41% of physicians said patients were confused
about drugs effectiveness because of the DTC ad.
Patient drug requesting behaviorThe survey distinguished between patients asking if there
were a drug to treat a specific problem and those asking for a
specific drug. 86% of physicians recalled patients asking
about a drug and 88% of them said that the patient had the
condition the drug treats. 77% of primary care physicians
prescribed the requested drug whereas 74% of specialists did.
Denial of requestsMost frequent reason given by physicians for denial was that
the drug was not right for the patient and another drug was
more appropriate. Primary care physicians denied
prescriptions for a variety of reasons: because there was a less
expensive drug available, no prescription was required, or
patient could engage in behavioral or diet changes.
Specialists declined prescriptions because a different drug was
appropriate, a drug was not right for patient, or the drug had
side effects unknown to the patient.
Pressure to prescribe50% of physicians reported no pressure, and 91% reported a
patient did not try to influence treatment that would have been
harmful to patient. 22% of primary care physicians felt
“somewhat” or “very pressured” to prescribe; 13% of
specialists felt that way. 73% of primary care physicians
reported patients came to the appointment expecting a
prescription versus 63% of specialists. Primary care
physicians were more likely to say this influenced their
General opinions about patientPhysicians thought that 75% of patients understood that drugs
understanding of DTC advertisingare available only with a prescription, 82% knew that only a
physician could make the decision about appropriateness, and
78% understood the drug’s benefits. Between 40%-50%
believed patients understood the risks and possible negative
effects of drugs, 30% understood the limits of drug efficacy,
and 25% were the type of person who should avoid drugs.
Opinions about problems65% of physicians felt patients confuse the relative risks and
benefits of DTC advertised drugs and 75% felt that ads led
patients to overestimate the efficacy of the drugs. 38%
believed DTC ads caused patients to question their diagnoses,
and 28% said that ads led to tension in the doctor-patient
r e latio nship .
Category of information2002 survey responses
Opinions about benefits72% of the physicians think DTC ads increase awareness of
possible treatments, 44% believe that ads facilitate earlier
awareness of health conditions. About 33% think DTC ads
increase the likelihood of proper medication usage, and 33%
believe ads help patients maintain treatment.
Overall impressions of influence33% of physicians said that DTC ads had positive effect; 33%
of DTC advertising on patientssaid ads had a negative effect; and 33% said the ads had no
and practiceeffect at all. 38% of primary care and 27% of specialists rated
DTC advertising as having a somewhat or very negative effect
on their patients and practice.
Source: Kathryn J. Aikin, John L. Swasy, and Amie C. Braman, “Patient and Physician Attitudes and
Behaviors Associated with DTC Promotion of Prescription Drugs: Summary of FDA Survey
Reseearch Results,” Final Report, U.S. Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, Nov. 19, 2004.
Industry View. Drug companies rely on DTC advertising to stimulate demand
and to increase sales for pharmaceuticals.32 The drug industry claims that DTC ads
have increased consumer awareness that all prescription drugs have risks and side
effects; that non-drug approaches exist to improve health; and that advertisements
remind and motivate consumers to comply better with drug therapy regimes.33
According to the pharmaceutical industry, the increase in prescription drug use and
spending appears to be the result of several different factors, and not necessarily
attributable to DTC advertising: a significantly greater number of prescriptions being
written for an aging population to restore and/or maintain health; a shift in
prescriptions to newer higher cost drugs; new standards of medical practice
encouraging greater use of drugs; more treatment of previously untreated patients;
and a greater attention to preventing and managing disease resulting in net savings
at times compared with spending in hospitals.34 In addition, if more people take a
specific drug or the same number of people are using the drug but more frequently
(staying compliant), the total amount of what is spent on the drug will also increase.35
As discussed earlier, economists have stated that recent growth in DTC
advertising has increased the demand for well-publicized drugs because, as people
learn of alternative therapies, consumers may request newer, higher-priced drugs in
32 Glover, Senate Commerce Committee Testimony, 2001, p. 5.
33 Testimony of Senior Assistant General Counsel Marjorie E. Powell, Pharmaceutical
Research and Manufacturers of America before the U.S. Congress, Senate Special
Committee on Aging, Direct to Consumer Advertising: What are the Consequences?,thst
hearings, 108 Cong., 1 sess., July 22, 2003.
34 Ibid., pp. 11-12.
35 Geoffrey F. Joyce, Jose J. Escarce, Matthew D. Solomon, and Dana P. Goldman,
“Employer Drug Benefit Plans and Spending on Prescription Drugs,” JAMA, vol. 288, no.
14 (Oct. 9, 2002), pp. 1733-1739. Increasing co-payments for prescription drugs and
requiring mandatory generic substitution reduced overall drug spending among working age
enrollees with employer-provided drug coverage.
place of less expensive ones, thereby increasing health care costs.36 Whether that
substitution is medically necessary is another issue. However, one physician
testifying before the Senate Special Committee on Aging concluded that DTC
advertising can drive the spending on pharmaceuticals but is responsible for only a
small share of the total growth in spending on drugs, referring instead to other factors
Studies sponsored by both industry and academic researchers suggest that the
ads can lead to cost-effective treatments in some circumstances.38 For example,
many experts find that although “statin” drugs lower blood cholesterol levels and are
relatively cost-effective as secondary prevention in persons with existing heart
disease, they are much less cost-effective than primary prevention such as weight
control and exercise.39
A spokesman for the pharmaceutical industry in testimony before Congress
stated that medicines are the “most cost effective form of health care” because they
can keep patients out of hospitals and nursing homes and avoid surgery.40 He quoted
a National Institutes of Health study which found that clot-busting drugs used to treat
stroke patients save, on average, $4,300 a year per patient by reducing the need for
hospitalization, rehabilitation, and nursing-home care.41 However, others, who have
researched cost-effectiveness of pharmaceuticals, say that the question of whether
drugs are cost effective “depends critically on the context in which the drug is used
and the intervention to which it is being compared.”42
36 Stephen Heffler, Katherine Levit, Sheila Smith, Cynthia Smith, Cathy Cowan, Helen
Lazenby, and Mark Freeland, “Health Spending Growth Up in 1999; Faster Growth
Expected in the Future,” Health Affairs, vol. 20, no. 2 (Mar./Apr. 2001), p. 198.
37 Testimony of Meredith B. Rosenthal in U.S. Congress, Senate Special Committee on
Aging, Direct to Consumer Advertising: What are the Consequences? hearing, 108th Cong.,st
38 Frank Lichtenberg, Benefits and Costs of Newer Drugs: An Update, Working Paper 8996.
National Bureau of Economic Research, June 2002 at [http://www.nber.org/papers/w8996].
39 Peter J. Neumann, Eileen A. Sandberg, Chaim M. Bell, Patricia W. Stone, and Richard
H. Chapman, “Are Pharmaceuticals Cost-Effective? A Review of the Evidence,” Health
Affairs, vol. 19, no. 2 (Mar./Apr. 2000), pp. 97 and 99 (Hereafter cited as Neumann et al.,
“Are Pharmaceuticals Cost-Effective?”) Cited examples of successful interventions that
produce health benefits for relatively little cost or save money for the health care system are:
warfarin therapy to prevent stroke in patients with atrial fibrillation, immunosuppressive
drugs for those with kidney transplants, and treatment with mood-altering drugs for some
people with depression.
40 Glover, Senate Commerce Committee Testimony, 2001
41 S.C. Fagan, L.B. Morgenstern, A. Petitta, R.E.Ward, B.C. Tilley, J.R. Marler, S.R.
Levine, J.P. Broderick, T.G. Kwiatkowski, M. Frankel, T.G. Brott, M.D. Walker, and the
NINDS rt-PA Stroke Study Group, “Cost-Effectiveness of Tissue Plasminogen Activator for
Acute Ischemic Stroke,” Neurology, vol. 50 (Apr. 1998), pp. 883-890.
42 Neumann et al., “Are Pharmaceuticals Cost-Effective?” p. 104.
Other critics claim that there is no scientific evidence that DTC ads educate the
public about illnesses or new medicines, or that they encourage physician visits.
Rather, some observers, such as Arnold S. Relman, emeritus editor-in-chief of the
New England Journal of Medicine, say that those assertions are made by salespeople
whose sales have increased due to these ads.43 One research group has looked at how
consumers and physicians report DTC advertising’s effect. It reported that patient
visits to physicians promoted by DTC ads did not necessarily result in a prescription
for the advertised drug.44 The authors commented that consumers benefit when they
visit physicians about a particular drug because many visits resulted in new diagnoses
such as “high cholesterol, hypertension, diabetes, and depression, health conditions
often underdiagnosed and undertreated in the general population.”45 The authors
note, however, as did Dr. Relman in testimony before the Senate Special Committee
on Aging, that these interview studies were not designed to determine whether ads
were misleading, caused patients to receive more expensive drugs than necessary, or
increased the cost of health care. Neither could these studies determine whether
other sources of public information could achieve the educational benefits of DTC
at lower cost.
FDA’s Existing Authority to Regulate
The following sections describe the statutory basis for current regulation of DTC
advertisements, recent FDA actions and funding.
Federal Food, Drug, and Cosmetic Act (FFDCA)
The FFDCA sets forth the statutory requirements that pharmaceuticals must
meet before they can be approved for marketing in the United States. Since 1938,
Section 201 of the Act gives the FDA broad authority to consider drugs misbranded
if their labeling or advertising is false or misleading in any way. At the time,
advertising was primarily printed material directed towards physicians. In 1962,
Congress added Section 502(n) to the Act, to give the FDA the authority to regulate
prescription drug promotional labeling and advertising, including DTC
advertisements.46 In the same section, Congress prohibited FDA from issuing any
regulations that would require prior approval of the content of any advertisement.
43 Testimony of Arnold S. Relman, in U.S. Congress, Senate Special Committee on Aging,
Direct to Consumer Advertising: What Are the Consequences? hearing, 108th Cong., 1st
sess., July 22, 2003.
44 Joel S. Weissman, David Blumenthal, Alvin J. Silk, Michael Newman, Kinga Zapert,
Robert Leitman, and Sandra Feibelmann, “Physicians Report on Patient Encounters
Involving Direct-to-Consumer Advertising,” Health Affairs — Web Exclusive, Apr. 28,
45 Joel S. Weissman, David Blumenthal, Alvin J. Silk, Kinga Zapert, Michael Newman, and
Robert Leitman, “Consumers’ Reports on the Health Effects of Direct-to-Consumer Drug
Advertising,” Health Affairs — Web Exclusive, Feb. 26, 2003, pp. W3-82 to W3-95.
46 21 U.S.C. § 502 (n).
In 1969, FDA issued final
regulations governing drugDifferences between labeling and advertising
advertising at 21 C.F.R.FDA considers promotional material and
§ 202.1.47 Under theseadvertising to be different from approved product
regulations, advertisements mustlabeling. FDA must approve the wording of a
have four basic attributes: (1)drug’s approved product labeling before the
they cannot be false orproduct can be marketed. Labeling generally
misleading; (2) they mustincludes the drug’s known significant side effects
present a “fair balance” of(both those serious and those not serious but
information about the risks andfrequently occurring). It uses technical language
benefits of using the drug; (3)since the information it conveys is mostly targeted
they must contain “facts” thatat health care professionals. While FDA does have
are “material” to the product’sauthority for approving labeling, it does not, asnoted, have authority to require the pre-approval
advertised uses; and (4) inof any promotional materials or advertising,
general, the advertisement’sincluding DTC advertising.
“brief summary” of the drug
must include every risk from the
product’s approved labeling. The regulations require that companies submit
promotional materials to FDA at the same time they make them available to the
public.48 The promotion within these materials must be supported by scientific
evidence and be consistent with FDA-approved product labeling. The ads can be the
approved labeling or other promotional materials, but must not recommend or
suggest any use of a drug that is not listed in the approved drug’s labeling. (See text
box.) Only uses approved by FDA can be listed on the label or in advertising.
FDA Use of Current Authority
Monitoring compliance and enforcement of DTC advertising regulations is the
responsibility of FDA’s Division of Drug Marketing, Advertising, and
Communications (DDMAC), a division within the Center for Drug Evaluation and
Research. Most drug manufacturers voluntarily submit draft materials to FDA for
review and comment prior to some of their ads being aired on TV and radio.49 In
fact, some drug manufacturers ask for comments at all stages of their broadcast ad’s
preparation. The agency pays particular attention to final broadcast videotapes
47 Jane E. Henney, “Challenges in Regulating Direct-to-Consumer Advertising,”MSJAMA
Report, vol. 284 (Nov. 1, 2000), p. 2242.
48 21 C.F.R. § 314.81(b)(3)(i)states: “The applicant shall submit specimens of mailing
pieces and any other labeling at the time of initial dissemination of the labeling and at the
time of initial publication of the advertisement for a prescription drug product.”
49 See 21 C.F.R. § 314.81(b)(3)(i). According to an FDA official, pharmaceutical companies
often voluntarily ask for agency comments on their proposed ads to ensure that, prior to
airing, the ads will meet FDA’s requirements, because of the expense of these ads. If it
needs to, the agency can take enforcement actions but only after an ad is made public.
because these ads can make or imply inappropriate claims just by their non-verbal
and visual presentations.
Guidance for Broadcast Ads
With respect to TV and radio ads, until 1997, it was unclear how to comply with
the law for, if a product-claim print advertisement mentioned the name of the
prescription drug and its intended medical indications, it had to include all the
information about side effects, contraindications, and precautions from the product’s50
approved labeling. For the most part, conveying all of a product’s risk information
in print advertising is not difficult. However, because commercial broadcast
advertisements are often of limited length (30 to 60 seconds), to include this kind of
detailed information in television and/or radio advertising was thought by the drug51
industry to be too cumbersome and expensive. Although the regulations allowed
for an alternative to presenting every risk in a broadcast advertisement, prior to 1997,
FDA had not issued any interpretation of how broadcast advertisements could fulfill
the “adequate provision” regulation which is an alternative to presenting all the risk52
information in the brief summary. The industry reportedly assumed that FDA
expected broadcast DTC advertising to meet the same requirements as ads in print.53
In August 1997, FDA issued draft guidance on how pharmaceutical companies
fulfill the existing regulatory requirements for advertising prescription drugs on radio
and television. The draft guidance was finalized, without major change, in August54
1999. The guidance provided that DTC broadcast advertisements had to include
the advertised product’s most important risks (called a “major statement” by FDA).
The major statement was required to be in the audio portion of the advertisement, but
could be in the video portion as well. The agency explained that the regulations had
always allowed for broadcast advertisements to either include all the drug’s risks or
ensure that consumers would have “adequate provision” of an advertised product’s
approved labeling. The guidance provides one way to ensure that consumers with
different information-seeking needs and capabilities have adequate access to the
product labeling by disclosing four different sources of this information. These
sources,55 which were to be broadly disseminated to the general public, must include:
50 See [http://www.fda.gov/cder/guidance/index.htm].
51 Pharmaceutical Research and Manufacturers Association, Direct-to-Consumer
Advertising: Backgrounders and Facts (2000).
52 21 C.F.R. § 202.1(e)1.
53 Wayne L. Pines, “A History and Perspective on Direct-to-Consumer Promotion,” Food
and Drug Law Journal, vol. 54, no. 4 (1999), pp. 489-518.
54 The only significant change in the final guidance was the clarification of FDA’s thinking
that its guidance on broadcast DTC advertising could also be used for telephone
advertisements. 64 Federal Register 43197 (Aug. 9, 1999), at [http://www.fda.gov/cder/
55 FDA, Center for Drug Evaluation and Research, Intra-Agency Group on Advertising and
Promotion. Questions and Answers on the Consumer-Directed Broadcast Advertisements
Guidance, June 8, 2000, [http://www.fda.gov/cder/guidance/1804q&a.htm].
Internet sites,56 toll-free telephone numbers, referral to health care providers, and
other print sources with large circulations.57
Draft Guidance for Print Ads
In January 2004, FDA issued three draft guidances: Brief Summary: Disclosing
Risk Information in Consumer-Directed Print Advertisements (brief summary
guidance),”Help-Seeking” and Other Disease Awareness Communications by or on
Behalf of Drug and Device Firms (disease awareness guidance), and a third on
medical device advertising (which will not be discussed here).58 All the guidances
attempt to improve the information that consumers and health care practitioners
receive in advertising about prescription drugs and devices. They also require drug
and medical device firms to disseminate truthful, non-misleading, scientifically
accurate information on medical products and health conditions to consumers and
health care practitioners.
Brief Summary Guidance. FDA requires that any prescription drug
advertisement contain “information in brief summary relating to the side effects,
contraindications, and effectiveness” of the drug.59 The information on the risks of
the product (known as the brief summary) must disclose all the risk-related
information in the drug’s package labeling. So ads in print often include the entire
section of the approved professional labeling with its side-effects and warnings.
FDA has been concerned that the technical language and volume of material
presented discourage consumers from using the information. The agency has now
proposed in its 2004 draft guidance60 that manufacturers choose among three options
(other than printing the entire professional labeling) to satisfy the brief summary
requirement for DTC print ads. All would require that the manufacturer print all
contraindications; all warnings; the major precautions, including any that describe
serious adverse drug experiences or steps to be taken to avoid such experiences; and
the three to five most common nonserious adverse reactions most likely to affect the
patient’s quality of life or compliance with drug therapy.61 What would vary is how
the manufacturer could present that information. The first option would be to reprint
56 Alex Frangos, Special Report: E-Commerce; Prescription for Change, Wall Street Journal,
Apr. 23, 2001. Web-based sites, whether third-party or proprietary, usually contain a link
to a site that advertises one company’s product. Experts suggest that the line between
information and promotion has been blurred.
57 64 Federal Register 43197 (Aug. 9, 1999); see also Council on Ethical and Judicial
Affairs of the American Medical Association, “Direct-to-Consumer Advertisements of
Prescription Drugs,” Food and Drug Law Journal, vol. 55 (2000), p. 120.
58 Draft Device Broadcast Advertising Guidance would apply the same, less burdensome,
brief summary requirement to DTC broadcast ads for restricted medical devices.
59 21 U.S.C. § 352(n).
60 FDA, “[DRAFT] Guidance for Industry: Brief Summary: Disclosing Risk Information
in Consumer-Directed Print Advertisements, Division of Drug Marketing, Advertising, and
Communications,” CDER, Jan. 2004, at [http://www.fda.gov/cder/guidance/5669dft.pdf].
the FDA-approved patient labeling in full.62 For the second option, the manufacturer
could print a portion of the patient labeling, including the risk information but
omitting, for example, directions for use. The third option relates to a proposed
“highlights” section of the professional labeling.63 But because this highlights
section would be written for medical professionals, FDA recommends in the brief
summary guidance draft that it be rewritten to be understandable to consumers.
The agency has asked drug firms to consider the costs and benefits of each of
these options and decide which option is best. Supporters say that less type and
lower information volume will mean lower advertising costs, and consumer oriented
risk information will mean that the information is more useful. Critics argue that this
approach may be appropriate for only a small subset of products. They also argue
that FDA should be going further in developing guidelines for the kind of risk
disclosures that actually allow patients to use them as a basis for further discussion
with a health professional.64 After reviewing the three January 2004 draft guidance
documents at FDA’s request, Federal Trade Commission staff agreed that presenting
risk information in more accessible language would be better than reprinting the brief
summary. The FTC report recommended, however, that FDA conduct consumer
research to assess the various types of risk presentation, the influence on industry’s
advertising incentives, and other costs and benefits of the proposed formats and
others to “determine ... the most effective means of providing drug risk information
in DTC print ads.”65
Disease-Awareness Guidance. The agency clarifies in this guidance when
it does and does not have jurisdiction over help-seeking ads that encourage
consumers to seek treatment for a medical condition.66 The draft “Disease
62 This could be the Patient Package Insert (PPI), special patient materials that FDA
approves that are used to instruct patients about the safe use of the prescription product in
simple, easily understood language. These materials may be given to patients by their health
care provider or pharmacist and are part of FDA-regulated product labeling. They are based
on the approved labeling of the drug.
63 FDA, “[DRAFT] Guidance for Industry: Content and Format of the Adverse Reactions
Section of Labeling for Human Prescription Drugs and Biologics,” May 2000, at
[ ht t p: / / www.f da.gov/ cder / gui dance/ 1888df t .pdf ] .
64 Rosemary C. Harold and John F. Kamp, “Grounding Regulations in Behavior Science:
Strengthening FDA’s Approach to DTC Risk Disclosures,” Update, Food and Drug Law,
Regulation, and Education, no. 6 (Nov./Dec. 2004), pp. 8-12.
65 Federal Trade Commission, “In the Matter of Request for Comments on Agency Draft
Guidance Documents Regarding Consumer-Directed Promotion,” Docket No. 2004D-0042.
May 10, 2004, at [http://www.ftc.gov/os/2004/05/040512dtcdrugscomment.pdf]; and FTC,
“FTC Staff Provides Comments to FDA on Direct-to-Consumer Drug and Device Ads,”
FTC: For the Consumer, May 12, 2004, at [http://www.ftc.gov/opa/2004/05/dtcdrugs.htm].
66 The Federal Trade Commission has jurisdiction over these types of communications and
could investigate and challenge ads if they appeared to be “unfair or deceptive acts or
practices” (15 U.S.C. § 45, in general; 15 U.S.C. § 52, specific application to drugs and
Awareness Guidance”67 provides recommendations on how to make these ads
perceptually distinctive from product advertising. Both FDA and FTC officials are
watchful when marketers of the only product in a therapeutic category have a
commercial interest in funding a disease awareness ad.68
FDA’s Enforcement Activities
While the law and regulations do not give FDA prior approval authority for
prescription drug advertising, the law does give FDA authority to review the accuracy
of claims in a prescription drug’s promotion. In 2003, FDA received approximately
38,000 ads (known as submissions to the agency) from drug sponsors.69 These
submissions include all types of promotional materials, both broadcast and print
advertisements, and promotional labeling for new products, directed at all audiences
including consumers and health care professionals. In 2003, the agency reviewed
161 broadcast and 221 print DTC ads that had been voluntarily submitted by the
manufacturers to the agency for review prior to release to the public. These voluntary
submissions give FDA an opportunity to object to ads that either omit or minimize
risks, promote unapproved uses of the drug or make unsubstantiated claims about
how effective and safe the drugs are or how effective the advertised drugs are relative
to competitive products.70 In addition, the agency has found that some ads obscure
the warning information that is required.
If the FDA feels that an advertisement for a drug that is before the public does
not contain the required information or is false or misleading, it can respond through
a variety of enforcement actions.71 In most cases, the agency asks the company to
withdraw voluntarily the violative ad. It can send a letter to the company (called an
“untitled letter” by the agency) warning that the advertisement violates the FFDCA.
Often, the letter states that the ad is “misleading” because it overstates or guarantees
the product’s effectiveness, expands the population approved for treatment, or
minimizes the risks of the product. The letter asks that the ad be stopped
immediately. Another letter that FDA can send is a “Warning Letter” directed at
more serious violations.
67 Food and Drug Administration, “Draft Guidance for Industry: ‘Help-Seeking’ and Other
Disease Awareness Communications by or on Behalf of Drug and Device Firms,” Jan. 2004,
available at [http://www.fda.gov/cder/guidance/6019dft.doc].
68 “Disease Awareness Ad Guidance Stresses Need for ‘Distinct’ Messages,” The Pink
Sheet, [F-D-C Reports, Inc., Chevy Chase, MD], Feb. 9, 2004, p. 6.
69 The total submission number was split between 32,000 pieces of promotional materials
directed to health care professionals (such as pens, pins, and labeling) and 6,000 pieces of
promotional material directed at consumers such as booklets, brochures and videos (author’s
conversation with FDA officials).
70 Thomas W. Abrams, Division of Drug Marketing, Advertising, and Communications,
Food and Drug Administration, “DDMAC Update-Regulation of Prescription Drug
Promotion,” Feb. 26, 2004. Slide presentation found at [http://www.fda.gov/cder/ddmac/
71 Between 1999 and April 2002, FDA reviewed the content of 706 broadcast advertisements
for 76 different pharmaceuticals. Forty-six broadcast ads, about 6.5%, warranted some type
of regulatory notice.
In 2004, the agency sent 23 letters concerning violative promotional labeling,
broadcast ads, or print ads that did not comply with regulations. In one case, on
December 21, 2004, FDA issued an “untitled letter” stating that a “patient safety”
print ad made false or misleading safety claims that minimize the risks associated
with Crestor (See text box).72 The company had placed that ad in several newspapers
defending its brand drug in response to recent congressional testimony from an FDA
safety official who had named Crestor among five marketed drugs that, he said,
present significant safety risks.73
A Recent “Untitled Letter”
On December 21, 2004, FDA sent an “untitled letter” to AstraZeneca stating that the
firm’s ads run in large national papers on November 23 and 24, 2004 made “false and
misleading safety claims that minimize the risks associated with Crestor.” FDA claimed
that the ad suggests that Crestor is safer than was demonstrated by substantial evidence
and clinical experience. The letter stated that the company had agreed to a risk
management plan whereby patients in three clinical trials taking a 40 mg dose of Crestor
would be given regular renal monitoring. The 40 mg dose was also to be given only to
patients with severe hypercholesterolemia who did not respond to other treatments.
According to FDA’s letter, the ad headlined the sentence, “You can be assured that at
AstraZeneca, patient safety is our number one priority.” The untitled letter also said that
it appeared to the agency that the Company was seeking to assure readers that Crestor is
“more effective and just as safe as the leading medications in its class.” [emphasis
added] The untitled letter stated that FDA is not aware of evidence or experience
demonstrating that all doses of Crestor are “just as safe” as other statins. Similarly, FDA
expressed concern about the section of the ad that stated: “The FDA has confidence in
the safety and efficacy of CRESTOR. ... The scientists at the FDA who are responsible for
the approval and ongoing review of CRESTOR have, as recently as last Friday, publicly
confirmed that CRESTOR is safe and effective; and that the concerns that have been
raised have no medical or scientific basis.” FDA states that the ad misleadingly suggests
that the Agency does not believe that Crestor poses safety concerns. For this claim, the
AstraZeneca ad cites “www.fda.gov accessed on 11/19/04.” In its letter, FDA notes that
there is no statement on the website by FDA concluding that the concerns about Crestor
have no medical or scientific basis. The letter further states that recent reported
statements made by the Agency contradict that conclusion, referring to an article entitled
“Campaign Waged Against Crestor” appearing the previous week (on November 18,
2004) in the Washington Post. In describing the safety concerns raised by the consumer
advocacy group Public Citizen about Crestor, the article quotes Dr. Steven Galson,
Acting Director of the FDA’s Center for Drug Evaluation and Research, as saying: “[the
Agency] has been very concerned about Crestor since the day it was approved, and we’ve
been watching it very carefully” and that the Agency is “concerned about the same issues
with Crestor as Public Citizen.” FDA’s December 21, 2004 untitled letter therefore
requested AstraZeneca to immediately cease the dissemination of violative promotional
materials for Crestor. The FDA sent another untitled letter to AstraZeneca on March 8,
2005 concerning another Crestor ad. In both letters, FDA requested that the company’s
reply, due in 10 business days, include its plan for discontinuing use of such materials.
Source: See [http://www.fda.gov/cder/warn/warn2004.htm] and [http://www.fda.gov/
72 21 U.S.C. § 352n; 21 C.F.R. §202.1(e)(6)(i).
73 U.S. Congress, Senate Committee on Finance, FDA, Merck and Vioxx: Putting Patient
Safety First?, hearing, 108th Cong., 2nd sess., Nov. 18, 2004, available at
Of the 23, 12 were actual Warning Letters for violative broadcast ads concerning
print materials that did not comply with the regulations.74 Warning Letters state that,
in addition to stopping the violative activity, the company must take corrective steps
by disseminating corrective information to the audience of the violative promotional
materials such as physicians, pharmacists, and patients. At times, companies must
run ads in the same media to correct the misleading impressions. Usually, the
companies respond immediately to the Letter.
If Warning Letters fail to rectify the situation, FDA can work with the
Department of Justice to seek injunctions against companies, or criminally prosecute
firms, or FDA can seize products deemed to be misbranded by intentional and/or
serious misstatements, or can withdraw the drug’s approval. For example, in 1995,
a prominent company pleaded guilty to having promoted its acne treatment drug for
use in treating sun-wrinkled or “photoaged” skin. The company paid a $5 million
fine and $2.5 million for the costs of the investigation. In fact, however, very few
cases have been brought to court for resolution.
The agency has had its authority to regulate DTC advertisements and other
forms of prescription drug promotion examined in the courts. The rulings
emphasized that the agency should not impose unnecessary restrictions on
“commercial speech.”75 In reaction to these decisions, on May 16, 2002, FDA
published in the Federal Register a notice requesting comment by July 30, 2002, on
“commercial speech” issues under the First Amendment.76 In the notice, FDA
mentions an unfavorable court decision on its regulation of commercial speech.77
The finding led the agency to question whether it continues to have legal credibility
to sustain its authority to carry out its public health duties, and, in addition, whether
its position on promotional speech about prescription drugs is valid.78 The notice
solicited public comments about FDA’s legal basis for its regulations, guidances,
74 See [http://www.fda.gov/cder/warn/warn2004.htm].
75 George W. Evans and Arnold I. Friede, “The Food and Drug Administration’s Regulation
of Prescription Drug Manufacturer Speech: A First Amendment Analysis,” Food and Drug
Law Journal, vol. 58, no. 3 (2003), pp. 365-437.
76 U.S. Department of Health and Human Services, Food and Drug Administration, Request
for Comment on First Amendment Issues. 67 Federal Register 34942 (May 16, 2002). See
CRS Report 95-815, Freedom of Speech and Press: Exceptions to the First Amendment, by
77 Thompson v. Western States Medical Center, 535 U.S. 357 (April 29, 2002). In this case,
the Supreme Court struck down a pharmacy-compounding provision in the FDA
Modernization Act (FDAMA). Pharmacy compounding involves a pharmacist mixing a
slightly altered version of a drug for an individual, such as removing a preservative for a
patient who is allergic to that preservative. The FDAMA provision said that a drug could
be compounded only if the physician or pharmacist does not advertise or promote the
compounding of a particular drug, class, or type of drug. The Supreme Court ruled that the
provision’s advertising restrictions violate the First Amendment to the Constitution. FDA
Week, June 21, 2002.
78 “FDA Seeks Comment on Ad Regs: Can Rx Be More Regulated Than OTCs?” The Pink
Sheet, vol. 64, no. 20 (May 20, 2002), p. 14.
policies, and practices to ensure the agency continues to comply with the law. It
Is FDA’s current position regarding direct-to-consumer and other advertisements
consistent with empirical research on the effects of those advertisements, as well
as with relevant legal authority? What are the positive and negative effects, if
any, of industry’s promotion of prescription drugs ...? Does the current
regulatory approach and its implementation by industry lead to over-prescription
of drugs? Do they increase physician visits or patient compliance with
medication regimes? Do they cause patient visits that lead to treatment for
under-diagnosed diseases? Does FDA’s current approach and its implementation
by industry lead to adequate treatment for under-diagnosed diseases? Do they
lead to adequate patient understanding of the potential risks associated with use
of drugs? Does FDA’s current approach and its implementation by industry
create any impediments to the ability of doctors to give optimal medical advice79
or prescribe optimal treatment?
FDA extended the deadline for comments but has not published any formal response.
In another section of the notice, FDA asked whether it should distinguish between
labels and advertisements in the regulation of commercial speech and whether both
should be subject to the same degree of regulation as they are currently.
The General Accounting Office (GAO — now called the Government
Accountability Office) found in 2002 that FDA’s oversight of DTC advertising is
generally effective at halting the dissemination of ads that it reviews and identifies
as misleading. However, GAO also stated that FDA’s oversight has limitations in
two areas. The agency cannot verify that it receives all newly disseminated ads from
drug companies, nor does the agency have the ability to quickly issue regulatory
letters after an violation is identified. FDA/DDMAC used to issue letters a few days
after determining an ad was violative but because of a policy switch all letters must
now go through FDA’s Office of the Chief Counsel where the letters are reviewed
for legal sufficiency and consistency with agency policy. This review can take
between 13 and 78 days according to GAO.80 According to FDA officials, DDMAC
and the Office of Chief Counsel have now streamlined this process to five days for
warning letters and 15 days for untitled letters.81
In addition, in his last speech as the outgoing Chief Counsel of FDA, Daniel
Troy, in November 2004, claimed that the courts had reaffirmed the authority of FDA
to regulate commercial free speech under the First Amendment with regard to DTC
advertising. In the fall of 2004, he established an inter-center coordinating group to
develop guidance documents that will bring transparency to FDA’s regulation of
79 Food and Drug Administration, “Request for Comment on First Amendment Issues,” 67
Federal Register 34943(May 16, 2002).
80 U.S. General Accounting Office, Prescription Drugs: FDA Oversight of Direct-to-
Consumer Advertising Has Limitations, GAO-03-177, Oct. 2002.
81 “FDA Chief Counsel Warning Letter Review to Continue After Troy’s Departure,” The
Pink Sheet, Nov. 22, 2004, p. 14.
promotional communication, and establish common standards for regulating
commercial communications across all FDA’s product areas.82
Two offices within FDA handle the bulk of review and enforcement activities
regarding drug promotion: the Division of Drug Marketing, Advertising, and
Communications (DDMAC), and the Office of Drug Safety (ODS), both units within
the Center for Drug Evaluation and Research (CDER). Table 5 gives the total
resources for DDMAC and for the review of DTC advertisements. It also shows that
the resources used for review of DTC advertisements decreased not only as a
percentage of the total division resources, but also in actual dollars between FY2003,
Table 5. Appropriations for CDER’s Division of Drug Marketing,
Advertising, and Communications FY2003, FY2004 (actual),
FY2005 (projected), and FY2006 (requested)
FY2003 FY2004 FY2005 FY2006
(actua l) (actua l) (projected) (request ed)
Total appropriation for
Division of Drug
Marketing, Advertising, and
Appropriation for the
review of DTC
advertisements $1,069,605 $755,880 $806,525 $883,525
Percentage of DTC review
appropriations as a
percentage of DDMAC total
appropriatio n 25.7% 20.9% 20.8% 20.8%
Source: FDA, Office of Budget and Program Analysis, Budget Formulation and Presentation
Divi sio n.
Another source of funds for regulating DTC advertising could be fees collected
under the Prescription Drug User Fee Act (PDUFA).83 When the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002 (P.L. 107-188)
was enacted, it reauthorized PDUFA (known as PDUFA III) and authorized added
funds for the DDMAC: an increase of $2.5 million for FY2003, $4 million for
FY2004, $5.5 million for FY2005, $7.5 million for FY2006, and $7.5 million for
83 The initial authorization in 1992 restricted FDA’s use of PDUFA user fees to new drug
reviews. PDUFA III, enacted as part of the Public Health Security and Bioterrorism
Preparedness and Response Act [P.L. 107-188], expanded that authority to drug safety
FY2007. The funds were to be used to hire additional staff to monitor broadcast and
Internet ads more vigilantly to ensure that the messages conveyed do not mislead
consumers. The authorization reflected Congress’ general concern over drug safety.84
However, these sums were not appropriated in FY2003, FY2004 or FY2005, nor
were they requested for FY2006.
In the reauthorization process for PDUFA III, FDA committed to doubling (to
almost 100) the number of staff assigned to monitor the side effects of drugs already
on the market. Some of these new hires in FDA’s Office of Drug Safety (ODS) will
be used to increase agency efforts to provide consumers with the latest information
about newly approved drugs.85 Table 6 gives the appropriations for ODS since
FY1999. As is clear from the numbers, the infusion of PDUFA funding has allowed
more reviewers to consider post-market issues.
Table 6. Funding for the CDER’s Office of Drug Safety
and Full-Time Equivalent (FTE) Positions
(millions of dollars)
Fiscal yearsBudget authorityPDUFA (user fees)Total FTEs
FY1999 $10.8 N/Aa $10.8 6 0
FY2000 $17.2 N/A $17.2 6 9
FY2001 $13.5 N/A $13.5 7 6
FY2002 $15.4 N/A $15.4 7 7
FY2003 $13.4 $6.8 $20.2 9 0
FY2004 $15.8 $8.0 $23.8 9 4
Source: Food and Drug Administration, Office of Budget and Program Analysis, Budget Formulation
and Presentation Division. The additional 25 new requested FTE’s for FY2006 came from comments
of FDA’s Chief Financial Officer Kathleen Heuer as reported in Medicine & Health, vol. 59, no. 8,
Feb. 28, 2005.
a. PDUFA funds were not available until FY2003.
Critics contend that the reliance on PDUFA funding for employees has created
a “cozy relationship” between the agency and drugmakers that has led to less scrutiny
84 See CRS Report RL31263, Public Health Security and Bioterrorism Preparedness and
Response Act (P.L. 107-188): Provisions and Changes to Preexisting Law, by C. Stephen
Redhead, Donna Vogt, and Mary Tiemann.
85 See CRS Report RL31453, The Prescription Drug User Fee Act: Structure and
Reauthorization Issues, by Donna Vogt and Blanchard Randall IV.
of ads and other activities. Agency officials and industry spokesmen say that the user
fee funding has not led to a lessening of agency objectivity.86
All pharmaceuticals carry some risks to humans. Human drugs, by their
definition, are intended to affect the structure or function of the body of man and are
intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease87
in humans. At issue in recent congressional hearings is concern that the known
risks from certain drugs have not been made public nor have risks been
systematically evaluated. Some say that DTC ads have, in their presentation,
minimized the risks as portrayed in the ads. In addition, there are unanswered
questions regarding the relative contribution of DTC advertising of prescription drugs
to health and health care generally. Congress in its oversight role is looking at what
FDA can do under current legislative authority and what more authority FDA may
need to meet new challenges.
Risk and Health Information
One concern before Congress is whether physicians are receiving appropriate
risk information to allow them to convey these risks to patients. Some believe that
not only does the risk information need to be more systematically collected and
released so health decisions can be made carefully, but also that more care needs to
be taken with DTC advertising exposure. Adverse reactions to drugs, and negative
interactions of one drug with another, often surface after the drug is used widely in
patient populations. One critic, commenting on the DTC marketing of the COX-2
class of anti-inflammatory drugs, stated:
These drugs were mass-marketed from the moment they were commercially
available in the new world of direct-to-consumer advertising, with unrealistic
expectations about pain relief, marked gastrointestinal protection, and safety.
Rather than a sufficient waiting period after approval to firmly establish safety
in the large, representative “real world” population, the unbridled promotion
exacerbated the public health problem. This is so poignantly clear for an
indication such as arthritis, which is one of the most common conditions88
Yet, DTC advertising has brought benefits to patients. As noted above, survey
information suggests that the increase in the number of DTC ads influences the way
patients find out about certain health conditions. They are also a source of
information about treatment options, benefits, and risks. It has been argued that DTC
advertisements have educated patients and led them to take more responsibility for
86 “User fees debated as potential source of drug safety problems,” FDAnews Drug Daily
Bulletin, vol. 1, no. 246 (Dec. 29, 2004). See [email@example.com].
87 21 U.S.C. § 321(g)(1)
88 Eric J. Topol [editorial], “Arthritis Medicines and Cardiovascular Events — ‘House of
Coxibs’,” JAMA, vol. 293, no. 3 (2005), 366 ff.
their health care, visiting their physicians more regularly so that certain health
conditions are caught early, preventing more costly treatments later.
Critics, however, question the educational component of DTC advertisements
and have suggested that creating greater access to post-marketing surveillance or
clinical trial data, rather than just the information gained through submitted DTC ads,
could provide patients with a different source of information about the adverse
effects sometimes associated with new products.89 If this information were collected
by non-industry, independent sources, or even by FDA, and made available to the
public through the Internet, and possibly also made accessible through local
pharmacies, it could be used to counter any misinformation or omissions contained
in DTC advertising.
Activity Under Current Authority
One question is whether FDA is doing enough with its current authority to
protect consumers from potentially misleading advertisements. Suggested activities
involve FDA review of ad content; FDA-sponsored consumer education; and FDA
enforcement of DTC advertising guidelines. While none of these may require
legislative action to increase FDA’s authority, their successful implementation could
require additional resources.
Pre- and Post-Publication Review. One area of questioning involves the
timing and the extent of FDA’s review of DTC advertisements for accuracy and
balance. As noted above, the law explicitly prohibits FDA from requiring pre-
publication review and approval of ads. However, some manufacturers voluntarily
choose to submit proposed ads to FDA prior to their release to the public to avoid the90
expense of pulling an already launched ad campaign. All manufacturers, however,
must submit to the agency (with Form 2253) the final ad in whatever form it was
disseminated to the public. The agency believes that there is no problem currently
with this voluntary pre-review and after-the-fact system for regulating DTC
advertising. It claims that most of its reviews are timely, and the current statute does
not give FDA the authority to do more than it is doing.91 Agency officials do say that
close monitoring of visual elements of advertisements is, at times, necessary because
some visuals can mislead consumers about the benefits of a drug despite the
apparently balanced audio presentations about risks. Absent any legislative change,
the FDA currently has the statutory authority to impose requirements on the content
of advertisements to ensure that ads provide accurate and unbiased information.
FDA-Mounted Consumer Education. Rather than leaving dissemination
of information about new medications to DTC advertisers, the agency could sponsor
public education campaigns to explain the risks and benefits of various types of
89 “Panel Backs Interactions Database, CERTs, Adverse-Event Repository,” FDA Week, vol.
90 As noted above (p. 20) in 2003, FDA reviewed 161 broadcast and 221 print DTC ads prior
to release to the public.
91 Telephone conversation with FDA DDMAC official, Mar. 11, 2005.
classes of drugs, the role of promotional materials, and the need for patients to talk
to their physicians. FDA could also ensure that any new information with respect to
a particular drug or class of drugs would be widely disseminated particularly if the
new information involved adverse events or new contraindications. FDA could also
study whether consumers understand the risk and benefit information presented by
ads or whether the information (such as Patient Medication Guides) about the risks
and benefits received by the patient with each new prescription used. Nonetheless,
the agency cannot guarantee how patients will use the added information. The FDA
advisory committees that met in February 2005 to assess the safety of Vioxx and
other COX-2 inhibitors discussed how FDA might act if its enforcement system of
“untitled” and “warning” letters did not inhibit biased industry advertisements. They
considered whether FDA itself might create drug information to counter the “biased”
or “unbalanced” pictures the manufacturers present in DTC ads and to provide
patients with medication guides outlining the risks of particular drugs.92
Recently, FDA announced it would create a website, called DrugWatch. In
conjunction with a new Drug Safety Oversight Board (DSB) to oversee the
management of drug safety issues, FDA intends to improve the information on
possible side effects or other safety risks reaching patients and health providers.93
Increase in FDA-Industry Collaboration. Congress could also look at the
experience of New Zealand which permits advertising for prescription, non-
prescription and complementary medicines, medical services, medical devices, and
health claims on food. All ads making therapeutic claims for these products must be
pre-approved by the Association of New Zealand Advertisers, Therapeutic
Advertising Pre-vetting Service.94 Its success, some say, depends in part on the fact
that it is an industry-based self-regulatory advertising framework or code of conduct.
Also, the ads can be banned if found to be in violation, and the media, which depends
92 Gardiner Harris, “F.D.A. Panel Says Pain Relievers Should Remain on Market,” New York
Times, Feb. 18, 2005.
93 See [http://www.fda.gov/oc/factsheets/drugsafety.html].
94 The only other developed country permitting brand advertising of prescription
medications is New Zealand. New Zealand has a representative body called the Advertising
Standards Authority (ASA) comprised of representatives from advertisers, advertising
agencies, and all the media including TV, newspapers, radio, magazines, cinema, and direct
marketing. It has developed a series of codes that seek to maintain standards of advertising
so that ads are not misleading or deceptive. The code for therapeutic advertising covers all
ads where a therapeutic claim is made irrespective of whether the product is a prescription,
nonprescription, or herbal medicine. The code tries to promote voluntary self-regulation by
advertisers. The ASA also funds the Advertising Standards Complaints Board (ASCB).
This ASCB investigates and adjudicates all complaints it receives. Anyone can lodge a
complaint stating the time, date, and channel or media where the ad was aired. Advertisers
must then show that the advertisement adhered to the code. The advantage of this system
is that complaints are processed quickly, often within six weeks. If an ad is found to breach
a code, the media refuse to accept it or air it. In the 13 years of its existence, the ASCB has
had 100% compliance with its adjudication decisions.
on ads for revenue, ensures that they only accept ads that show they have been pre-
approved by the Service and comply with legislative requirements.95
If Congress encouraged it to do so, FDA could establish an advisory panel under
the Federal Advisory Committee Act which could either itself recommend standards
for prescription drug ads, or encourage the drug industry to develop a new set of
standards for self-regulation.96 Some in the drug industry believe that the formation
of another advisory panel is unnecessary, and that the industry itself is able to
voluntarily adopt its own standards to ensure that ads are reliable, understandable,
Increase FDA’s Enforcement Activity. At present, when FDA identifies
an ad that does not follow FDA regulations, it can send a notice of non-compliance
to the drug company (called an untitled letter by the agency); it almost always gets
a satisfactory corrective response, according to the agency. Some question whether
the agency sends enough notices. A second stronger FDA option response is a
“warning letter.” This type of letter contains a deadline by which the ad sponsor
must reply. If there is an unsatisfactory response or none, FDA can seek an
injunction through the Department of Justice. FDA believes that the threat of a
formal warning letter is a powerful tool in its regulatory arsenal. The drug industry
too, believes this warning letter tool is sufficiently strong to gain compliance from
the manufacturing community. Should any regulatory changes be proposed, First
Amendment and commercial speech protections would most likely need to be
consi d ered. 98
Additional Activity Requiring New Authority
Another question is whether FDA has enough current authority to protect
consumers from potentially misleading advertisements. Should Congress decide
there is a need for greater enforcement of standards for ads, it could strengthen
95 Janet Hoek and Philip Gendall, “Direct-to-Consumer Advertising Down Under: An
Alternative Perspective and Regulatory Framework,” Journal of Public Policy & Marketing,
vol. 21, no. 2 (fall 2003), p. 202. Similar to U.S. law, New Zealand requires that the
advertisement contain active ingredients and quantity, authorized uses, appropriate
precautions, contra-indications, adverse reactions, the line that says “prescription medicine,
and the name and address of the advertiser.”
96 PhRMA adopted on April 18, 2002, a new voluntary marketing code to govern the
pharmaceutical industry’s relationships with physicians and other healthcare professionals.
It says that all interactions should be focused on informing healthcare professionals about
products, providing scientific and educational information, and supporting medical research
and education, available at [http://www.phrma.org/mediaroom/press/releases/
97 Testimony of Executive Director of EthicAd, Michael S. Shaw, in U.S. Congress, Senate
Committee on Commerce, Science, and Transportation, Subcommittee on Consumer Affairs,
Foreign Commerce, and Tourism, Direct-to-Consumer Advertising of Prescription Drugs,thst
hearing, 107 Cong., 1 sess., July 24, 2001.
98 For more information on First Amendment issues, see CRS Report 95-815, Freedom of
Speech and Press: Exceptions to the First Amendment, by Henry Cohen.
FDA’s ability to regulate these ads. It could also authorize more review, set different
standards for ads, or even ban certain ads.
Increase Compliance and Enforcement Tools. Congress could give
FDA the authority to impose punitive sanctions against companies that violate the
law. For example, Congress could authorize civil monetary penalties so FDA could
impose penalties in amounts high enough to encourage greater company compliance.
Require Pre-Release Review. Should Congress decide it was necessary,
it could authorize FDA to review and approve all or a subset of DTC ads prior to
their release to the public. One suggestion discussed in the federal advisory meeting
mentioned above would be to categorize ads depending on the drug it was advertising
so that if the opportunity for harm from misleading information is seen as large then
a more rigorous review could be instituted.
Set Limits on Timing and Placement of Ads. Some suggest that the
agency could also limit the number, type, or content of ads for a particular drug, or
the places where the ad was aired, or when the ads could be seen. Others suggest
aggressive oversight could increase the likelihood of effective self regulation by the99
industry. Ray Woosley, president of the Critical Path Institute at the University of
Arizona stated that a new drug’s benefit-risk ratio should be better understood before
millions of people are put at risk. He suggested that the agency require data
collection on all new drugs that advertise to consumers.100 In addition, drug
companies may want to look at advertising in smaller markets rather than attempting
to create national blockbuster sales. Carl Nathan off the Weill Medical College of
Cornell University in Ithaca, N.Y. suggested that companies might take a few good
drugs and market them conservatively.101
Ban DTC Advertising. Many members of the federal drug advisory panel
that considered the COX-2 inhibitors recommended banning DTC ads for these
drugs; some recommending a ban on all DTC advertising. A former FDA official,
William Schultz, suggested at the Senate Health, Education, Labor and Pension
hearing on March 1, 2005, that “[o]ne possibility is to ban consumer advertising for
a period of time (one or two years) after a drug has been approved, as additional data
are collected on the drug’s safety. Another alternative is to require more explicit and
more prominent disclosures [in the ads] about the safety of prescription drugs. In the
case of new drugs, manufacturers could be required to include a standard disclosure
about the inherent risks of new drugs.”102
99 Frank et al., Prescription Drug Policy Issues, p. 124.
100 “Academic Hopes to Partner with FDA on Tiered Drug-Approval Plan,” Inside Health
Policy, Mar. 3, 2005.
101 Rob Stein, “Studies on Painkillers in Jeopardy: Researchers Assess Risk-Benefit Ratio,”
Washington Post, Dec. 26, 2004, p. A1.
102 Testimony of William B. Schultz, in U.S. Congress, Senate Committee on Health,
Education, Labor and Pensions, FDA’s Drug Approval Process: Up to the Challenge?thst
hearings, 109 Cong., 1 sess., Mar. 1, 2005.
Previously Proposed Legislation
So far, no bills have been introduced into the 109th Congress that would have
a direct impact on DTC advertising. Several congressional Members proposed
legislation in the 108th Congress that would have affected DTC advertising. One bill
would have amended the Internal Revenue Code to prohibit a deduction for any
amount paid or incurred by the manufacturer for a direct-to-consumer advertisement
of a prescription drug.103 Another would have denied tax deductions for DTC
advertising if drug makers failed to provide information about risks or presented the
drugs in an unbalanced way, or if the agency determined that a drug’s risks were not
listed in the advertisement in the same proportion as its benefits.104 A third would
have mandated comparative research on the effectiveness and safety of drugs covered
by the Federal Employees Health Benefits Program.105 It also would have required
regulations for ads, mandating that the advertisements balance risk and benefit
information, set civil penalties for violations, and required an annual report which
specified details of all DTC ads, including which ads violated the law and describing
what the Secretary of Health and Human Services had done to respond to the
violation. It also would have required expedited review of DTC ads. None of these
bills was reported out of their committees of referral.
DTC promotes the advantages of prescription drugs and is used to sell drugs by
manufacturers. The issue for Congress is whether FDA’s current policies on DTC
ads give consumers information that is balanced with risks and benefits represented
equally, and whether ads misrepresent important information patients need prior to
purchasing or consuming the drug. The agency and others say that evidence suggests
that DTC ads influence the way patients find out about certain health conditions.
Supporters point to the ads as a source of information about treatment options,
benefits, and risks. They also attributed to ads educating patients and leading them
to take more responsibility for their health care, visiting their physicians more
regularly so that certain health conditions are caught early, and preventing more
costly treatments later.
Others argue for stricter requirements for ads coupled with penalties for
infractions to assure consumers of a balance in the information about drugs. They
suggest that ads should be approved prior to release to the public to ensure the risk
and benefit of the drugs are balanced. Still others have suggested banning or severely
limiting ads until a drug’s safety profile becomes more extensive.
103 The Say No to Drug Ads Act (H.R. 149), Rep. Jerrold Nadler.
104 The Fair Balance Prescription Drug Advertisement Act of 2003 (H.R. 3155), Rep. Pete
105 The Direct to Consumer Prescription Drug Advertising Act of 2004 (S. 2445), Sen. John
Edwards. The text of S. 2445 was presented and defeated twice as amendments to the
Prescription Drug and Medicare Improvement Act of 2003.
With the level of congressional and public interest in drug safety and consumer
and physician access to information, FDA and Congress may consider whether and
if so how to regulate DTC advertising to bolster its potential positive impact on
consumer and physician knowledge and choice while protecting against the potential
of the ads to accentuate the benefits and downplay the risks of prescription drugs