Emergency Contraception: Plan B

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On August 24, 2006, the Food and Drug Administration (FDA) announced the approval of an
application to switch Plan B, an emergency contraceptive, from a prescription-only drug to an
over-the-counter (OTC) drug for women 18 years of age and older. Plan B will only be sold in
pharmacies or healthcare clinics. It will continue to be dispensed as a prescription drug for
women 17 years old and younger. Plan B is a brand of post-coital contraceptive that is
administered within a few hours or days of unprotected intercourse. Emergency contraception
prevents pregnancy; it does not disrupt an established pregnancy.
Approval of the switch to OTC status for Plan B has been controversial. Some Members of
Congress urged the FDA to deny OTC status for Plan B. Individuals who criticize the three-year
delay in deciding to switch to OTC believe that Bush Administration policy and FDA actions
were based on political and ideological considerations rather than on sound science. Conservative
religious and pro-life groups believe Plan B may increase unsafe sexual activity and should be
used only under the supervision of a healthcare professional and, therefore, should not be
available OTC. Their major concern with Plan B, however, is that it might prevent the
implantation of an embryo in the uterus, which to pro-life groups constitutes abortion. However,
the medical community does not consider prevention of implantation to be an abortion, and FDA
does not classify Plan B as an abortion drug.
Emergency contraceptives are currently available without a prescription in more than 40
countries. According to Barr Pharmaceuticals, sales of Plan B in the United States have doubled
since August 2006, “rising from about $40 million a year to what will probably be close to $80
million for 2007.” Women’s health advocates claim that OTC status will improve access to the
drug, thereby reducing the number of unintended pregnancies and reducing the number of
abortions. However, a medical literature review, published in April 2007, found that “advance
provision of emergency contraception did not reduce pregnancy rates when compared to
conventional provision.... The interventions tested thus far have not reduced overall pregnancy
rates in the populations studied.”
The Office of Violence Against Women within the Department of Justice (DOJ) has developed
guidelines for the treatment of sexual assault victims. The guidelines, released in September
2004, have been criticized by numerous organizations because they do not mention offering
emergency contraception to female rape victims. In January 2005, a letter signed by 97 Members
of Congress was sent to the Director of the Office on Violence Against Women expressing
concern over the failure to mention emergency contraception and urging that the guidelines be
changed to include such information.
Legislation introduced in the 110^th Congress (S. 21/H.R. 819, H.R. 464, S. 1240, H.R. 2064/S.
1800, H.R. 2503, H.R. 2596/S. 1555) aims to ensure that Plan B is made available to women in
general and sexual assault victims in particular or encourage education and provide information
about Plan B. This report will be updated as events warrant.

Introduc tion ..................................................................................................................................... 1
Background Information on Emergency Contraception..................................................................2
FDA Approval of Preven and Plan B..............................................................................................3
Mechanism of Action................................................................................................................4
Contraindications and Adverse Reactions.................................................................................5
FDA Approval of Over-the-Counter Status for Plan B....................................................................6
Legal Issues.....................................................................................................................................8
State Policies.................................................................................................................................12
Justice Department Guidelines for Sexual Assault Victims..........................................................14
Federal Legislation........................................................................................................................16
Impact of the FDA OTC Decision.................................................................................................17
Table 1. Nonprescription Availability of Plan B..............................................................................2
Author Contact Information..........................................................................................................20

On August 24, 2006, the Food and Drug Administration (FDA) announced the approval of an
application to switch Plan B, an emergency contraceptive, from a prescription-only drug to an
over-the-counter (OTC) drug for women 18 years of age and older. Plan B will only be sold OTC
in pharmacies or healthcare clinics. It will continue to be dispensed as a prescription drug for
women 17 years old and younger. Both men and women will be able to purchase Plan B, but all
individuals will need to show the pharmacist identification for proof of age before purchasing the ¹
OTC version. Anonymous shoppers will be used to test compliance with the age restriction. A
booklet will be distributed with Plan B that explains proper use of the drug. The manufacturer,
Barr Pharmaceuticals, began shipping the OTC version of the drug to U.S. pharmacies early in ²
November 2006.
Approval of the switch to OTC for Plan B has been controversial. Critics believe that initial
policy decisions made by the Bush Administration regarding Plan B were based on political and ³
ideological considerations rather than on sound science. Conservative religious and pro-life
groups believe that readily available Plan B may increase the occurrence of unsafe sexual activity
and that such a drug should be used only under the supervision of a healthcare professional. Their
primary concern with Plan B, however, is that it might prevent the implantation of the embryo in
the uterus, which, for those who believe human life begins at conception, would constitute an
abortion. However, the medical community does not consider prevention of implantation to be an
abortion, and FDA does not classify Plan B as an abortion drug. Although the precise mechanism
of action remains undetermined, scientific evidence suggests that prevention of ovulation or
fertilization is the most likely mode of action for Plan B, rather than prevention of implantation of ⁴
a developing embryo.
This report discusses the FDA approval of Plan B as a prescription drug, as well as the more
recent and controversial FDA approval of Plan B as an OTC drug. Legal issues regarding the
recent FDA decision are also discussed as well as various state policies that affect access to
emergency contraceptives. In addition, the report discusses the Department of Justice guidelines
for the treatment of sexual assault victims, which have been criticized by numerous organizations
because they do not mention offering emergency contraception to female rape victims. The DOJ ^th
guidelines were the focus of legislation introduced in the 109 Congress. Lastly, this report
discusses the likely impact of the FDA Plan B OTC decision.

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¹⁰⁹^8.

Emergency contraception is a therapy that may prevent pregnancy for women who have had
unprotected sexual intercourse. There are two methods of emergency contraceptive therapy:
insertion of an intrauterine devise, or IUD, within five days of intercourse; or, ingestion of a pill
containing the hormones commonly found in the contraceptive pill. Although hormonal
emergency contraception is often referred to as the “morning-after pill,” it can be given up to 72
hours after unprotected intercourse and can involve taking more than one pill. Reasons for using
emergency contraception include problems with a contraceptive (condom breakage, missed pill),
sexual assault, or exposure to an agent which may cause a birth defect (e.g., live vaccine,
cytotoxic drug, or radiation).
The current approach to emergency conception began with the recognition in the 1920s that
estrogen prevented pregnancy in mammals. In the mid-1960s, a Dutch physician gave high-dose
estrogen to a 13-year-old rape victim in order to prevent pregnancy. During the 1960s and 1970s
high-dose estrogen became the standard emergency contraceptive treatment. In the early 1970s,
Canadian physician A. Albert Yuzpe began studying emergency contraception and published his
first study in 1974. The Yuzpe method used conventional birth control pills, a combination of ⁵
estrogen and progestin, taken in two doses 12 hours apart. In 1984, the United Kingdom became
the first country to approve such a combination pill regimen as an emergency contraceptive.
In January 2001, the United Kingdom began allowing pharmacies to dispense emergency ⁶
contraception without a prescription. In April 2005, an emergency contraceptive (Plan B, a
progestin-only pill) was approved by the Canadian government for use by all women without a ⁷
prescription. Emergency contraceptive pills are used by women in more than 100 countries; in
over 40 countries the pills are sold without prescription either by a pharmacist or OTC (see Table ⁸

1, below).

Table 1. Nonprescription Availability of Plan B
^{Over-the-counter}
^{India, Netherlands, Norway, Swe}^den
^{Directly from a Pha}^rma^cist
^{Aruba, Au}^{stralia, Belgium, Benin,}^{Burkina Faso, Cameroon, Canada, China, Congo, Denmark, Estonia, Finland, France,}
^{French Polynesia, Gabo}^{n, Gha}^{na, Greece, G}^{uinea-Conakry, Iceland}^{, Israel, Jamaica, Latvia, Libya, Lux}^{embourg, Mali,}
^{Mauritania, Mau}^{ritius, New Zealand, Niger, Portugal, Senegal, S}^lov^{akia, South Africa, Sri Lanka, Swit}^{zerland, Togo}^,
^{Tunisia, United Kingdom}

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Following the 1974 publication by Yuzpe, physicians often instructed patients to take multiple
pills from a standard one-cycle oral contraceptive package for emergency contraception; this is ⁹
referred to as an “off-label” use of the drug. On February 25, 1997, a notice in the Federal
Register stated that the Commissioner of FDA had concluded that certain oral contraceptives are
safe and effective for use as emergency contraception and asked manufacturers to submit a new
drug application for this use. In 1998, FDA approved Preven for use as an emergency
contraceptive available by prescription. Preven utilized the Yuzpe method; two pills, containing
estrogen and progestin, taken 12 hours apart.
A 1993 study conducted on about 800 women in Hong Kong found that use of progestin alone
was somewhat more effective for emergency contraception than the Yuzpe method and had fewer ¹⁰
side effects. In 1998, the World Health Organization (WHO) followed up with a larger
international trial using almost 2,000 women comparing the Yuzpe method and a progestin-only ¹¹
pill. The WHO trial found that progestin alone was significantly more effective than the Yuzpe
method at preventing pregnancy, and caused fewer side effects. Most importantly, for either
method, the WHO trial found that the earlier the pill is taken, the better it works.
In the WHO trial, the progestin-alone regimen reduced the risk of pregnancy by 85% when taken
within 72 hours of intercourse. Progestin prevented 95% of expected pregnancies when taken
within 24 hours, 85% when taken between 25 and 48 hours, and 58% when taken between 49 and

72 hours. In contrast, Yuzpe reduced the risk of pregnancy by 57% when taken within 72 hours.

Yuzpe prevented 77% of expected pregnancies when taken within 24 hours, 36% for 25 to 48
hours, and 31% for 49 to 72 hours. WHO also found that the Yuzpe method resulted in
significantly more side effects than progestin alone. The incidence of nausea was 50% with Yuzpe
and 23% with progestin. Vomiting with Yuzpe was 3 times higher than with progestin (19% vs.

6%), which is significant as women who vomit after taking the first combination pill may need to ¹²

take an extra dose.
On July 28, 1999, FDA approved Plan B, a progestin-only emergency contraceptive, for use by
prescription. Plan B consists of two pills each containing 0.75 mg of levonorgestrel (a ¹³
progestin). One pill is taken as soon as possible after unprotected intercourse and the second is

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¹⁹⁹^{8, pp}^.⁴^28-⁴³^3.
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taken 12 hours later.¹⁴ The FDA-approved labeling for Plan B states that it is 89% effective if
taken within three days (72 hours) after unprotected sex. In other words, 7 of every 8 women who
would have become pregnant will not become pregnant. As mentioned earlier, Plan B is even
more effective (95%) if taken within 24 hours of unprotected sex.
In humans, the fertile days when sexual intercourse can result in pregnancy include the five days
before ovulation (release of the egg from the ovary) and the day of ovulation. Although the
precise mechanism of action by which Plan B prevents pregnancy remains undetermined,
scientific evidence suggests that prevention of ovulation or fertilization is the most likely mode of ¹⁵
action for Plan B, rather than prevention of implantation. The active ingredient in Plan B,
levonorgestrel, has been used in birth control pills for more than 35 years. Emergency
contraception is not as effective as the regular use of oral contraceptives. However, the higher
dose of levonorgestrel in Plan B works like a birth control pill to prevent pregnancy, most
probably by stopping ovulation. Several studies indicate that hormonal emergency contraception ¹⁶
interferes with the events in the ovary that lead up to release of the egg.
Plan B may also interfere with fertilization by altering the transport of sperm and/or egg within
the female reproductive system. In one study, administration of levonorgestrel after sexual
intercourse reduced the number of sperm within the uterus, increased the pH of the uterine fluid
(which immobilized sperm), and increased the viscosity of cervical mucus (which impeded entry ¹⁷
of sperm into the uterus).
It is possible that Plan B may inhibit implantation of the fertilized egg within the uterus by
altering the endometrium (the uterine lining). Three studies of hormonal emergency contraception
in human subjects found alterations in the endometrium, but whether such changes had an impact ¹⁸
on implantation was “open to question.” Four other studies found either negligible or no
alterations in the endometrium. However, in the case of levonorgestrel, “publications in refereed
journals do not support the hypothesis that it alters endometrial receptivity or impedes ¹⁹
implantation.” In addition, studies in the rat and monkey indicate that levonorgestrel does not ²⁰
disrupt post-fertilization events such as implantation.

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^jus^t^a^s^e^f^f^e^c^tive^.^H^e^le^na^v^{on H}^e^r^t^z^eⁿ^e^t^a^l^{., “}^L^ow^D^o^s^e^Mif^e^pr^is^tone^a^{nd T}^w^{o R}^e^gⁱ^m^e^ns^of^L^e^v^onor^g^e^s^t^r^e^l^f^o^r
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¹⁵^Ho^raci^o^B.^Cr^o^x^at^t^o^et^al^.^,^“M^ech^anⁱ^s^m^s^o^f^A^c^tⁱ^oⁿ^o^f^E^m^er^gen^c^y^Coⁿ^t^racep^tⁱ^oⁿ^,^”^Ste^r^oi^ds^{, v}^.⁶⁸^,²⁰⁰³^{, p}^p^.¹⁰^95-
¹⁰⁹^8.
¹⁶^Ibid^.
¹⁷^E^.^Kesseru^et^al^.^,^“T^h^e^Ho^rm^oⁿ^a^l^an^d^P^e^ri^p^h^e^ral^E^f^f^ect^{s o}^f^d^l^-No^r^g^e^st^relⁱⁿ^P^o^st^coⁱ^t^a^l^C^oⁿ^t^racep^tⁱ^oⁿ^,^”
^C^ontr^a^c^e^p^tioⁿ^{, v}^.^10,¹⁹⁷⁴^,^pp.⁴^11-⁴²^4.
¹⁸^Ho^raci^o^B.^Cr^o^x^at^t^o^et^al^.^,^“M^ech^anⁱ^s^m^s^o^f^A^c^tⁱ^oⁿ^o^f^E^m^er^gen^c^y^Coⁿ^t^racep^tⁱ^oⁿ^,^”^Ste^r^oi^ds^{, v}^.⁶⁸^,²⁰⁰³^{, p}^p^.¹⁰^95-
¹⁰⁹^8.
¹⁹^Ibid^.
²⁰^Ibid^.

Plan B is not effective after the embryo has implanted in the uterus and therefore cannot interfere
with an established pregnancy, which is defined as an embryo implanted in a uterus. Plan B is
used before a pregnancy can be diagnosed. Plan B does not use the same active ingredient as
Mifeprex (also known as the abortion pill, RU-486, or mifepristone). Mifeprex (in combination
with misoprostol) is used after a positive pregnancy test to terminate an early pregnancy (up ²¹
through seven weeks).
The fact that there are relatively few side effects for Plan B was a major factor in the approval of
OTC status for this drug. The FDA-approved OTC labeling lists known pregnancy and
hypersensitivity to any component of the product as contraindications. For Preven or the Yuzpe
regimen, the FDA, WHO, and the American College of Obstetricians and Gynecologists (ACOG)
list known pregnancy as the only contraindication. (Pregnancy is listed as a contraindication only
because these drugs won’t work to prevent pregnancy if the patient is already pregnant; no harm
will result if a pregnant patient takes either pill.) The FDA, however, lists some relative
contraindications based on evidence from combination estrogen-progestin oral contraceptives.
These include clotting problems, stroke, and migraine, among others, which are related to the
presence of estrogen in the combination pill. A 1997 review found that since the Yuzpe regimen
was approved in 1984 in the UK, the product was used more than 4 million times; only six
serious stroke or blood clot events were reported, and there was no clear-cut relationship between ²²
drug administration and any of these events. In contrast, such events are much more likely
during pregnancy (60 cases/100,000 women). Without the presence of estrogen, the incidence of
such events for use of Plan B should be even lower than the Yuzpe regimen.
Adverse reactions to Plan B listed in the FDA-approved label include nausea (23%), abdominal
pain (18%), fatigue (17%), and headache (17%). Less common adverse events listed on the label
include menstrual changes, dizziness, breast tenderness, vomiting, and diarrhea. There is no ²³
medical evidence that Plan B will harm a developing fetus if taken accidentally while pregnant.
Several studies have shown that availability of Plan B does not lead to an increase in unprotected ²⁴
sex.

²¹^C^R^S^R^e^por^{t R}^L³⁰⁸⁶⁶^,^A^bor^ti^on:^Te^r^m^inati^oⁿ^of^Ear^l^y^Pr^e^g^na^nc^y^w^{ith RU}^-⁴⁸⁶⁽^M^ife^pr^is^tone⁾^,^by^Judit^h^A^.
^J^ohns^on.
²²^Aⁿⁿ^a^G^l^asi^e^r,^“E^m^e^rg^en^c^y^P^o^st^c^oⁱ^t^a^l^Con^t^racep^tⁱ^oⁿ^,^”^The^N^e^w^Eⁿ^gla^{nd J}^ourⁿ^a^l^{of M}^e^dicⁱ^ne^{, v.}³³^7,^Oct^o^b^e^r⁹^,
¹⁹⁹^{7, pp}^.¹⁰⁵⁸^-¹⁰⁶^4.
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^A^d^vi^so^r^y^Co^mmⁱ^t^t^{ee M}^eetⁱⁿ^{g o}ⁿ^P^l^aⁿ^B,^Decem^b^e^{r 1}⁶^,²⁰⁰³^h^t^t^p^:^/^/^www^.^f^d^a^.^g^o^v^/^o^h^r^m^s^/^d^o^c^ket^s^/^ac/⁰³^/^t^r^an^scri^p^t^s/
⁴⁰¹^5T^1.h^t^m^.
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^Coⁿ^t^racep^tⁱ^oⁿ^T^h^r^o^u^g^h^P^h^arm^aci^{es an}^d^E^f^f^e^ct^oⁿ^Uniⁿ^t^e^nd^ed^P^r^egn^aⁿ^c^y^an^d^S^T^Is,^”^Jo^u^rⁿ^a^l^o^f^t^h^{e Ameri}^can^M^e^dⁱ^cal
^A^s^s^o^cⁱ^a^{tion, v}^.²⁹^{3, J}^aⁿ^u^a^r^y^{5, 20}^05,^pp^{. 5}⁴^-⁶^{2; a}^nd,^C^y^nthia^H^a^r^p^e^r^e^t^a^l^{., “}^T^he^Ef^f^e^c^t^of^Iⁿ^c^r^e^a^s^e^{d A}^c^c^e^s^s^to
^E^m^er^gen^c^y^Coⁿ^t^racep^tⁱ^oⁿ^A^m^oⁿ^g^Y^oung^A^dole^s^c^eⁿ^ts^,”^O^b^s^t^e^t^rⁱ^c^s^a^{nd G}^y^nec^o^log^y^{, v}^.^{106, Se}^pte^m^be^r²⁰⁰⁵^{, p}^p^.⁴⁸^3-
⁴⁹¹^.

In April 2003, Women’s Capital Corporation (WCC) submitted an application to the FDA ²⁵
requesting that Plan B be switched from prescription to OTC. Requiring a prescription for
emergency contraception may create barriers to access for many women. The woman must: (1)
identify a physician who will prescribe Plan B; (2) obtain a prescription via a telephone call or a
physician visit and pay the financial cost of the visit; and, (3) find a pharmacy that stocks the
product and employs a pharmacist who will dispense the product. Because the effective use of
Plan B is time dependent (the earlier it is used, the more effective it is), a switch from
“prescription only” to “over-the-counter” (OTC) would likely benefit women who may need to
use this product.
FDA formalized the process of switching a prescription drug to OTC status in 1975 and has
approved over 90 such applications. The requirements for making the switch from prescription-
only to OTC include making sure the drug is safe for self-medication and has a low toxicity or ²⁶
other potentiality for harmful effect. The patient must be able to recognize the condition and
require minimal health care provider intervention in order to use the drug correctly. The OTC
applications are reviewed by FDA’s Center for Drug Evaluation and Research (CDER). Because
it is considered to be a “first in class” drug, the Plan B application was reviewed by two (rather
than one) of the six offices within CDER, one office with expertise in reproductive health and a
second office that reviews all OTC switch applications.
CDER also requested a joint meeting of two advisory committees of outside experts in order to
obtain scientific advice on the Plan B application. The two committees, the Nonprescription
Drugs Advisory Committee and the Advisory Committee for Reproductive Health Drugs, met in ²⁷
December 2003. After reviewing over 15,000 pages of data and 40 scientific studies, the
committees voted unanimously that Plan B is safe for use in the nonprescription setting, and ²⁸
voted 23 to 4 that the Plan B switch to OTC status should be approved.
In May 2004 the FDA rejected the advice of its scientific committee and issued a “not-
approvable” letter for the Plan B switch to OTC. The FDA cited “inadequate sampling” of women

²⁵^W^{CC s}^ubm^itte^{d a}^s^upple^m^eⁿ^ta^{l ne}^w^drug^a^pplic^a^tioⁿ^un^de^{r s}^e^c^tio^{n 5}⁰⁵⁽^b)^of^the^Fe^de^ra^{l F}^o^o^d^{, D}^r^u^g^,^a^{nd Cos}^m^e^tic
^A^c^t^f^o^r^P^l^aⁿ^B^.^Iⁿ^Fe^br^ua^r^y²⁰⁰⁴^,^W^C^C^s^o^{ld t}^h^e^rⁱ^g^h^ts^t^o^m^a^r^k^e^t^P^l^aⁿ^B^to^B^a^r^r^P^h^a^r^m^aceu^tⁱ^cal^s.^Ba^{rr h}^a^d^b^e^guⁿ
^actⁱⁿ^{g as t}^h^{e agen}^t^f^o^{r W}^{CC reg}^a^rdⁱⁿ^g^P^l^aⁿ^{B i}ⁿ^Oct^o^b^e^{r 20}⁰³^.^[^G^A^O^Rep^o^r^t^,^No^ve^m^b^{er 2}⁰⁰⁵^.^]^D^u^ra^m^e^d^Resear^ch^,
^In^{c., t}^h^{e cu}^rren^t^s^p^oⁿ^so^r^o^f^Plan^{B, is a su}^b^sⁱ^d^iary^o^f^Barr.
²⁶^Se^e^{21 C}^.^F.R^.³^10.²⁰⁰⁽^b)⁽²⁰⁰⁵⁾^.
²⁷^A^traⁿ^s^c^{ript of}^the^D^e^c^e^m^b^e^r^16,²⁰^03,^m^e^e^ting^c^aⁿ^be^f^{ound a}^t^ht^tp://w^w^w^.^f^da^.g^ov^/^ohrm^s^/doc^k^e^ts^/a^c^/^03/^traⁿ^s^c^ripts^/
⁴⁰¹^5T^1.h^t^m^.
²⁸^T^h^e^FDA^a^d^vⁱ^sor^y^c^o^m^m^itte^e^m^e^m^b^e^r^{s v}^o^te^{d on}^six^que^sti^{ons; a}^c^tua^l^v^o^te^c^o^unt^{is in}^bra^c^k^e^t^s.^Qu^e^s^tⁱ^on¹^{: Doe}^s^the
^a^c^t^ua^{l us}^e^s^t^udy^de^m^ons^tr^a^t^e^tha^t^c^ons^um^e^r^s^us^e^d^the^pr^od^uc^{t a}^s^r^e^c^o^m^m^e^nde^{d in}^the^pr^o^pos^e^d^la^be^lⁱ^ng^?^[^{27 y}^e^s^,^one
^no^]^Qu^e^s^tⁱ^oⁿ²^{: A}^r^e^the^a^c^t^ua^{l us}^e^s^t^udy^da^ta^g^e^ne^r^a^liz^a^b^le^{to the}^o^v^e^r^a^{ll popu}^la^tio^{n of}^p^o^te^ntia^l^noⁿ^-^R^x^us^e^r^s^of^P^l^aⁿ
^B^?^[²^{7 y}^e^s^,^oneⁿ^o^]^Qu^e^s^tⁱ^on³^:^Ba^se^{d on t}^h^e^a^c^t^ua^{l use}^st^udy^aⁿ^d^lite^ra^ture^re^vⁱ^e^w^{, is the}^r^e^e^v^ideⁿ^c^e^tha^tⁿ^on-Rx
^av^ailab^ility^o^f^P^l^an^{B lead}^{s t}^o^su^b^s^titu^ti^oⁿ^o^f^e^m^erg^eⁿ^c^y^coⁿ^t^racep^tiv^{e f}^o^{r th}^{e reg}^u^{lar u}^s^{e o}^f^o^t^h^e^{r m}^e^th^o^d^{s o}^f
^coⁿ^t^racep^tⁱ^oⁿ^?^[^zero^y^e^s,²⁸^no]^Qu^e^s^tⁱ^on⁴^:^Do^t^h^{e d}^a^t^a^d^e^m^oⁿ^s^t^r^at^{e t}^h^at^P^l^{an B i}^s^saf^e^f^o^{r u}^s^{e i}ⁿ^t^h^{e n}^oⁿ^p^r^escri^p^tⁱ^oⁿ
^se^tting^?^[²^{8 y}^e^{s, z}^e^r^{o no}^]^Qu^e^s^tⁱ^on⁵^{: A}^r^e^the^plaⁿ^{s f}^o^{r intr}^od^uc^tio^{n of}^P^l^aⁿ^B^int^o^t^h^eⁿ^on-Rx^se^ttiⁿ^g^a^d^e^qua^te^w^ith
^resp^ect^t^o^coⁿ^s^u^m^{er acc}^{ess an}^d^saf^e^u^s^{e? [}²²^y^e^s,^fⁱ^{ve n}^o^,^on^{e ab}^st^aⁱ^n]^Qu^e^s^tⁱ^on⁶^{: Sh}^oul^d^Plaⁿ^B^be^s^w^itc^he^{d f}^r^o^m
^pr^e^s^c^r^iptio^{n t}^oⁿ^on-^pr^e^s^c^r^ipti^{on s}^t^a^t^us^?^[^{27 v}^o^t^e^s^{: 23}^y^e^s^,^f^ourⁿ^o^]^.

under 16 years of age as the reason for the rejection and concerns about use of the drug without
supervision by a physician or other health care provider. However, studies published in 2004 and

2005 do not support an association between wider availability of emergency contraception and an ²⁹

increase in unsafe sexual behavior among teenagers. Counseling against unsafe behavior in this
age group is presumably the reason why FDA believed the supervision of a physician was
required.
Barr Labs reapplied in July 2004, requesting that Plan B be available over the counter only to
women 17 years and older. The FDA did not issue a decision by its regulatory deadline of January
2005. At his confirmation hearing in March 2005, FDA Commissioner Lester M. Crawford
indicated that “the science part is generally done” for the Plan B approval process, and “we’re ³⁰
just now down to what the label will look like.”
FDA announced on August 26, 2005, that an immediate decision on the OTC switch could not be
determined. FDA Commissioner Lester Crawford cited “novel regulatory issues,” “profound”
policy questions, and specific concerns over how the exact same formulation of the drug could be
available OTC for an older group of women while remaining prescription only for the younger
group. A 60-day “public comment” period was opened to help decide these issues. This
announcement led to the resignation on August 31 of the director of the FDA’s Office of Women’s
Health, Susan Wood, in protest of the agency’s action. FDA Commissioner Crawford resigned
abruptly on September 23, 2005, reportedly due to financial improprieties unrelated to the
ongoing controversy over Plan B.
When the comment period ended on November 1, 2005, FDA had received approximately 47,000 ³¹
comments. On that same day Senators Hillary Clinton and Patty Murray delivered a 10,000-
name petition urging the agency to “expeditiously make a decision on the application for OTC ³²
status for Plan B based strictly on scientific evidence.”
Members of Congress asked the Government Accountability Office (GAO) to investigate if there
was political interference in the FDA decision process. The GAO report, released in November
2005, stated that the process was “unusual” and that the decision may have been made months
before the scientific reviews were completed. It noted that it was “not typical of the other 67
proposed prescription-to-OTC switch decisions made from 1994 through 2004” for two reasons.
First, it was the only decision that was not approved after the members of the advisory
committees voted to approve the application. Second, the GAO reported that three high-level
FDA officials had declined to sign the letter that refused approval. “This action removed
decision-making authority from the directors of the reviewing offices who would normally make

²⁹^M^e^l^aⁿⁱ^{e A}^.^G^o^l^d^et^al^.^,^“T^h^e^E^f^fect^{s o}^f^A^d^van^{ce P}^r^o^vⁱ^sⁱ^oⁿ^o^f^E^m^ergen^c^y^Coⁿ^t^racep^tⁱ^oⁿ^oⁿ^A^d^o^l^es^cen^t^W^o^men^’^s
^S^e^xu^al^an^d^C^oⁿ^t^racep^tⁱ^v^{e Beh}^a^vi^o^r^s,^”^J^our^nal^of^Pe^dia^t^rⁱ^c^an^{d A}^d^ole^s^c^eⁿ^{t G}^y^ne^c^o^lo^gy^{, v}^.¹⁷^{, A}^p^rⁱ^l²⁰^04,^p^p^.^87-^96;
^an^d^,^Cyⁿ^t^hⁱ^{a Harp}^{er et}^al^.^,^“T^h^e^E^f^f^ect^o^f^In^cre^a^sed^Acces^{s t}^o^E^m^ergen^c^y^Coⁿ^t^racep^tⁱ^oⁿ^A^m^oⁿ^g^Y^oung^A^dole^s^c^eⁿ^ts^,”
^Ob^st^et^ri^{cs a}ⁿ^d^Gyn^eco^l^o^g^y^{, v}^.¹⁰⁶^{, Se}^p^t^e^m^be^r²⁰⁰⁵^{, p}^p^.⁴⁸^3-⁴⁹¹^.
³⁰^{U.S. C}^ong^re^{ss, Se}^na^te^Com^m^itte^e^{on He}^a^lth^{, Ed}^uc^a^tio^n,^L^a^{bor a}ⁿ^d^P^e^nsi^ons,^Nomⁱ^na^ti^on^of^L^e^ste^r^{M. Cra}^w^f^o^rd,
^Heariⁿ^g,¹⁰⁹^th^Con^g^ress,¹^st^s^e^s^s^.^,^Ma^r^c^{h 1}⁷^,²⁰^05,^p.¹⁶^.
³¹^I^C^{F I}ⁿ^te^rⁿ^a^tio^na^{l, C}^o^m^m^eⁿ^{t Sum}^m^a^r^y^o^f^FD^A^’^s^A^d^v^a^nc^e^d^N^o^tic^e^of^a^P^r^o^pos^e^d^R^u^le^m^a^kⁱ^ng^{on Se}^pte^m^be^r^{1, 20}⁰⁵^,
^D^r^ug^A^ppr^ov^a^l^s^:^Cⁱ^r^c^um^s^t^aⁿ^c^e^s^unde^r^w^h^ic^{h a}ⁿ^A^c^tiv^e^Iⁿ^g^r^e^d^ie^nt^Ma^y^B^e^Sim^u^lta^ne^ous^ly^Ma^r^k^e^t^{ed in}^B^o^t^h^a
^P^r^e^s^c^r^iptⁱ^oⁿ^D^r^ug^P^r^od^uc^{t a}ⁿ^d^aⁿ^O^v^e^r^-^t^he^-^c^ounte^r^D^r^ug^P^r^od^uc^t,^Ma^y^{19, 20}^06.^D^o^c^u^m^e^{nt f}^oun^{d a}^t
^http:^//w^w^w^.f^da^.g^ov^/^o^c^/^plaⁿ^b^/^s^u^m^m^a^r^y⁰⁵¹⁹⁰^6.^htm^l^.
³²^P^e^titio^{n f}^o^u^{nd a}^t^htt^p^://c^li^ntoⁿ^.s^eⁿ^a^t^e^.^g^o^v^/^ne^w^s^/^s^ta^tem^e^nts^/^de^ta^ils^.c^fm^?ⁱ^d=²⁴⁸⁰⁸⁵^aⁿ^d^htt^p^://m^urra^y^.^s^e^na^te^.g^ov^/
^ne^w^s^.cf^m^?ⁱ^d=²⁴⁸⁰⁹^4.

the decision,” stated the GAO. The GAO urged Health and Human Services Secretary Mike
Leavitt to assure that an upcoming decision about the pill’s status “is based on the best available
science instead of ideology.”
In July 2006, FDA stated that it had evaluated the public comments and decided that it could
proceed without creating a new regulation to allow the drug to be offered without a prescription
to adults. Barr resubmitted its OTC application to FDA in mid-August 2006 and FDA approved
the switch to OTC on August 24, 2006. The manufacturer agreed to the use of anonymous
shoppers to test compliance with the age restriction. Barr also agreed that a booklet will be
distributed with the drug that explains proper use of the drug. The age restriction was changed
from 17 to 18 because it is the “age of majority” and sales of nicotine replacement treatments ³³
(gum and patch) are allowed at 18 years of age. In approving nicotine replacement treatments
for OTC sales, FDA also restricted sales to individuals 18 and over.

At least three lawsuits have been filed with regard to the FDA’s approval of Plan B, or the ³⁵
approval process itself. In Tummino v. von Eschenbach, representatives of several reproductive
health organizations filed a complaint against FDA Commissioner Andrew von Eschenbach, on
behalf of women seeking emergency contraception. The suit was filed on January 21, 2005, over
a year and a half before the FDA announced its approval of the OTC switch for Plan B for women ³⁶
18 and older. The case has yet to go to trial. In light of the FDA’s bifurcated approval, the
plaintiffs amended their filing and asked the court to require the FDA to approve Plan B for all
ages, remove the agency’s requirement that pharmacists keep Plan B behind the counter, and ³⁷
allow all businesses to sell Plan B.
The plaintiffs, some as young as 13, argue that the FDA did not follow proper agency procedures ³⁸
when it mandated age and point-of-sale restrictions for Plan B. Because the drug is used only by
women, they contend that the FDA engaged in sex discrimination in violation of the Fifth
Amendment right to Equal Protection. The plaintiffs also assert that the agency violated their
Fifth Amendment right to privacy “without serving any compelling, significant, or even
legitimate government interest” by restricting access to certain ages, the location of the drug

³³^Me^m^o^ra^ndum^{, A}^ndrew^v^{on Es}^c^h^e^nba^c^h^{, FD}^A^A^c^ting^Com^mⁱ^s^sⁱ^one^{r, A}^u^g^u^s^t^23,²⁰⁰⁶^htt^p^://w^w^w^.^f^da^.g^ov^/c^de^r/
^dr^ug^/ⁱ^nf^opa^g^e^/^p^la^nB^/^a^v^e^m^e^m^o^.pdf^.
³⁴^T^h^{is se}^c^{tion w}^a^s^w^r^itte^{n by}^V^a^ne^ssa^{K. Burrow}^s^{, Am}^e^r^ic^aⁿ^La^w^Dⁱ^vⁱ^{sion, CR}^S.
³⁵^N^o^.^05-³⁶^{6 (}^E^.D^.N^.Y^{. f}^ile^{d J}^a^nu^a^r^y^{21, 2}⁰⁰⁵⁾^.^L^e^s^t^e^r^{M. C}^r^a^w^f^o^r^d^{, f}^o^r^m^e^r^A^c^ting^C^o^m^m^is^sⁱ^one^r^of^the^FD^A^,^w^a^s
^the^or^ig^ina^l^na^m^e^{d de}^f^e^nda^nt.
³⁶^T^h^e^Sta^t^e^of^Wⁱ^s^c^ons^{in f}^ile^{d a}^m^o^tioⁿ^on^Ma^r^c^{h 2}⁰^,²⁰⁰⁶^s^e^e^k^ing^{to be}^na^m^e^{d a}^s^aⁿ^a^dditi^ona^l^plaⁱ^ntif^f^.^T^h^e^s^t^a^t^e
^ci^t^e^dⁱ^t^sⁱⁿ^t^e^rest^{s i}ⁿ^p^r^egn^aⁿ^t^t^{eenagers an}^d^ad^o^l^escen^t^m^o^t^h^ers,ⁱⁿ^cu^rren^t^and^po^t^eⁿ^tⁱ^a^l^M^e^dⁱ^cai^{d b}^eⁿ^e^fⁱ^ci^ari^e^s,ⁱⁿ
^en^su^riⁿ^g^al^l^chi^l^d^{ren bo}^rnⁱⁿ^t^h^{e s}^t^at^{e are wan}^t^ed^chⁱ^l^d^reⁿ^,^andⁱⁿ^re^d^u^cⁱⁿ^{g t}^h^{e nu}^m^b^{er o}^f^ab^o^r^tⁱ^oⁿ^s^an^d^uⁿ^w^an^t^e^d
^bir^t^hs^.^Wⁱ^s^c^ons^in’^s^m^o^tio^{n to}ⁱⁿ^te^r^v^eⁿ^e^w^a^s^de^nie^d^.
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^sal^eⁱⁿ^l^o^catⁱ^oⁿ^s^su^c^h^{as su}^p^e^rm^ar^ket^s^,^{gas st}^atⁱ^oⁿ^s^,^o^r^con^v^enⁱ^eⁿ^{ce st}^o^r^es.^Id^.^a^t³⁴^.^Plaⁿ^B^c^aⁿ^on^ly^be^dis^t^rⁱ^bute^d
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^N^E^W^S^/200^6/^N^E^W⁰¹⁴³^6.htm^l^.
³⁸^N^o^.^05-³⁶^6,^pp.³⁵^-³^{9 (}^f^if^{th am}^ende^{d c}^o^m^p^la^{int f}^ile^{d O}^c^tobe^r^10,²⁰⁰⁶⁾^.

behind the counter, and sales in certain businesses.³⁹ Next, the plaintiffs object to alleged
violations of the right to informational privacy that will occur because they must disclose their
ages and possibly other information, such as names and addresses, to obtain Plan B from behind
the counter. The plaintiffs view this as a “disclosure of information to third parties about [their] ⁴⁰
personal sexual activity.” Finally, the plaintiffs contend that the agency ignored certain ⁴¹
requirements under the Administrative Procedure Act (APA).
With regard to the alleged APA violations, the plaintiffs specifically argue that the agency’s
imposition of age and point-of-sale restrictions was arbitrary, capricious, and an abuse of agency
discretion. The FDA allegedly required greater information for the approval of Plan B than the ⁴²
agency required for past approvals of OTC medications. Additionally, the plaintiffs argue that
the FDA had enough data regarding Plan B’s safety and effectiveness to make the drug available ⁴³
OTC without further restrictions. The plaintiffs also contend that the agency took improper
action when determining age restrictions for Plan B, despite recommendations within the agency ⁴⁴
that the FDA approve Plan B without age limits. According to the lawsuit, the FDA also violated
the APA by overstepping its statutory mandate in two ways. First, the FDA’s denial was
purportedly influenced by logic other than scientific or medical evidence:
^S^w^o^rⁿ^d^e^p^o^s^itioⁿ^s^ta^k^eⁿ^b^y^l^a^w^y^er^s^f^r^o^m^th^e^Ceⁿ^t^er^f^o^r^Rep^r^o^d^u^ctiv^e^Ri^g^h^t^{s, a le}^g^a^l
^adv^o^cac^y^org^aⁿⁱ^zatioⁿ^,^s^h^o^w^t^h^{at s}^o^m^e^of^t^h^{e [FD}^A^]’s^s^t^a^f^f^m^e^m^b^ers^w^e^{re conv}ⁱⁿ^{ced th}^a^t
ⁿ^o^a^m^oun^{t of}^s^c^ienti^f^{ic ev}^ideⁿ^ce^w^o^u^l^d^h^a^v^e^pers^u^a^{ded th}^{e [FD}^A^]’s^{political appoin}^t^ees^to
^a^p^p^r^o^v^e^t^h^e^a^p^p^lⁱ^c^a^tⁱ^o^n.^D^r^.^J^{ohn J}^eⁿ^kⁱⁿ^s,^dⁱ^r^e^c^t^o^r^o^f^t^h^e^O^f^fⁱ^c^e^o^f^N^e^w^D^r^ug^s^at^t^h^e^ag^eⁿ^c^y^,
^saidⁱⁿ^{a d}^e^p^o^s^itioⁿ^t^h^at^hⁱ^{s b}^o^{ss, Dr}^.^Ste^v^en^Galsoⁿ^{, to}^ld^hⁱ^m^“^t^h^a^t^h^e^f^e^lt^h^e^dⁱ^dⁿ^’^t^h^a^v^e^a⁴⁵
^ch^{oice” bu}^{t to rej}^{ect th}^{e applic}^ation^.
Second, the plaintiffs assert that “the FDA lack[ed] the statutory authority to restrict the types of
businesses that can sell OTC drugs,” and the “authority to control the point of sale of ⁴⁶
nonprescription drug products.”
In response to the amended complaint, the FDA moved to dismiss the case on the grounds that (1)
the court lacks jurisdiction, (2) the plaintiffs do not have standing to bring the case, (3) the
complaint’s allegations fail to state a claim for which the court may grant relief, (4) the plaintiffs’ ⁴⁷
claims are moot, and (5) the court lacks the authority to grant the requested relief.
Furthermore, the FDA acknowledged that it has received at least four citizens petitions on Plan B ⁴⁸
and denied at least one. The FDA also admitted that, for the ten years prior, the agency either

³⁹^Id^.^a^t³⁸^{, 4}¹^.
⁴⁰^Id^.^a^t^{6, 41-}⁴²^.
⁴¹^Id^{. a}^t^2;^{5 U}^.^S^.^C^.^{§ 7}⁰⁶⁽¹⁾^-⁽²⁾⁽^a⁾^,⁽^c⁾^.
⁴²^N^o^.^05-³⁶^6,^pp.³⁵^-³^{6 (}^f^if^{th am}^ende^{d c}^o^m^p^la^{int f}^ile^{d O}^c^tobe^r^10,²⁰⁰⁶⁾^.
⁴³^Id^.^a^t⁴⁰^.
⁴⁴^Id^{. a}^t^31-³³^.
⁴⁵^G^a^r^d^ine^r^H^a^r^rⁱ^s^,^“^F^D^A^A^ppr^ov^e^s^B^r^oa^de^r^A^c^c^e^s^s^{to N}^e^x^t^-^D^ay^P^ill^,”^{New Yo}^{rk Times}^{, A}^u^g^u^s^t²⁵^{, 2}⁰^06,^{p. A}¹^.
⁴⁶^N^o^.^05-³⁶^6,^pp.¹³^,^{40 (}^f^if^{th a}^m^ende^{d c}^o^m^p^la^{int f}^ile^{d O}^c^tobe^r^10,²⁰⁰⁶⁾^.
⁴⁷^N^o^.^05-³⁶^6,^p.^{33 (}^a^ns^w^e^r^{to f}ⁱ^f^t^{h a}^m^e^nde^{d c}^o^m^p^la^{int f}^ile^{d Ma}^r^c^h^5,²⁰⁰⁷⁾^{. T}^h^e^de^f^e^nda^{nt d}ⁱ^d^not^h^a^v^e^{to f}^ile^aⁿ
^an^sw^{er t}^o^t^h^{e p}^l^ai^ntⁱ^f^f^s^’^f^o^u^r^t^h^amen^d^e^d^co^m^p^l^aⁱⁿ^t^b^ecau^{se t}^h^{e F}^D^A^ap^p^r^o^v^ed^P^l^an^{B f}^o^{r i}ⁿ^dⁱ^vi^dual^s¹⁸^and^o^l^d^e^r
^b^e^f^o^{re t}^h^{e d}^ead^lⁱⁿ^e^f^o^{r t}^h^{e d}^e^f^eⁿ^d^an^t^’^{s an}^sw^er.
⁴⁸^Id^{. a}^t^p.¹¹^{. T}^h^e^FDA^a^llow^s^c^iti^z^eⁿ^{s to pe}^ti^tio^{n f}^o^{r a}^sw^itc^{h of}^a^drug^f^r^o^m^pre^s^c^r^iption^to^OT^{C sta}^t^{us. 2}¹^C.^F.R.
³¹⁰^.2⁰⁰⁽^b)^.

approved applications for OTC status after its advisory committee recommended granting the ⁴⁹
applicant OTC status, or the agency did not reach a final determination on the application. The
FDA said that in those ten years, it requested subsequent information on teen use not only for
Plan B, but also for OTC nicotine replacement therapies, and noted that several past supplemental
new drug applications included information on teen use of prescription drugs when requesting ⁵⁰
OTC status. In addition, the FDA specifically denied that it created a behind-the-counter ⁵¹
“regime” for Plan B and that the FDA mandated that it be kept behind-the-counter.
In response to the plaintiffs’ suggestions that the FDA’s Plan B review procedures were
politicized and unusual, the agency initially claimed that privilege protected it from discussing its
deliberative process, including advice, opinions, and ideas received by the agency and presented ⁵²
by those involved in the process. In an amended answer, the FDA later stated that such
allegations were irrelevant and immaterial to the complaint’s causes of action, as well as beyond ⁵³
the court’s jurisdiction. Notably, scientific data reviewed by the FDA’s Center for Drug
Evaluation and Research determined that Plan B could be safely used by women age 17 and ⁵⁴
older.
As noted above, the suit was filed before the FDA approved the application to switch Plan B to
OTC status for women ages 18 and older, but the plaintiffs are currently pursuing the case with
respect to women younger than 18. Most recently, the plaintiffs have asked for summary
judgment, a request made because, allegedly, no material issues of fact exist and thus the
plaintiffs are entitled to a judgment in their favor.
In Judicial Watch, Inc. v. FDA,⁵⁵ the conservative non-profit sued the FDA for violating the
Freedom of Information Act with regard to the agency’s communications with Members of
Congress about Plan B. The relevant provision of that Act requires that the agency, upon
receiving a request for records, decide whether it will comply with such request within 20 ⁵⁶
business days after receiving such request. Judicial Watch had requested records of any and all
communications between the FDA and Senators Clinton, Murray, and Enzi and their staff
members with regard to Plan B. The FDA filed a motion to dismiss, noting that it had “produced ⁵⁷
all responsive records,” which the agency argued renders the case moot because “it gives the

⁴⁹^Se^e^N^o^.^05-³⁶^6,^p.²⁹⁽^a^ns^w^e^r^{to f}ⁱ^f^t^{h am}^e^nde^{d c}^o^m^p^la^{int f}^ile^{d Ma}^r^c^{h 5,}²⁰⁰⁷⁾⁽^r^e^f^e^r^e^nc^ing^a^le^tte^r^f^r^o^m^f^o^r^m^e^r
^FDA^Co^mm^issioⁿ^e^{r L}^e^st^{er Cra}^w^fo^rd^).
⁵⁰^Id^.^a^t²⁴^{. T}^h^e^FD^A^a^l^s^o^note^d^th^a^t^the^da^ta^r^e^q^u^ir^e^d^f^o^r^O^T^C^a^ppr^ov^a^l^de^peⁿ^d^s^oⁿ^the^pr^o^duc^t^.^Id^.^a^t³⁰^.
⁵¹^Id^.^a^t^2,²⁸^{. T}^h^e^q^u^e^s^tion^a^s^{to w}^h^e^t^he^r^t^h^e^FD^A^ha^s^c^r^e^a^t^e^d^a^thir^{d c}^l^a^s^s^of^be^hin^d^-^t^he^-^c^oun^te^r^dr^u^g^s^—ⁱ^{n a}^dditi^on^to
^pr^e^s^c^r^iptio^{n d}^r^ug^s^aⁿ^d^O^T^C^dr^ug^s^—^is^c^ontr^o^v^e^r^s^ia^l.^S^{ee i}ⁿ^f^r^a^t^e^xt^acco^m^p^an^yⁱⁿ^gⁿ^o^t^{es 63}^t^o⁶⁷^;^Iⁿ^sⁱ^d^e^W^a^shⁱⁿ^gt^oⁿ
^Publ^is^he^r^s^,^FDA^Polic^y^C^h^ie^{f Re}ⁱ^gnite^{s De}^b^a^te^ov^e^r^Th^{ird Dru}^g^Cl^ass^{, FD}^A^W^e^e^k^{, Ma}^y^{18, 2}⁰⁰⁷^.
⁵²^N^o^.^05-³⁶^6,^p.^11-^{12 (}^a^ns^w^e^r^{to thir}^{d a}^m^e^nde^{d c}^o^m^p^la^{int f}^ile^{d Fe}^b^r^ua^r^y^{14, 20}⁰⁶⁾^{. A}^s^a^pr^e^lim^ina^r^y^m^a^tte^r^,^the
^plaⁱ^ntif^f^s^f^ile^{d a}^{nd a}^m^a^gⁱ^s^t^r^a^te^judg^e^g^r^aⁿ^te^{d the}ⁱ^r^m^o^tio^{n s}^e^e^k^ing^dis^c^ov^e^r^y^of^doc^um^eⁿ^ts^w^ithhe^{ld unde}^r^the
^de^libe^r^a^tiv^e^pr^oc^e^s^s^pr^iv^ile^g^e^{. T}^h^e^judg^e^a^l^s^o^de^nie^d^t^h^e^FD^A^’^s^r^e^que^s^t^f^o^r^a^pr^ote^c^tiv^e^or^de^r^qua^s^h^ing^dis^c^ov^e^r^y^or
^a^lte^rⁿ^a^tiv^e^l^y^“^aⁿ^or^de^r^pr^ohi^bitiⁿ^g^dis^c^ov^e^r^y^f^r^om^the^W^h^ite^H^ous^e^,^”^a^s^he^ha^d^do^neⁱⁿ^Fe^br^ua^r^y²⁰^{06 w}^{ith a}^pr^e^v^ious
^FD^A^r^e^que^s^t^f^o^r^a^pr^ote^c^tiv^e^or^de^r^pr^e^v^eⁿ^ting^dis^c^ov^e^r^y^.^N^o^{. 05}^-³⁶⁶^{, p}^p^.^1,^{5 (}^D^e^cⁱ^sⁱ^oⁿ^aⁿ^{d O}^r^de^r^,^N^o^v^e^m^b^e^r^11,
²⁰⁰⁶⁾^.^T^h^{e F}^D^A^ap^p^eal^ed^t^h^{e m}^a^gi^st^rat^e^{’s d}^eci^si^oⁿ^on^Dece^m^b^{er 1}^,²⁰⁰⁶^.
⁵³^N^o^.^05-³⁶^6,^p.^14,¹⁶⁽^a^ns^w^e^r^to^fⁱ^f^t^{h am}^e^nde^{d c}^o^m^p^la^{int f}^ile^{d Ma}^r^c^{h 5,}²⁰⁰⁷⁾^.
⁵⁴^Id^{. a}^t¹⁸^.
⁵⁵^N^o^.^07-⁰⁵^{61 (}^D^.D^.C^{. f}^ile^{d Ma}^r^c^{h 2}¹^,²⁰⁰⁷⁾⁽^p^laⁱⁿ^tif^f^’^s^am^e^nde^d^c^o^m^p^la^int)^.
⁵⁶⁵^U.S^.^C.^§⁵⁵²⁽^a)(⁶^)(A^)(i).
⁵⁷^N^o^.^07-⁰⁵^61,^p.^1,^{8 (}^D^.D^.C^{. f}^ile^{d J}^u^ly^16,²⁰⁰⁷⁾⁽^m^em^or^a^ndum^of^law^{in s}^upp^or^t^of^de^f^e^nda^nt’^s^m^o^tio^{n t}^o^dⁱ^s^m^is^s
^or^{, i}ⁿ^t^h^e^a^lte^rⁿ^a^tiv^e^,^f^o^r^s^u^m^m^a^r^y^judgm^eⁿ^t)^.

requester the relief sought in the FOIA complaint.”⁵⁸ Alternatively, the FDA moved for summary
judgment on the issue of the adequacy of the agency’s records of its communications with the
Senators and their staff members, asserting that its search was adequate and “reasonable as a ⁵⁹
matter of law.” These motions are pending before the federal district court for D.C.
In Association of American Physicians & Surgeons, Inc. v. FDA,⁶⁰ a not-for-profit organization
representing physicians in typically small or solo practices and three conservative women’s and
reproductive health groups filed suit seeking to overturn the FDA’s approval of Plan B as an OTC
drug so that the drug would become available, again, only by prescription. First, the plaintiffs
argue that Plan B is unsafe for OTC distribution because the label “does not adequately warn
consumers of Plan B’s ineffectiveness for routine contraception” and because information
submitted to the FDA in support of the change to an OTC drug did not “establish either Plan B’s ⁶¹
safety or effectiveness.” Second, the plaintiffs allege that the FDA lacked the authority to
approve a drug both OTC and as a prescription because the Federal Food, Drug, and Cosmetic
Act (FFDCA) does not authorize approval or distribution of the same drug for sale both OTC and
as a prescription. Third, citing the FDA’s inability to enforce age restrictions and alleged errors in
waiving pediatric research requirements, the complaint asserts that the FDA could not lawfully
“bifurcate a drug product’s OTC versus Rx status based on the patient’s age,” under the ⁶²
FFDCA. Fourth, the plaintiffs assert that the FDA does not have the power to create a new, third
class of drugs, those “that require pharmacists to supplement the labeling or that certain ⁶³
subpopulations might misuse with direct access.” Next, the plaintiffs assert that the FDA did not
engage in the necessary rulemaking under the APA when amending its interpretation of a ⁶⁴
statutory provision to approve Plan B as an OTC drug. In addition, the plaintiffs allege that the
FDA did not follow the FFDCA when it removed Plan B from prescription status without a ⁶⁵
rulemaking. Finally, they argue that the FDA unlawfully approved Plan B as an OTC drug ⁶⁶
“under improper pressure from Senators Clinton and Murray.” As a result, according to the
plaintiffs, the FDA’s approval of Plan B and the agency’s avoidance of the rulemaking process
was arbitrary and capricious.
In response, the FDA moved to dismiss the suit on five grounds: (1) the plaintiffs lack standing to
challenge the FDA’s approval decision of Plan B’s supplemental new drug application, (2) the
court lacks subject matter jurisdiction to review the FDA’s approval of the Plan B supplemental
new drug application, (3) the plaintiffs failed to state a claim as far as their allegations that the
FDA lacked the authority to approve Plan B both OTC and as a prescription drug and that the
FDA did not have the power to create a third class of behind-the-counter drugs, (4) the plaintiffs’
contentions that the FDA violated the APA and the FFDCA by failing to engage in a rulemaking
were incorrect as a matter of law, and (5) FDA Commissioner Von Eschenbach was improperly

⁵⁸^Id^.^at⁹^.
⁵⁹^Id^.^a^t^{2, 11-}¹²^.
⁶⁰^N^o^.^07-⁶⁶^{8 (D}^.D^{.C. f}^ile^{d A}^p^ril¹²^{, 2}⁰⁰⁷^).
⁶¹^N^o^.^07-⁶⁶^8,^p.^{25 (}^D^.D^.C^{. f}^ile^d^A^p^r^{il 12,}²⁰⁰⁷⁾⁽^p^laⁱⁿ^tif^f^s^’^c^o^m^p^la^{int f}^o^r^de^c^l^a^r^a^t^or^y^a^{nd inj}^unc^tiv^e^r^e^lie^f⁾^.
⁶²^Id^.^a^t^{2, 26-}²⁸^.
⁶³^Id^.^a^t²⁸^.
⁶⁴^Id^.^at²^-^3,²⁹^.
⁶⁵^Id^.^a^t^29-³⁰^.
⁶⁶^Id^.^a^t^{2, 30-}³¹^.

named as a defendant in his individual capacity because the plaintiffs’ claims related to official ⁶⁷
FDA actions. The case has yet to go to trial.

About half the states have adopted policies that affect access to emergency contraceptives.
Several states have passed pharmacy access laws that allow women to obtain emergency ⁶⁹
contraception directly from a pharmacy without first going to a doctor or clinic. With the FDA’s ⁷⁰
decision, these measures will now apply only to minors. Plan B is available from pharmacists,
without a physician’s prescription, under certain conditions in the following nine states: Alaska,
California, Hawaii, Maine, Massachusetts, New Hampshire, New Mexico, Vermont, and ⁷¹
Washington. In these states, pharmacists are allowed to sell emergency contraception to women
who ask for the product. After speaking with the woman, the pharmacist determines if emergency
contraception is appropriate. In order to participate, the pharmacy and the pharmacist must fill out
application forms and undergo training. Access is still limited in these states by the number of
pharmacies that participate.
Several states have laws that specifically pertain to emergency room practices with respect to
emergency contraceptives. For example, in seven states—California, Massachusetts, New Jersey,
New Mexico, New York, South Carolina, and Washington—hospital emergency rooms must
dispense emergency contraceptives upon request to sexual assault victims; similar policies in
Ohio and Oregon do not have an enforcement mechanism. In May 2007, Governor Jodi Rell
signed into law a measure that requires all hospitals in Connecticut, including Catholic hospitals, ⁷²
to provide emergency contraception to rape victims; the law takes effect on October 1 2007.
Emergency rooms must provide information about emergency contraceptives in 10 states:
Arkansas, California, Colorado, Illinois, Massachusetts, New Jersey, New Mexico, New York,
Texas, and Washington. A similar policy in Ohio does not have an enforcement mechanism.
Several states have enacted laws regarding pharmacists who refuse to dispense birth control and ⁷³
emergency contraception. These laws vary widely from state to state. Four states (Arkansas,
Georgia, Mississippi, and South Dakota) explicitly allow pharmacists to refuse to dispense
contraceptives, including emergency contraceptives. In five states (Colorado, Florida, Illinois,

⁶⁷^N^o^{. 07-}⁶⁶^{8, p. 10,}²⁵^{, 31,}³⁸^{, 41 (}^d^e^f^e^nda^nt’^s^m^o^tion^t^o^dis^m^is^s^f^ile^d^J^une^29,²⁰⁰⁷⁾^.
⁶⁸^Ex^c^e^p^{t f}^o^r^the^Me^dic^aⁱ^d^c^o^v^e^r^a^ge^dis^c^us^sⁱ^on^a^t^the^e^nd^of^this^s^e^c^tion,^theⁱⁿ^f^o^r^m^a^{tion c}^ontaⁱ^ne^{d i}ⁿ^this^s^e^c^tion^w^a^s
^la^rg^e^l^y^f^{ound i}ⁿ^t^h^e^f^o^llowⁱ^ng^pu^blic^a^tio^{n: G}^u^ttm^a^c^h^e^r^Ins^titute^{, “}^S^ta^te^s^Polic^ie^sⁱⁿ^Brie^f^—^E^m^e^r^genc^y^Contr^acep^tⁱ^oⁿ^,^”
^Ju^ly¹^,²⁰⁰⁷^h^t^t^p^://w^ww^.^g^u^ttm^a^c^h^er.o^rg^/^s^tatecen^ter/^sp^ib^s/^sp^ib^_^E^C^.^p^d^f^.
⁶⁹^A^lthoug^{h FD}^A^ha^s^the^a^u^th^or^ity^{to de}^te^r^m^ine^the^s^t^a^t^us^f^o^r^m^e^dic^a^tions⁽^O^T^C^or^pr^e^s^c^r^ipti^on)^,^s^t^a^t^e^s^ha^v^e^the
^au^t^h^o^rⁱ^t^y^t^o^d^e^t^e^rmⁱⁿ^{e w}^h^o^m^a^y^p^r^escri^b^{e p}^r^escri^p^tⁱ^oⁿ^m^e^dⁱ^catⁱ^oⁿ^s^.^P^h^arm^a^c^y^acc^{ess l}^a^w^s^re^f^l^e^c^t^t^h^{e cu}^rren^t
^p^r^escri^p^tⁱ^oⁿ^st^at^u^s^f^o^r^P^l^an^B,^{as d}^e^t^e^rmⁱⁿ^ed^b^y^t^h^{e F}^D^A^h^t^t^p^:^/^/^www^.^p^h^a^r^m^ac^yacc^ess.^o^r^g/^p^d^f^s/
^P^h^arm^aci^st^F^A^Q^s^OT^C.^p^d^f^.
⁷⁰^A^c^co^rdⁱⁿ^{g t}^o^S^t^even^G^a^l^s^oⁿ^,^Di^r^ect^o^r^o^f^t^h^{e F}^D^A^Cen^t^{er f}^o^{r Dru}^g^E^v^al^u^a^tⁱ^o^{n an}^{d Research}^,^t^h^e^P^l^aⁿ^{B OT}^C
^de^cⁱ^{sion w}^{ill n}^o^{t e}^f^f^e^c^t^the^s^e^sta^t^e^re^g^u^la^{tions t}^h^a^t^a^l^l^o^w^the^drug^t^o^be^dis^p^eⁿ^se^{d w}^itho^u^t^pre^s^c^r^iptio^{n to}^pe^o^p^le^of^a^ll
^a^g^e^s^{. R}^ita^R^ubin,^“^F^D^A^A^ppr^ov^e^s^O^v^e^r^-^T^he^-^C^ounte^r^Sa^le^s^of^P^l^aⁿ^B^,^”^US^{A T}^o^da^y^{, A}^u^g^u^s^t²⁵^,²⁰⁰⁶^{, p. A}²^.
⁷¹^Iⁿ^a^d^diti^on,^a^f^e^w^pha^r^m^ac^is^ts^{in Monta}ⁿ^a^pr^ov^ide^P^l^aⁿ^B^u^nde^r^c^o^lla^bor^a^tiv^e^a^g^r^e^em^eⁿ^t^w^{ith phy}^sⁱ^cⁱ^aⁿ^s^.^N^O^T^-²^-
^LAT^E^.co^m^{, th}^{e Em}^erg^eⁿ^c^y^Coⁿ^t^racep^tioⁿ^W^e^b^s^{ite h}^t^tp^://ec.^p^rⁱⁿ^cet^oⁿ^.^ed^u^/^q^u^e^stioⁿ^s^/^w^h^a^t-^f^d^a-sa^y^s^.h^tm^l.
⁷²^Hila^ry^W^a^ld^m^a^{n, “}^R^e^{ll Sig}ⁿ^s^P^l^aⁿ^{B L}^a^w^;^Chaⁿ^g^e^{s Still}^P^o^ssible^,^”^The^H^a^r^t^f^o^r^d^C^our^ant^{, Ma}^y^17,²⁰⁰^7.
⁷³^For^f^u^r^t^he^r^inf^o^r^m^a^{tion, s}^e^e^C^R^S^R^e^por^{t R}^S²²²^93,^Fe^de^r^a^{l an}^{d St}^ate^Law^s^Re^gar^din^g^P^har^m^a^cⁱ^s^t^s^W^ho^Re^fus^e^t^o
^Di^st^ri^b^u^t^{e C}^oⁿ^t^ra^ceptⁱ^ves^{, by}^J^ody^Fe^de^r^.

Maine, and Tennessee), a broadly worded refusal policy may apply to pharmacists or pharmacies,
but does not specifically include them. In Illinois, however, pharmacies that stock contraceptives
must also dispense emergency contraceptives. In the state of Washington, a recent rulemaking by
the state’s Board of Pharmacy requires pharmacy owners to ensure that if one pharmacist refuses
to fill a prescription, another pharmacist will deliver the lawfully prescribed drug or device to the ⁷⁴
patient. If a prescription drug or device is out-of-stock, the new rule provides several options to
the patient, including transmitting the patient’s prescription to another pharmacy, chosen by the ⁷⁵
patient, that will fill the prescription. The Washington State regulations are being challenged in
federal district court by the parent corporation of two grocery stores, including one that has a
pharmacy, and two pharmacists who are the sole pharmacists on duty at pharmacies that allegedly ⁷⁶
could not hire another pharmacist to dispense drugs such as Plan B.
On March 20, 2006, all Wal-Mart pharmacies began stocking and filling prescriptions for Plan B.
Prior to that date, the company only stocked and filled prescriptions for the drug at its pharmacies
in Massachusetts and Illinois where it was required by law. The company decided to change its
policy because Wal-Mart expects more states to require Plan B to be available for sale. “Because
of this, and the fact that [Plan B] is an FDA-approved product, we feel it is difficult to justify ⁷⁷
being the country’s only major pharmacy chain not selling it.” The company intends to keep its
“conscientious objection” policy, which allows pharmacists to refuse to fill prescriptions and refer
patients to another pharmacy or pharmacist. There are more than 3,700 Wal-Mart pharmacies
nationwide.
Connecticut Attorney General Richard Blumenthal announced on March 4, 2006, that state health
plans would not cover prescriptions from pharmacies that do not stock Plan B. Attorney General
Blumenthal said that his decision to remove pharmacies from the state’s health plan coverage
would remain until he is certain “every pharmacy will dispense [Plan B] wherever it is medically ⁷⁸
prescribed.”
There is great variation among the states regarding emergency contraception coverage for ⁷⁹
Medicaid beneficiaries. Following the August 2006 FDA decision, 16 states have implemented
written policies to address coverage of emergency contraception as an OTC drug. Most of the
remaining states had policies on emergency contraception coverage prior to August 2006, and
those policies remain in effect. Because the billing procedures of most state Medicaid programs
require the pharmacist to submit a prescription in order to be reimbursed for OTC drugs, low-
income women must either obtain a prescription or pay the $40 out-of-pocket cost. In nine states
(Alabama, Arizona, Idaho, Indiana, Kentucky, Maryland, Nevada, North Carolina, Rhode Island)
prior authorization is required for emergency contraception reimbursement. The dual status of

⁷⁴^Se^e^W^a^s^h^{. A}^d^mⁱ^{n. C}^ode²⁴^6-⁸⁶⁹^-⁰¹^0,²⁴^6-⁸^63-⁰⁹^{5; N}^e^w^s^R^e^le^ase^,^W^a^s^h^ing^t^{on Sta}^t^e^D^e^pa^r^t^m^e^{nt of}^H^e^a^lth,
^P^h^a^r^ma^{cy Di}^sp^en^siⁿ^g^R^u^l^e^{s g}^oⁱⁿ^t^o^E^f^f^ect^Jul^y²⁶^(J^uly^17,²⁰⁰⁷^{) h}^ttp://w^w^w^.doh.w^a^.g^ov^/^P^u^b^lic^a^t^/²⁰⁰⁷^_ne^w^s^/07-
¹¹⁶^.htm^.
⁷⁵^W^a^s^h^{. A}^d^mⁱ^{n. C}^ode²⁴^6-⁸^69-⁰¹^0.
⁷⁶^Stor^m^a^ns^{, I}ⁿ^c^.^v^.^Se^le^c^k^{, N}^o^.⁰⁷^-⁵³⁷^4,^p.¹⁰^{, 1}²⁽^W^.D^.W^a^s^{h. f}^ile^{d J}^u^ly^{25, 2}⁰⁰⁷⁾^.^T^h^e^p^l^aⁱ^ntif^f^s^a^lleg^e^vⁱ^ola^tions^of
^t^h^{e eq}^u^a^l^p^r^ot^ectⁱ^o^{n an}^{d su}^p^r^em^a^c^y^cl^au^{ses o}^f^t^h^{e U.}^S^.^Coⁿ^s^tⁱ^t^u^tⁱ^on^,^{as w}^e^l^l^{as vi}^o^l^atⁱ^oⁿ^s^o^f^t^h^ei^{r ri}^gh^t^s^t^o^f^r^{ee ex}^erci^se
^of^r^e^lig^{ion a}ⁿ^d^pr^oc^e^dur^a^l^due^pr^oc^e^s^s^.^Id^.^a^t^15-^17.
⁷⁷^Re^ute^r^{s, W}^a^l-Ma^{rt Pha}^r^m^a^cⁱ^e^s^{to Ca}^rr^y^Morniⁿ^g^-^Af^te^{r P}^ill,^Ma^rc^h^3,²⁰^01.
⁷⁸^Mⁱ^ch^{ael Barb}^aro^,^“In^Rev^e^{rsal, W}^a^l-M^a^{rt W}^{ill Sell Co}ⁿ^t^racep^tiv^es,”^{New Yo}^{rk Times}^,^Ma^r^c^{h 4, 20}^06.
⁷⁹^Iⁿ^f^o^r^m^a^{tion in t}^h^is^pa^r^a^g^r^a^{ph w}^a^s^f^{ound i}ⁿ^t^h^e^f^o^llowⁱ^ng^pu^blic^a^tⁱ^{on: N}^a^ti^ona^{l H}^e^a^lth^L^a^w^P^r^og^r^a^m^,^“^O^v^e^r^the
^Co^uⁿ^t^e^{r o}^r^O^u^t^o^f^Reach^?^A^Rep^o^r^t^on^E^vol^viⁿ^g^S^t^at^{e M}^e^dⁱ^cai^d^P^o^lⁱ^cⁱ^e^{s f}^o^{r Co}^veriⁿ^g^E^m^er^gen^c^y^Coⁿ^t^racep^tⁱ^oⁿ^,^”
^June²⁰⁰⁷^,^htt^p^://w^ww^.he^a^lthla^w^.^org^/^.

Plan B (OTC for women 18 and over, prescription-only for women under 18) is creating coverage
disparities.
^F^o^{r ex}^a^m^pl^{e, t}^h^{e G}^e^orgⁱ^{a Medi}^cai^{d prog}^ram^,^w^hⁱ^c^h^al^l^o^w^s^very^lⁱ^mⁱ^t^e^{d cov}^e^rag^e^f^o^{r O}^T^C
^d^r^ugs,^ha^{s r}^e^vi^se^dⁱ^t^s^p^r^o^vⁱ^d^e^r^maⁿ^u^a^l^t^o^e^x^c^l^ud^e^c^o^ve^r^a^ge^o^f^Pl^an^B^f^o^r^w^o^m^eⁿ¹⁸^an^d^ol^der
^w^hⁱ^l^e^c^o^ve^rⁱ^{ng t}^h^e^d^r^ug^fo^r^w^o^me^{n 1}⁷^aⁿ^d^und^e^r^w^h^o^ha^ve^a^d^o^c^t^o^r^’^s^pres^cri^p^tⁱ^oⁿ^.^A^r^k^aⁿ^s^a^s
^wi^l^l^c^o^v^e^r^t^w^o^t^a^b^l^e^t^s^p^e^r^p^r^e^s^c^rⁱ^p^tⁱ^oⁿ^.^Iⁿ^o^t^h^e^r^s^t^a^t^e^s^,^s^u^c^h^a^s^N^o^r^t^h^C^a^r^o^lⁱⁿ^a,^Medⁱ^caid^w^ill
^cov^e^{r [em}^e^r^g^en^c^y^con^t^raception^]^f^o^r^w^o^m^eⁿ^on^l^yⁱ^f^th^e^y^h^a^v^e^{a doctor’}^s^pres^criptⁱ^oⁿ^f^o^r^t^h^e⁸⁰
^dru^g^,^reg^a^rdl^e^s^s^o^f^t^h^ei^{r a}^g^e.
In Hawaii, Illinois, Maryland, New Jersey, New York, Oklahoma, Oregon, and Washington,
Medicaid will cover Plan B as an OTC drug for women over age 18 without the need for a ⁸¹
prescription. Mississippi, however, has decided to exclude emergency contraception from ⁸²
Medicaid coverage.

The National Violence Against Women Survey, which was conducted in 1996 and 1997, found ⁸³
that an estimated 300,000 women were raped in a single year. Based on an estimated 333,000
rapes occurring in 1998, as many as 25,000 pregnancies resulted due to rape in that year;
potentially 22,000 of such pregnancies could have been prevented if women had been provided ⁸⁴
with emergency contraceptive treatment.
The Office of Violence Against Women within the Department of Justice (DOJ) developed
guidelines for the treatment of sexual assault victims pursuant to Section 1405 of the Violence
against Women Act of 2000 (P.L. 106-386). The guidelines serve as an informational resource to
communities as they develop or revise their own procedures and do not invalidate any

⁸⁰^I^b^id^{., p. 5-}^6.
⁸¹^N^a^tiona^{l I}ⁿ^s^tit^ute^f^o^r^R^e^pr^o^duc^ti^v^e^H^e^a^{lth, “}^E^x^p^a^nding^Me^dic^aⁱ^d^C^o^v^e^r^a^g^e^f^o^r^EC^{on t}^h^e^Sta^t^e^L^e^v^e^l,”
^http:^//www^.proc^hoic^eⁿ^y^.^org^/^a^sse^t^s^/f^ile^s/^e^c^r^e^port.p^d^f^.
⁸²^Natⁱ^oⁿ^a^l^Heal^t^h^L^a^w^P^r^o^g^ram^,^“^O^{ver t}^h^{e Co}^uⁿ^t^e^{r o}^r^O^u^t^o^f^Reach^{? A}^Rep^o^r^t^oⁿ^E^v^o^l^viⁿ^g^S^t^at^{e M}^e^dⁱ^cai^d^P^o^lⁱ^cⁱ^e^s
^f^o^r^C^o^v^e^rⁱ^ng^Em^e^r^g^e^ncy^C^ontr^a^ce^ptio^n,”^J^u^ne²⁰⁰⁷^{, h}^ttp^:^//www^.he^a^lthla^w^.^org^/^{. A}^dditiona^{l i}ⁿ^f^o^rm^a^tion^oⁿ^Me^dic^aⁱ^d
^co^verag^e^o^f^e^m^ergen^c^y^coⁿ^t^racep^tⁱ^o^{n can}^b^e^f^o^un^dⁱⁿ^t^h^{e f}^o^l^l^o^wⁱⁿ^g^d^o^c^u^m^en^t^,^In^stⁱ^t^u^t^e^f^o^{r Rep}^r^o^d^u^c^tⁱ^v^{e Heal}^t^h
^A^c^c^e^{ss, Na}^tiona^{l He}^a^{lth L}^a^w^P^r^o^g^r^a^m^{, Na}^tiona^{l L}^a^tina^Ins^titute^f^o^{r Re}^prod^uc^tiv^e^He^a^{lth, a}ⁿ^{d Ib}^{is R}^e^prod^uc^tiv^e
^Heal^t^h^,^“E^m^e^r^g^en^c^y^Coⁿ^t^racep^tⁱ^oⁿ^{& M}^e^dⁱ^cai^d:^A^S^t^at^e-b^y^-S^t^a^t^e^Aⁿ^al^y^sⁱ^s^an^d^A^d^vo^cat^{e’s T}^o^o^l^ki^t^,^{” No}^ve^m^b^{er 2}⁰⁰⁵
^http:^//w^w^w^.ibis^r^e^p^r^o^d^u^c^tiv^e^h^e^a^lth.or^g^/^pub^/^dow^nloa^ds^/^E^C^M^e^d^ic^aⁱ^dA^na^l^y^sⁱ^sT^oolk^it.pdf^.
⁸³^P^a^tr^ic^ia^T^j^a^d^eⁿ^a^{nd N}^a^nc^y^T^hoe^nne^s^,^“^E^x^t^eⁿ^{t, N}^a^t^u^r^e^{, a}ⁿ^{d C}^o^ns^e^que^nc^e^s^of^R^a^pe^Vⁱ^c^tim^iz^a^{tion: F}ⁱ^ndi^ng^s^Fr^om^the
^N^a^tiona^l^Vⁱ^o^l^eⁿ^c^e^A^g^aⁱ^ns^{t W}^o^m^e^{n S}^u^rv^ey^,”^U^.^{S. D}^e^pa^rtm^e^{nt of}^J^u^s^tic^e^,^N^a^tiona^{l I}ⁿ^s^titute^of^J^u^s^tic^e^,^J^a^nua^ry²⁰⁰⁶
^http:^//www^.nc^j^rs.g^ov^/pdf^f^ile^s1^/ⁿⁱ^j/21⁰³⁴⁶^.^p^d^f^.^T^h^e^Na^tiona^{l Crim}^e^Vⁱ^c^tim^iz^a^{tion S}^u^rv^e^y^e^s^ti^m^a^te^{s t}^h^a^t^the^r^e^w^e^re
²⁰⁹^,8⁸⁰^r^a^pe^s^or^s^e^x^u^a^l^a^s^s^a^ultsⁱⁿ²⁰⁰⁴^aⁿ^{d 1}⁹¹^,⁶⁷⁰ⁱⁿ²⁰⁰⁵^{. S}^h^a^nnaⁿ^{M. C}^a^ta^laⁿ^o^{, “}^C^rⁱ^mⁱ^na^{l Vic}^t^im^iza^tion,²⁰^05,”
^{U.S. De}^pa^rtm^e^{nt of}^Justic^e^,^Bure^a^u^of^Justic^e^Sta^tis^tic^{s, Se}^p^t^e^m^be^r²⁰⁰⁶^htt^p^://w^ww^.ojp.usd^oj.g^ov^/^b^js/pu^b^/^pdf^/
^c^v^05.pdf^{. T}^h^e^Uⁿ^if^or^m^C^rⁱ^m^e^R^e^por^ti^ng^P^r^og^r^a^m^,^of^the^U^.^{S. D}^e^p^a^r^t^m^e^{nt of}^J^u^s^tic^e^,^Fe^de^r^a^{l B}^u^r^e^a^u^of^Iⁿ^v^e^s^tig^a^tion,
^st^at^{es i}ⁿ^t^h^{e ann}^u^a^l^re^p^o^r^t^“Cri^m^eⁱⁿ^t^h^{e Un}ⁱ^t^e^d^S^t^at^{es” t}^h^at^t^h^{ere w}^e^{re an}^estⁱ^m^at^ed⁹³^,⁹³⁴^f^o^rci^b^l^e^r^a^p^e^{s rep}^o^r^t^e^d^t^o
^la^w^eⁿ^f^o^rc^e^m^eⁿ^{t in}²⁰⁰⁵^{, a}^1.²^pe^rc^eⁿ^{t de}^c^r^e^a^s^e^c^o^m^p^a^r^e^d^w^{ith 20}⁰⁴^htt^p^://w^ww^.^f^bi.g^ov^/^u^c^r^/^05c^ius/^of^fe^nse^s^/
^vi^o^l^en^t^_^cri^m^e/^f^o^rci^b^l^e^_^r^ap^e.^h^t^m^l^.^Vⁱ^ctⁱ^m^su^rve^y^{s i}ⁿ^dⁱ^cat^{e a l}^a^rgerⁿ^u^m^b^e^{r o}^f^rap^e^{s p}^e^{r y}^e^{ar b}^ecau^se^l^e^{ss t}^h^an⁵⁰
^pe^r^c^eⁿ^{t of}^r^a^pe^s^a^r^e^r^e^por^te^d^{to t}^h^e^polic^e^.
⁸⁴^Fe^lic^ia^{H. Ste}^w^a^r^{t a}^{nd Ja}^m^e^{s T}^r^u^sse^{ll, “}^P^re^v^e^ntioⁿ^of^P^r^e^g^na^nc^y^Re^sulting^f^r^om^Ra^pe^:^A^Ne^g^l^e^c^t^e^d^P^r^e^v^eⁿ^tiv^e
^Heal^t^h^M^easu^r^e,^”^A^m^eri^c^aⁿ^Jou^rⁿ^a^l^o^f^P^r^even^tⁱ^{ve Hea}^l^t^h^Medⁱ^ci^ne^{, v}^.^19,^N^o^v^e^m^b^e^r²⁰⁰⁰^{, p}^p^.²²⁸^-²²^9.

jurisdictional protocols, policies or practices. Released in September 2004, the 141 page ⁸⁵
document, A National Protocol for Sexual Assault Medical Forensic Examination, has been
criticized by numerous organizations because it does not mention offering emergency
contraception to female rape victims.
The DOJ Protocol states on page 111: “Patients of different ages, social, cultural, and
religious/spiritual backgrounds may have varying feelings regarding acceptable treatment options.
Examiners and other involved health care personnel must be careful not to influence patients’
choices of treatment.” The DOJ Protocol recommends that health care providers: discuss the
probability of pregnancy with female patients; conduct a pregnancy test for all patients with
reproductive capability (with their consent); and discuss treatment options with patients. A
footnote directs the reader to the National Sexual Violence Resource Center (877-739-3895 or

717-909-0710 or http://www.nsvrc.org.) for more detailed information about sexual assault and ⁸⁶

pregnancy. An early draft of the document did include mention of emergency contraception. In
contrast to the half page of information on pregnancy, the Protocol offers several pages of
information on treatment of sexually transmitted diseases.
The American College of Obstetricians and Gynecologists and the American Public Health
Association recommend that emergency contraception should be offered to female rape victims ⁸⁷
who are at risk of pregnancy. The American Medical Association, the American Nurses
Association, the American College of Emergency Physicians, the American Academy of
Pediatrics, and the Society for Adolescent Medicine also support advising rape victims about ⁸⁸
emergency contraception and providing the drug when appropriate.
A letter signed by 277 national, state, and local organizations and individuals was sent to the
Department of Justice on January 6, 2005, strongly urging that the Protocol be amended to
include the routine offering of emergency contraception to sexual assault victims who are at risk ⁸⁹
of pregnancy. According to the letter, hospitals often do not provide this service: only 6% of
hospitals in Louisiana, 8% of hospitals in Idaho and 20% of hospitals in Montana provide
emergency contraception on-site to rape victims.
On January 13, 2005, a letter signed by 97 Members of Congress was sent to the Director of the
Office on Violence Against Women expressing concern over the failure to mention emergency ⁹⁰
contraception and urging that the Protocol be changed to include such information.

⁸⁵^T^h^e^{DOJ g}^u^ide^line^s^a^r^e^a^v^a^ila^ble^a^t^ht^t^p^://w^ww^.nc^j^rs.org^/pdf^f^ile^s1/ov^w^/²⁰⁶⁵^54.^pdf^.
⁸⁶^M^a^ri^{e M}^c^Cu^l^l^o^u^g^h^,^G^uⁱ^d^elⁱⁿ^{es f}^o^{r T}^r^eatⁱⁿ^{g Rap}^e^Vⁱ^ctⁱ^m^{s O}^mⁱ^t^E^m^ergen^c^y^Coⁿ^t^racep^tⁱ^oⁿ^,^T^h^e^P^hⁱ^l^ade^l^phi^a
^In^q^u^irer^{, D}^e^c^e^m^b^e^r^31,²⁰^04,^p.^A¹^.
⁸⁷^A^C^O^G^Educ^a^tiona^{l Bu}^lle^tin^{, Se}^x^u^a^l^A^ssa^ult,^Iⁿ^te^r^nat^io^nal^J^our^nal^{of G}^y^ne^c^o^l^ogy^an^{d O}^b^s^t^e^t^rⁱ^c^s^,^{v. 6}⁰^,¹⁹⁹⁸^,^p^p^.
²⁹⁷^-30⁴^;^A^m^eri^c^an^Co^l^l^e^{ge o}^f^Ob^st^et^ri^ci^an^{s an}^{d Gy}ⁿ^eco^l^o^gi^st^s,^Vi^o^l^en^{ce A}^g^aiⁿ^s^t^W^o^m^eⁿ^:^A^c^u^t^{e Care o}^f^S^e^xu^al
^A^s^sa^{ult V}ⁱ^c^tim^{s (200}^4),^a^v^a^ila^ble^a^t^htt^p^://w^ww^.a^c^o^g^.^org^/^de^pa^rtm^e^nts/^de^pt_n^otic^e^.^c^f^m^?^re^c^no=^17&^bulle^tin=¹⁶^{25; a}^nd
^Ameri^can^P^u^b^lⁱ^c^Heal^t^h^A^sso^ci^atⁱ^oⁿ^,²⁰⁰³^P^o^lⁱ^c^y^S^t^at^e^m^en^t^s^,^“2⁰⁰³^-¹⁶^P^r^o^vⁱ^dⁱⁿ^{g A}^{ccess t}^o^E^m^ergeⁿ^c^y^Coⁿ^t^racep^tⁱ^oⁿ
^f^o^{r Surv}^iv^ors^of^Se^x^u^a^l^A^s^s^a^ult,”^a^v^a^ila^ble^a^t^http^://w^w^w^.g^otoe^c^.^org^/^pdf^s^/^Endors^e^m^e^nt_A^P^H^A^_^Se^xua^lA^s^s^a^ult.pdf^.
⁸⁸^Cen^t^{er f}^o^r^P^o^lⁱ^c^y^A^l^t^e^rn^atⁱ^v^e^s^,^“E^m^e^r^g^en^c^y^Coⁿ^t^racep^tⁱ^oⁿ^f^o^{r S}^e^xu^al^A^ssau^l^t^Vⁱ^ctⁱ^m^s,^{” f}^{ound a}^t
^http:^//www^.sta^te^a^c^tion.org^/i^ssu^es/ⁱ^ssu^e.^cfm^/ⁱ^ssu^e/^E^C^-S^exu^a^l^A^s^s^au^l^t^.^xm^l^;^an^d^M^e^l^aⁿⁱ^{e A}^.^G^o^l^d^et^al^.^,^S^o^ci^et^y^f^o^r
^A^d^o^l^escen^t^M^e^dⁱ^ciⁿ^e^,^“^P^r^o^vi^si^oⁿ^o^f^E^m^ergen^c^{y Co}ⁿ^t^racep^tⁱ^oⁿ^t^o^A^d^o^l^escen^t^s^,^”^J^our^nal^of^Ad^ole^s^c^eⁿ^{t H}^e^alth^{, v}^.³⁵^,
^J^u^ly²⁰⁰⁴^pp^{. 6}⁶^-⁷^0.
⁸⁹^T^h^e^le^tte^{r is a}^v^a^ila^ble^onliⁿ^e^a^t^ht^tp://w^ww^.a^c^l^u.org^/^re^pro^duc^tiv^e^rⁱ^g^hts/^g^e^n/127^43re^s²⁰⁰⁵⁰¹⁰^6.^htm^l^.
⁹⁰^T^h^e^le^tte^r^is^a^v^a^ila^ble^a^t^http:^//w^w^w^.^m^a^l^one^y^.^hous^e^.^g^o^v^/^doc^um^eⁿ^ts^/old^doc^s^/^c^hoic^e^/⁰¹¹³^05D^O^J^.^pdf^.

S. 21 (Reid), the Prevention First Act, was introduced on January 4, 2007. The bill would expand
access to preventive health care services that help reduce unintended pregnancy, reduce abortions,
and improve access to women’s health care. It directs the Secretary of Health and Human
Services (HHS) to develop and disseminate information on emergency contraception to the public
and to health care providers. S. 21 would require hospitals, as a condition of receiving federal
funds, to offer and to provide, upon request, emergency contraception to victims of sexual assault.
S. 21 was referred to the Senate Health, Education, Labor, and Pensions Committee. S. 21 is ^th
similar to S. 20 (Reid), which was introduced in the 109 Congress. A companion bill, H.R. 819
(Slaughter), was introduced in the House on February 5, 2007.
H.R. 464 (Rothman), the Compassionate Assistance for Rape Emergencies Act of 2007, was
introduced on January 12, 2007. H.R. 464 is similar to H.R. 2928 (Rothman), which was ^th
introduced in the 109 Congress. The bill would prohibit any federal funds from being provided
to a hospital under Medicare or to a state, with respect to hospital services, under Medicaid,
unless certain conditions are met. A woman who is a victim of sexual assault must be provided
with (1) accurate and unbiased information about emergency contraception, (2) an offer of
emergency contraception, (3) emergency contraception must be provided to the woman upon her
request, and (4) such services cannot be denied because of the inability to pay. H.R. 464 was
referred to the Committee on Energy and Commerce and the Committee on Ways and Means. S.
1240 (Clinton), introduced on April 26, 2007, has the same language and title as H.R. 464, but it
would also provide a woman with risk assessment, counseling, and treatment for certain sexually
transmitted infections. S. 1240 was referred to the Committee on Finance.
H.R. 2064 (Michaud), the Compassionate Care for Servicewomen Act, was introduced on April
26, 2007. The bill would require emergency contraception to be included on the basic core
formulary of the uniform formulary of pharmaceutical agents for the pharmacy benefits program
of the Department of Defense. Under the bill, prior authorization would not be required for
emergency contraception. H.R. 2064 was referred to the Subcommittee on Military Personnel. A
companion bill, S. 1800 (Clinton), was introduced on July 17, 2007. S. 1800 was referred to the
Committee on Armed Services.
H.R. 2503 (DeLauro), the FDA Scientific Fairness for Women Act, was introduced on May 24,
2007. Among other things, the bill would provide for a scientific workshop to review and
evaluate current scientific data on the use of emergency contraceptives by women under the age
of 18. The bill was referred to the House Committee on Energy and Commerce.
H.R. 2596 (Maloney)/S. 1555 (Lautenberg), the Access to Birth Control Act, was introduced on
June 6, 2007. The bill would amend Title II of the Public Health Service Act establishing certain
duties for pharmacies to ensure the provision of an FDA-approved contraceptive, including an
emergency contraceptive, to a customer requesting such a product. The bill would provide a civil
penalty for a violation of up to $5,000 per day, not to exceed $500,000 for all violations
adjudicated in a single proceeding. H.R. 2596 was referred to the House Committee on Energy
and Commerce; S. 1555 was referred to the Committee on Health, Education, Labor, and
Pensions.

The Plan B OTC application was mired in controversy over the three year period from when it
was filed with FDA in April 2003 to its August 2006 approval. Individuals who criticize the
delayed FDA decision believe that Bush Administration policy and FDA actions were based on
political and ideological considerations rather than on sound science. FDA is required by law to
make decisions exclusively on substantial scientific evidence regarding the safety and efficacy of
a drug. These critics believe the FDA decision was delayed to appease conservative religious and
pro-life groups that are long time supporters of President Bush.
President Bush indicated his support for the then-imminent Plan B decision during a news ⁹¹
conference on August 21, 2006. The FDA decision and the President’s support of the decision
have greatly angered conservative religious and pro-life groups. One such organization,
Concerned Women of America, asked that Dr. Andrew von Eschenbach’s nomination as FDA
commissioner be withdrawn and recommended that consumers stop doing business with drug ⁹²
stores that sell OTC Plan B. The Family Research Council, a Christian conservative non-profit
think tank and lobbying organization, states that it is “pursuing legal and legislative options” to ⁹³
overturn the FDA’s decision. Such groups are unhappy because they believe Plan B should only
be used with the supervision of a healthcare professional; they also believe Plan B use may lead
to an increase in unsafe sexual activity.
A recent review of the medical literature, published in April 2007, found that having emergency
contraception on hand “did not lead to increased rates of sexually transmitted infections, ⁹⁴
increased frequency of unprotected intercourse, nor changes in contraceptive methods.” A U.S.
study also found that easier access to emergency contraception did not decrease the use of
condoms or oral contraceptives or lead to an increase in sexually transmitted infections or ⁹⁵
unprotected sex. A followup study found that adolescents younger than 16 years of age behaved
no differently in response to increased access to emergency contraception compared with older ⁹⁶
age groups. Their behaviors did not become riskier: no increased incidence of unprotected sex,
sexually transmitted disease, or pregnancy, nor did they become more vulnerable to unwanted
sexual activity, including the very youngest participants in the study. Moreover, “the adolescents
were equally capable as adults in taking EC correctly, with the youngest adolescents, under 16
years, showing the best results. These results are consistent with findings from [a] previous study
that specifically examined young adolescents ... there was no reason to restrict access in this age
group. The high levels of correct use ... in this study suggest that physician supervision does not

⁹¹^T^h^{e W}^hⁱ^t^e^Ho^u^s^e,^Of^fⁱ^{ce o}^f^t^h^{e P}^r^{ess S}^ecret^ary^,^P^r^{ess Co}ⁿ^f^eren^ce^b^y^t^h^{e P}^r^esi^d^en^t^,^A^u^gu^st²¹^,²⁰⁰⁶
^http:^//w^w^w^.^w^hite^hous^e^.^g^o^v^/^ne^w^s^/r^e^l^e^a^s^e^s^/²⁰⁰^6/^08/²⁰⁰⁶⁰⁸^21.^htm^l^.
⁹²^Dⁱ^e^d^tr^a^H^e^nde^r^s^oⁿ^{, “}^F^D^A^A^ppr^ov^e^s^Sa^le^of^Morⁿ^ing^-^A^f^t^e^r^P^ill^,”^B^o^st^on^Gl^ob^e^{, A}^u^g^u^s^t²⁵^,²⁰^06.
⁹³^J^o^y^c^e^H^o^w^a^r^d^P^r^ic^e^,^“^P^la^{n B}^A^llow^e^{d O}^v^e^r^T^h^e^C^ounte^r^,”^The^W^a^s^hⁱⁿ^gt^on^Tim^e^s^,^A^u^gu^st²⁵^,²⁰⁰⁶^.
⁹⁴^C.^B.^P^o^lⁱ^s^et^al^.^,^“A^d^v^an^{ce P}^r^o^vⁱ^sⁱ^oⁿ^o^f^E^m^er^gen^c^y^Coⁿ^t^racep^tⁱ^o^{n f}^o^{r P}^r^egn^aⁿ^c^y^P^r^even^tⁱ^oⁿ^,^{” Co}^c^h^ran^e^Dat^a^b^a^{se o}^f
^Sy^s^t^em^a^tic^Revⁱ^ew^s^,^A^p^{ril 18,}²⁰^{07, a}^t^htt^p^://w^w^w^.c^oc^hraⁿ^e^.^org^/^re^vⁱ^ew^s^/^eⁿ^/^a^b005⁴⁹^7.h^t^m^l^.
⁹⁵^Tⁱⁿ^a^R.^Raiⁿ^{e et}^al^.^,^“Di^r^ect^A^c^c^e^{ss t}^o^E^m^erg^eⁿ^c^y^C^oⁿ^t^racep^tⁱ^oⁿ^T^h^ro^u^g^h^P^h^arm^aci^{es an}^d^E^f^fect^oⁿ^Unⁱⁿ^t^e^nd^ed
^P^r^e^g^na^nc^y^a^{nd ST}^I^s^,”^J^ourn^a^l^of^the^Ame^r^ic^{an M}^e^dic^a^{l Assoc}ⁱ^a^tioⁿ^,^v.²⁹^3,^Jan^u^a^r^y⁵^,²⁰⁰⁵^,^p^p^.^54-⁶²^.
⁹⁶^Cyⁿ^t^hⁱ^{a Harp}^{er et}^al^.^,^“T^h^e^E^f^f^e^c^t^o^f^In^creased^A^c^{cess t}^o^E^m^ergen^c^y^Coⁿ^t^racep^tⁱ^oⁿ^Am^oⁿ^g^Y^oung^A^dole^s^c^eⁿ^ts^,”
^Ob^st^et^ri^{cs a}ⁿ^d^Gyn^eco^l^o^g^y^{, v}^.¹⁰⁶^{, Se}^p^t^e^m^be^r²⁰⁰⁵^{, p}^p^.⁴⁸^3-⁴⁹¹^.

improve adherence to the regimen and that young adolescents should not be singled out due to ⁹⁷
concerns about their inability to follow the regimen correctly.”
The Society for Adolescent Medicine does not place an age limit on access to emergency ⁹⁸
contraception. The American College of Obstetricians and Gynecologists (ACOG) believes that
Plan B can be safely used without supervision by a physician, and that the age restriction imposed
by FDA is medically unnecessary. In a statement released on the same day as the FDA approval
of OTC status for Plan B, ACOG stated:
^B^y^r^e^strⁱ^c^tin^g^it^{s OT}^{C av}^aila^b^ilit^y^to^w^o^m^eⁿ^ag^{e 1}⁸^an^d^o^l^d^e^r^,^th^{e FD}^A^h^a^s^mⁱ^ssed^aⁿ
^uⁿ^p^aral^l^e^l^e^{d opport}^uⁿⁱ^t^y^t^o^prev^en^t^t^een^a^g^{e pregn}^aⁿ^cⁱ^e^s^.^E^ach^y^{ear t}^h^{ere are}^m^o^{re t}^h^aⁿ
^800,0^{00 t}^een^pregⁿ^aⁿ^cⁱ^e^sⁱⁿ^t^h^{e U}^S^,^wⁱ^t^h^m^a^ny^eⁿ^di^ngⁱⁿ^abortⁱ^oⁿ^.^Pregⁿ^aⁿ^c^yⁱ^t^s^e^l^fⁱ^sⁿ^o^t
^wⁱ^t^h^o^u^{t ris}^k^{, e}^s^peciall^y^f^o^{r a y}^o^un^g^w^o^m^aⁿ^.^T^h^{ere is}ⁿ^o^s^c^ien^tⁱ^f^{ic or}^m^e^{dical reas}^on^to
ⁱ^m^pos^{e a}ⁿ^a^g^{e res}^t^ri^ctⁱ^oⁿ^aⁿ^d^t^o^wⁱ^t^h^h^o^l^d^e^m^erg^eⁿ^c^y^con^t^ra^ceptⁱ^oⁿ^f^r^o^m^t^hⁱ^s^popu^l^a^tⁱ^oⁿ^.⁹⁹
^E^m^erg^eⁿ^c^y^coⁿ^t^raception^is^s^a^f^e^f^o^{r ov}^er-th^e^-^c^oun^{ter us}^{e b}^y^w^o^m^eⁿ^o^f^{all ag}^e^s^.
As stated above, studies of Plan B have shown that women, even young adolescents, can follow
the directions on the package and use the product correctly without an increase in high risk ¹⁰⁰
behaviors. One member of the FDA advisory panel, a pharmacist, noted that for even the
youngest women, the morning-after pill poses less of a health risk than pregnancy: “In terms of
age, I’m not an OB-GYN, but I can’t imagine that I would prefer a ten or 11 year old to be
pregnant over some hypothetical risk that there might be with a ten or 11 year old taking this ¹⁰¹
product. So I guess I would feel pretty strongly about not having any age restrictions.” The side
effects of Plan B would probably influence most women to find another method of regular birth
control. For rape victims who don’t immediately seek medical care, OTC availability would be
expected to be beneficial. Under the FDA approval agreement with Barr, the drug will only be
sold in pharmacies or health clinics where consumers can obtain advice from a pharmacist or
other health care professional. Plan B will not be available at gas stations, convenience stores,
online pharmacies, or other places where other nonprescription drugs are sold.
The primary concern of conservative religious and pro-life groups with Plan B, however, is that it
may prevent the implantation of the embryo in the uterus. Pro-life groups believe that prevention
of embryo implantation in the uterus is an abortion. According to the Catholic pro-life group
Human Life International, “President Bush’s implied support for the abortion-causing drug Plan
B is completely inconsistent with his recent veto of the embryonic stem cell research (ESCR)
funding bill. What the president apparently fails to realize is that Plan B kills the same innocent

⁹⁷^Ibid^.
⁹⁸^M^e^l^aⁿⁱ^{e A}^.^G^o^l^d^et^al^.^,^S^o^ci^et^y^fo^{r A}^d^o^l^escen^t^M^e^dⁱ^ciⁿ^e^,^“^P^ro^vi^si^oⁿ^o^f^E^m^er^gen^c^y^Coⁿ^t^racep^tⁱ^oⁿ^t^o^A^d^o^l^escen^t^s^,^”
^J^ourⁿ^a^{l o}^f^A^dole^s^c^eⁿ^{t H}^e^alt^h^{, v}^.^{35, J}^u^ly²⁰⁰^{4 p}^p^.^66-⁷⁰^.
⁹⁹^{News Rel}^eas^e,^S^t^at^emen^t^o^f^T^h^{e Ameri}^can^Co^l^l^e^{ge o}^f^Ob^st^et^ri^ci^an^{s an}^d^Gyⁿ^eco^l^o^gi^st^s,^On^t^h^{e F}^{DA’s A}^p^p^r^o^v^al^o^f
^O^T^{C Sta}^t^us^f^o^{r P}^l^aⁿ^{B, A}^u^g^u^s^t²⁴^{, 2}⁰⁰⁶^{. A}^v^a^ila^ble^a^t^htt^p^://w^w^w^.^a^c^o^g^.^org^/^f^r^o^m^_hom^e^/^pu^blic^a^tio^ns^/pre^s^s^_^re^le^a^s^e^s^/
^nr⁰⁸^-²^4-⁰⁶^.c^f^m^.
¹⁰⁰^Cy^nthia^{C. H}^a^rpe^r^e^t^a^l^{., “}^T^ole^r^a^b^ility^of^L^e^v^onorg^e^s^t^re^{l Em}^e^r^g^eⁿ^c^y^Contr^acep^tⁱ^oⁿⁱⁿ^A^d^o^l^escen^t^s^,^”^Ameri^can
^J^our^na^l^of^O^b^s^t^e^t^rⁱ^c^s^a^{nd G}^y^ne^c^o^log^y^{, v}^.^191,²⁰^04,^p^p^.¹¹^58-¹¹⁶³^{; R}^a^ine^,^“^D^ir^e^c^t^A^c^ce^s^s^{to Em}^e^r^ge^ncy
^Coⁿ^t^racep^tⁱ^oⁿ^T^h^r^o^u^g^h^P^h^arm^aci^{es an}^d^E^f^f^e^ct^oⁿ^Uniⁿ^t^e^nd^ed^P^r^egn^aⁿ^c^y^an^d^S^T^Is,^”^J^our^nal^of^the^A^m^e^r^ic^{an M}^e^dic^a^l
^Asso^cia^tion^,^v.²⁹³^,^Janu^ary⁵^,²⁰⁰⁵^,^p^p^.⁵⁴^-62^;^Harp^er,^“T^h^e^E^f^f^e^c^t^o^f^In^creased^A^c^{cess t}^o^E^m^ergen^c^y^Coⁿ^t^racep^tⁱ^oⁿ
^A^m^ong^Y^oung^A^dole^s^c^eⁿ^ts^,”^O^b^s^t^e^t^rⁱ^c^s^{and G}^y^ne^c^o^l^ogy^,^v^.¹^06,^Se^pte^m^be^r²⁰⁰⁵^{, p}^p^.⁴⁸^3-⁴⁹¹^.
¹⁰¹^C^o^m^m^eⁿ^t^m^a^de^b^y^D^r^{. J}^u^lie^A^.^J^ohns^on^{, U}ⁿ^iv^e^r^s^ity^of^Flor^ida^C^o^l^l^e^g^e^s^of^P^h^a^r^m^acy^a^{nd Me}^dicⁱ^ne^,^a^t^the
^D^e^c^e^m^b^e^r^{16, 2}⁰⁰³^FD^A^A^d^vⁱ^s^o^r^y^Co^m^m^ittee^Me^e^ting^,^pa^g^e²²⁵^of^a^248-^pa^g^e^traⁿ^s^c^{ript f}^oun^{d a}^t
^http:^//w^w^w^.f^da^.g^ov^/^ohr^m^s^/^doc^k^e^ts^/a^c^/^03/^tr^aⁿ^s^c^rⁱ^pts^/⁴⁰^15T^1.^htm^.

unborn children that the ESCR process does.”¹⁰² The medical community, however, does not
consider prevention of implantation to be an abortion. “Pregnancy begins with implantation, not
fertilization. Medical organizations and the federal government concur on this point. Fertilization
is a necessary but insufficient step toward pregnancy.... Any method of regulation of fertility that ¹⁰³
acts before implantation is not an abortifacient.” FDA does not classify Plan B as an abortion
drug.
Research has found that the use of emergency contraception rises when it is made available
without a prescription. In France, sales of a nonprescription emergency contraceptive, introduced ¹⁰⁴
in 1999, rose 72% over five years. In British Columbia, use of emergency contraception ¹⁰⁵
increased 102% after a new policy allowed pharmacists to dispense without a prescription.
Some experts have estimated that use of emergency contraception in the United States could
prevent 1 million abortions and more than 2 million unintended pregnancies that result in ¹⁰⁶
childbirth each year. However, a report in the January 2007 issue of Obstetrics & Gynecology,
which looked at 23 studies of emergency contraception use, found that “increased access to
emergency contraceptive pills enhances use but has not been shown to reduce unintended ¹⁰⁷
pregnancy rates.” This same conclusion was reached in a separate review of the medical ¹⁰⁸
literature published in April 2007. The authors of this second study found that “advance
provision of emergency contraception did not reduce pregnancy rates when compared to
conventional provision.... The interventions tested thus far have not reduced overall pregnancy ¹⁰⁹
rates in the populations studied.”
Pro-choice groups believe OTC status for Plan B will reduce the number of unintended
pregnancies and reduce the number of abortions performed in the United States. Although pro-
choice groups believe the FDA decision is a step in the right direction, they would have preferred
that OTC status for Plan B would have been approved for all women, not just those 18 and older.
They believe that the age restriction might keep the drug from women who need it the most. An
estimated 3.5 million unwanted pregnancies occur annually, one third of which involve ¹¹⁰
teenagers. In the United States, four in ten girls become pregnant at least once before turning ¹¹¹

20.

¹⁰²^P^r^e^{ss Re}^le^a^s^e^,^Hu^m^a^{n L}ⁱ^f^e^Inte^rna^tio^na^{l, “}^P^re^side^nt^Bush^File^{s f}^o^{r Div}^o^rse^w^{ith Ca}^tholic^Ba^se^,”^Aug^u^{st 2}¹^,²⁰⁰⁶
^http:^//www^.hli.org^/^pre^ss_re^le^a^s^e^s^_div^o^r^cⁱⁿ^g^_^c^a^t^holic^_ba^s^e^.htm^l.
¹⁰³^Davⁱ^d^A^.^G^rⁱ^m^{es, “E}^merg^en^c^y^C^oⁿ^t^racep^ti^oⁿ^—^Ex^p^aⁿ^dⁱⁿ^g^Op^p^o^rt^uⁿ^{ities f}^o^r^P^r^im^ar^y^P^r^ev^en^tioⁿ^,^”^T^h^{e New}
^Engl^an^{d J}^o^urⁿ^a^{l O}^f^M^e^dicⁱ^ne^,^v^.³³⁷^{, O}^c^to^be^r^9,¹⁹⁹⁷^,^pp.¹⁰⁷⁸^-¹⁰⁷⁹^.
¹⁰⁴^Barb^{ara M}^a^rtⁱⁿ^{ez an}^{d A}ⁿⁿ^a^Wⁱ^l^d^{e M}^a^t^h^ew^s,^“E^asi^e^r^A^c^{cess t}^o^Coⁿ^t^racep^tⁱ^v^{es M}^a^y^Bo^o^s^t^Co^st^s,^”^T^h^{e Wa}^l^l^S^t^reet
^J^ourⁿ^a^l^{, A}^u^g^u^s^t²⁵^,²⁰^06,^p.^A⁸^.
¹⁰⁵^Ibid^.
¹⁰⁶^Ja^m^e^s^T^r^u^{ssell et al., “Em}^e^r^g^en^c^y^Coⁿ^t^racep^tiv^{e P}^{ills: A}^Sim^p^{le Pro}^p^o^s^{al to}^Re^d^u^{ce Un}ⁱⁿ^ten^d^ed^P^r^egⁿ^eⁿ^c^ies,”
^Family^Pl^anⁿⁱⁿ^g^Pe^rspe^c^tiv^e^s^{, v}^.^{24, N}^o^v^e^m^b^e^r^-^D^e^c^e^m^b^e^r^1992,^p^p^{. 2}⁶⁹^-²^73.
¹⁰⁷^Eliz^a^b^e^t^{h G}^.^R^a^y^m^{ond, e}^t^a^l^{., “}^P^opu^la^tio^{n Ef}^f^e^c^t^of^Iⁿ^c^r^ea^s^e^{d A}^c^ce^s^s^{to Em}^e^r^ge^ncy^C^ontr^acep^tⁱ^v^{e P}ⁱ^l^l^s^—A
^S^y^s^t^em^a^tⁱ^c^R^e^vⁱ^ew^,^”^O^b^s^t^e^t^rⁱ^c^s^{and G}^y^ne^c^o^l^ogy^,^v^.¹^09,^J^a^nua^r^y²⁰⁰⁷^{, p}^p^.¹⁸^1-¹⁸⁸^.
¹⁰⁸^C.^B.^P^o^lⁱ^s^et^al^.^,^“A^d^v^an^{ce P}^r^o^vⁱ^sⁱ^oⁿ^o^f^E^m^er^gen^c^y^Coⁿ^t^racep^tⁱ^o^{n f}^o^{r P}^r^egn^aⁿ^c^y^P^r^even^tⁱ^oⁿ^,^{” Co}^c^h^ran^e^Dat^a^b^a^se
^of^Sy^ste^m^a^tic^Re^vⁱ^e^w^s,^A^p^{ril 18,}²⁰⁰^{7, a}^t^htt^p^://w^ww^.c^oc^hraⁿ^e^.^org^/^re^vⁱ^e^w^s/^eⁿ^/a^b0⁰⁵⁴⁹^7.h^t^m^l^.
¹⁰⁹^Ibid^.
¹¹⁰^Cen^t^{ers f}^o^{r Di}^{sease Co}ⁿ^t^ro^l^and^P^r^even^tⁱ^oⁿ^,^“Natⁱ^oⁿ^a^l^and^S^t^at^e-S^p^eci^fⁱ^{c P}^r^egn^aⁿ^c^y^Rat^e^s^Am^oⁿ^g^S^t^at^es,¹⁹⁹⁵^-
¹⁹⁹^7,”^{MMWR Mo}^rb^id^ity^aⁿ^d^Morta^{lity Weekly Rep}^o^r^t^,^v.⁴⁹^,²⁰^00,^p^p^.⁶⁰^5-⁶¹¹^.
¹¹¹^N^a^tiona^{l C}^a^m^p^aⁱ^gⁿ^to^P^r^e^v^eⁿ^{t T}^e^eⁿ^P^r^e^g^na^nc^y^,^N^o^{t J}^u^s^t^A^not^he^r^Sing^le^I^s^s^u^e^:^T^e^eⁿ^P^r^e^g^na^nc^y^P^r^e^v^eⁿ^tion’^s^Lⁱ^nk
^{to O}^t^he^r^C^r^itic^a^l^Socⁱ^a^l^I^s^s^u^e^s^{, Fe}^br^ua^r^y²⁰⁰²^{. A}^v^a^ila^ble^a^t^http:/^/w^w^w^.tee^npr^e^g^na^nc^y^.^or^g^/^r^e^s^our^c^e^s^/da^t^a^/^pdf^/
^notj^u^s^t^.^pdf^.

Prescriptions of Plan B have been covered by most state Medicaid programs and many private ¹¹²
health insurers. Drugs that are switched to OTC typically lose insurance coverage and therefore
the OTC switch for Plan B may result in increased cost to insured consumers who buy the drug
without a prescription. Prior to the change to OTC status, Plan B was prescribed about 1.5 million
times per year in the United States; about half are filled in clinics such as Planned Parenthood or ¹¹³
on college campuses. During its first month as an OTC drug, Plan B was available in in one
state, Pennsylvania for $20 through Planned Parenthood clinics and for $39.99 to $44.99 at ¹¹⁴
various retail pharmacies. According to Barr Pharmaceuticals, sales of Plan B in the United
States have doubled since August 2006, “rising from about $40 million a year to what will ¹¹⁵
probably be close to $80 million for 2007.”
^Ju^di^t^h^A^.^Johⁿ^s^oⁿ ^Van^e^s^s^{a K. B}^u^rro^w^s
^Specialis^{t i}ⁿ^Bⁱ^o^m^{edical P}^o^licy^L^e^gⁱ^s^l^at^iv^{e A}^t^torn^e^y
^j^a^j^o^hnsoⁿ^@^c^r^s.^l^o^c^.^go^v^{, 7}^-⁷⁰⁷⁷^v^b^u^r^ro^w^s^@^c^rs^.l^oc.g^ov^{, 7-}⁰⁸³¹

¹¹²^Barb^{ara M}^a^rtⁱⁿ^{ez an}^{d A}ⁿⁿ^a^Wⁱ^l^d^{e M}^a^t^h^ew^s,^“E^asi^e^r^A^c^{cess t}^o^Coⁿ^t^racep^tⁱ^v^{es M}^a^y^Bo^o^s^t^Co^st^s,^T^h^{e Wa}^l^l^S^t^reet
^J^ourⁿ^a^l^{, A}^u^g^u^s^t²⁵^,²⁰^06,^p.^A⁸^.
¹¹³^Ibid^.
¹¹⁴^{Jill Da}^ly^{, “}^O^T^C^P^l^aⁿ^B^Ma^rk^{s Fi}^{rst Mo}^nth,”^Pittsb^u^rg^{h P}^o^st-Gaze^tte^{, D}^e^c^e^m^b^e^r^13,²⁰^06,^p.^F1^.
¹¹⁵^R^ob^Steⁱⁿ^,^“^P^la^{n B}^U^s^e^Sur^g^e^s^,^A^{nd So D}^o^e^s^C^ontr^o^v^e^r^s^y^,^”^T^h^{e Wa}^shⁱⁿ^gt^on^Po^st^{, J}^u^ly^{13, 2}⁰⁰⁷^,^{p. A}¹^.