COMMENTS ON THE APPLICATION TO SWITCH PLAN B^®^ FROM PRESCRIPTION-ONLY
TO OVER-THE-COUNTER STATUS

Joint Public Meeting of the FDA Advisory Committees on Reproductive
Health and Non-Prescription Drugs

**December 16, 2003**

**INTRODUCTION**

NARAL Pro-Choice America and our co-signers[^1] respectfully submit
these comments in support of the application to switch the emergency
contraceptive Plan B® from prescription-only to over-the-counter status.
NARAL Pro-Choice America is a 501(c)(4) national grassroots advocacy
organization with hundreds of thousands of members and a state affiliate
network. NARAL Pro-Choice America is committed to ensuring women's
access to the full range of reproductive health options, including
preventing unintended pregnancy, bearing healthy children, choosing
adoption, and choosing legal abortion. We believe that increasing access
to emergency contraception (EC) is one of the most promising avenues for
reducing unintended pregnancy and the need for abortion, and we argue
that Plan B^®^, an emergency contraceptive pill (ECP) containing the
progestin levonorgestrel, should be made available over-the-counter.

**I. IMPROVED ACCESS TO EMERGENCY CONTRACEPTION IS CRITICAL TO REDUCING
UNINTENDED PREGNANCIES AND IMPROVING WOMEN'S HEALTH**

ECPs are a concentrated dosage of ordinary birth control pills that
dramatically reduce a woman's chance of becoming pregnant. In fact, Plan
B^®^ can reduce a woman's chance of becoming pregnant by up to 89
percent if taken within days of unprotected sex.[^2] ECPs do not cause
abortion; rather they *prevent* pregnancy by inhibiting ovulation,
fertilization, or implantation before a pregnancy occurs.[^3] EC has a
tremendous potential to reduce the number of unintended pregnancies and
the need for abortion. Approximately three million unintended
pregnancies occur annually in the United

States.[^4] More than half of these unintended pregnancies happen to
women using a regular contraceptive method during the month that they
became pregnant.[^5] Increased use of ECPs could reduce unintended
pregnancies by half, thereby greatly reducing the need for abortion.[^6]
In fact, a 2002 study by the Alan Guttmacher Institute revealed that ECP
use was likely responsible for up to 43 percent of the decline in the
abortion rate between 1994 and 2000 -- with ECP use preventing over
50,000 abortions in 2000 alone.[^7]

Unfortunately, lack of access to emergency contraception may contribute
to higher rates of unplanned pregnancy in the U.S. compared to countries
where emergency contraception is widely available.[^8] Negative health
outcomes -- including delayed or inadequate prenatal care, increased
likelihood of low birth weight and death in the first year of life,
increased risk of the mother being physically abused, and economic
hardship -- are strongly associated with unintended pregnancy.[^9] By
increasing women's contraceptive options, EC gives women greater control
over their reproductive lives and thereby improves the health and
well-being of women and their families.

Despite EC's tremendous potential in reducing unintended pregnancies and
the need for abortion, numerous barriers to access still exist.
Significantly, EC can be difficult to obtain in a timely manner because
women must obtain a prescription to use it. [^10] First, many women lack
a regular health care provider. Second, timely access to a provider can
be difficult. For example, if a couple is faced with a broken condom on
a Friday night, and the woman's doctor's office is closed over the
weekend, she might have to wait until the following Monday -- three days
later -- to obtain a prescription for EC. Women in rural areas may have
to travel great distances to reach the nearest doctor or clinic, making
a prescription within the relevant time frame after unprotected sex
difficult, even impossible, to obtain. Even under less extreme
circumstances, obtaining a prescription for EC can be problematic. A
2000 study of the Emergency Contraception Hotline (1-888-NOT-2-LATE), a
24-hour, automated phone line that provides the names and telephone
numbers of clinicians who prescribe EC in the caller's geographic area,
found that even when calls to clinicians were made during business hours
about one in four calls did not result in an appointment or a telephone
prescription from a hotline health care professional within 72
hours.[^11] Because ECPs are more effective the sooner they are
used,[^12] the obstacles associated with obtaining a prescription for
ECPs pose a serious threat to women's health.

Additionally, making EC available over-the-counter would greatly assist
sexual assault victims. Each year, approximately 25,000 women in the
United States become pregnant as a result of rape.[^13] An estimated
22,000 of these pregnancies --- or 88 percent --- could be prevented if
sexual assault victims had timely access to emergency
contraception.[^14] Hospitals could help alleviate some of the trauma
associated with sexual assault by providing sexual assault victims with
EC. Unfortunately, however, too few hospitals treat this as the standard
of care.[^15] In fact, a nationwide study found that fewer than half of
all rape survivors eligible for emergency contraception actually
received the treatment during a visit to a hospital emergency room.[^16]

For all of these reasons, switching EC to over-the-counter status is
critical to eliminating barriers to use and in improving women's health.

**II. PLAN B® MEETS FDA CRITERIA FOR OVER-THE-COUNTER DRUGS**

Because Plan B^®^ is safe, effective, and easily administered, it is
suitable for non-prescription (i.e., over-the-counter) availability.
Making Plan B^®^ available over-the-counter would eliminate an
unnecessary barrier to women's access to this important contraceptive
option.

**A. FDA CRITERIA FOR OVER-THE-COUNTER DRUGS**

To be approved by the FDA for over-the-counter distribution, a drug must
meet certain criteria:

-   the drug must be safe and effective;

-   taking the drug must be safe enough that medical supervision -- and
    thus, a prescription -- is not necessary to preserve public health
    due to the drug's toxicity, its potential for harmful side-effects,
    or its method of use;

-   the drug must be simple enough to use that instructions on the
    drug's packaging are sufficient to ensure safe and correct
    self-medication.[^17]

The FDA requires a prescription for drugs that, because of their
toxicity, their potential for harmful side-effects, or their method of
use, are not safe to use except under the supervision of a medical
professional.[^18]

Plan B^®^ meets the criteria for non-prescription status and can be
safely marketed over-the-counter.

# ECPs ARE SAFE AND EFFECTIVE

-   Oral contraceptives, the same drugs found in ECPs, have been studied
    for over three decades. They have been studied more extensively and
    have been found to be safer than most drugs in medicine. No serious
    medical consequences from an overdose of oral contraceptives have
    been reported.[^19]

-   Plan B^®^ can reduce a woman's chance of becoming pregnant by up to
    89 percent if taken within days of unprotected sex.[^20]

# 

# ECPs HAVE MINIMAL SHORT-TERM SIDE-EFFECTS

-   The most common side-effects of ECPs are nausea and vomiting; other
    side-effects include dizziness, fatigue, and headache. These
    short-term side-effects are not serious and are easily manageable
    without medical supervision.[^21] Moreover, Plan B®, as a
    progestin-only drug, reduces the incidence of nausea by 50 percent
    and vomiting by 75 percent, as compared to ECPs containing both
    estrogen and progestin.[^22]

-   Long-term side-effects are unlikely given the very short duration of
    treatment.[^23]

-   Use of ECPs is less dangerous than pregnancy.[^24]

# ECPs ARE EASY AND SAFE TO SELF-ADMINISTER

-   In a study of Scottish women who were given an advance supply of
    ECPs to keep at home, 98 percent of the women who used ECPs used
    them correctly, and none experienced serious adverse effects.[^25]

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-   Women can diagnose their own need for ECPs; taking the drug involves
    simply swallowing pills.[^26]

-   The dosage and timing of ECP use are the same regardless of the
    individual characteristics of the woman.[^27]

-   No specific medical conditions preclude a woman's use of ECPs. In
    fact, the only contraindication to ECPs is pregnancy -- not because
    ECPs can harm a pregnant woman or a developing embryo, but because
    ECPs will not work once pregnancy begins.[^28]

**NON-PRESCRIPTION ACCESS TO EC DOES NOT DISCOURAGE ONGOING
CONTRACEPTIVE USE**

-   Claims that increased access to emergency contraception might
    encourage riskier sexual behavior or lead to less frequent use of
    other forms of contraception have not been supported by recent data.
    A Scotland study found that, compared to women who had to go through
    their doctors to obtain EC, women who had a supply of ECPs available
    at home did not differ in their use of other forms of contraception
    and were not more likely to use EC more frequently. In addition, 98
    percent of the women reported that they did not take more risks as a
    result of having EC readily available.[^29]

# LEADING MEDICAL GROUPS SUPPORT OVER-THE-COUNTER ACCESS TO ECPs

-   The American Medical Association (AMA) supports increased access to
    ECPs. And, the AMA's Council on Medical Service has stated,
    over-the-counter access to ECPs is especially critical for "the
    large number of women who have limited access to health care
    services, who are uninsured, and who have no established
    relationship with a physician. For these women, having emergency
    contraception available over-the-counter may be the most appropriate
    way for them to have adequate access to the pills."[^30]

-   In February 2001, more than 70 organizations, including the American
    Nurses Association, the American Academy of Pediatrics, the American
    Public Health Association, and the Association of Reproductive
    Health Professionals, filed a citizen's petition to request that the
    FDA switch certain emergency contraceptive pill products from
    prescription to over-the-counter status, arguing that "limiting EC
    to prescription dispensing is not necessary for the protection of
    public health."[^31]

**CONCLUSION**

In short, ECPs have all of the characteristics of an over-the-counter
drug: emergency contraception pills are safe, effective, and simple to
use; they are not associated with any serious or harmful side-effects;
they are not dangerous to women with particular medical conditions; and
their use does not lead to riskier behavior or less frequent use of
other forms of contraception. EC has enormous potential to reduce
unintended pregnancy and the need for abortion. In fact, wider access to
and use of EC is one of the most promising avenues for reducing this
country's high rate of unintended pregnancy. If women saw ECPs in
pharmacies, awareness of ECPs would increase tremendously. This could
make a crucial difference to millions of women. However, without speedy
and uncomplicated access to EC, women cannot take full advantage of this
important contraceptive option. Making ECPs available over-the-counter
would remove this barrier to access and help to improve women's health.
NARAL Pro-Choice America and our co-signers therefore urge the FDA to
approve the application to switch Plan B® from prescription-only to
over-the-counter status.

Respectfully Submitted,

Kate Michelman

President

NARAL Pro-Choice America

**Notes:**

[^1]: ^^ NARAL Pro-Choice California, NARAL Pro-Choice Colorado, NARAL
    Pro-Choice Connecticut, NARAL Pro-Choice Georgia, NARAL Pro-Choice
    Maryland, NARAL Pro-Choice Massachusetts, MARAL Pro-Choice Michigan,
    NARAL Pro-Choice Minnesota, Missouri NARAL, NARAL Pro-Choice
    Montana, NARAL of New Hampshire, NARAL Pro-Choice New Mexico, NARAL
    Pro-Choice New York, NARAL Pro-Choice Ohio, NARAL Pro-Choice Oregon,
    NARAL Pennsylvania, NARAL Pro-Choice South Dakota, TARAL, NARAL
    Pro-Choice Virginia, NARAL Pro-Choice Washington, NARAL Pro-Choice
    Wisconsin, and Wyoming NARAL.

[^2]: Press Release, Women's Capital Corporation, A New Generation of
    Emergency Contraception Has Arrived (July 28, 1999) (on file with
    NARAL Pro-Choice America). While labels for FDA-approved ECPs
    indicate that they should be used within 72 hours after unprotected
    sex, recent research shows that emergency contraceptive pills can be
    effective up to 120 hours after sex. However, ECPs are more
    effective the sooner they are taken. Helena von Hertzen et al., *Low
    Dose Mifepristone and Two Regimens of Levonorgestrel for Emergency
    Contraception: a WHO Multicentre Randomized Trial*, 360
    [The]{.smallcaps} [Lancet 1803,]{.smallcaps} 1803-10 (2002);
    Charlotte Ellertson et al., *Extending the Time Limit for Starting
    the Yuzpe Regimen of Emergency Contraception to 120 Hours,* 101
    [Obstetrics & Gynecology]{.smallcaps} 1168, 1168-71 (2003); Gilda
    Piaggio et al., *Timing of Emergency Contraception with
    Levonorgestrel or the Yuzpe Regimen* 353 [The Lancet]{.smallcaps}
    721 (1999).

[^3]: [Robert A. Hatcher et al.,]{.smallcaps} [Emergency Contraception:
    The Nation's Best Kept Secret]{.smallcaps} 29-30 (1995); American
    College of Obstetricians & Gynecologists (ACOG), Statement on
    Contraceptive Methods (July 1998).

[^4]: Stanley Henshaw, *Unintended Pregnancy in the United States,* 30
    [Family Planning Perspectives 24, 26]{.smallcaps} (1998).

[^5]: *Id.* at 26-27.

[^6]: Based on data from the 1980s, it is estimated that increased use
    of ECPs could reduce the number of unintended pregnancies by 1.7
    million annually. James Trussell et al., *Emergency Contraceptive
    Pills: A Simple Proposal to Reduce Unintended Pregnancies*, 24
    [Family Planning Perspectives]{.smallcaps} 269, 270 (1992).

[^7]: Rachel K. Jones et al., *Contraceptive Use Among U.S. Women Having
    Abortions in 2000-2001*, 34 [Perspectives on Sexual and Reproductive
    Health]{.smallcaps} 294, 300 (2002).

[^8]: Richard A. Grossman & Bryan D. Grossman, *How Frequently Is
    Emergency Contraception Prescribed?*, 26 [Family Planning
    Perspectives]{.smallcaps} 270, 270 (1994).

[^9]: [Committee on Unintended Pregnancy, Institute of Medicine, The
    Best Intentions]{.smallcaps} 81 (Sarah S. Brown & Leon Eisenberg
    eds., 1995).

[^10]: Only five states -- Alaska, California, Hawaii, New Mexico, and
    Washington -- currently allow pharmacists to dispense EC without a
    doctor's prescription. Alan Guttmacher Institute, State Policies in
    Brief: Access to Emergency Contraception (Dec. 1, 2003).

[^11]: Approximately 75 percent of the calls resulted in an appointment
    or a telephone prescription from a hotline provider; 14 percent were
    deemed failures; and 11 percent resulted in referrals to other
    providers. James Trussell et al., *Access to Emergency
    Contraception*, 95 [Obstetrics & Gynecology]{.smallcaps} 267, 267-70
    (2000).

[^12]: Gilda Piaggio et al., *Timing of Emergency Contraception with
    Levonorgestrel or the Yuzpe Regimen*, 353 [The Lancet]{.smallcaps}
    721 (1999)[.]{.smallcaps}

[^13]: Felicia Stewart & James Trussell, *Prevention of Pregnancy
    Resulting from Rape: A Neglected Preventive Health Measure*, 19
    [American Journal of Preventive Medicine 228, 228
    (2000).]{.smallcaps}

[^14]: *Id.* at [229.]{.smallcaps}

[^15]: Only four states -- California, New Mexico, New York, and
    Washington -- have laws explicitly requiring hospitals to provide
    rape survivors with information about and access to EC. [Cal. Penal
    Code]{.smallcaps} § 13823.11; [N.M. Stat. Ann]{.smallcaps}. §
    24-10D-3; N[.Y. Public Health Law]{.smallcaps} § 2805-p (effective
    Jan. 28, 2004); [Wash. Rev. Code Ann]{.smallcaps}. § 70.41.350.

[^16]: Annette Amey & David Bishai, *Measuring the Quality of Medical
    Care for Women Who Experience Sexual Assault with Data from the
    National Hospital Ambulatory Medical Care Survey*, 39 [Annals of
    Emergency Medicine]{.smallcaps} 631, 636 (2002).

[^17]: 21 C.F.R. § 310.200(b).

[^18]: 21 U.S.C.A. § 353(b)(1)(A).

[^19]: ^?^ Maureen B. Gardner, Office of Research Reporting, National
    Institute of Child Health and Human Development (NICHD), "Facts
    About Oral Contraceptives," June 1983 (fact sheet), reprinted by the
    National Institutes of Health
    \<http://www.nih.gov/health/chip/nichd/oralcnt/\> (6/13/00);
    Charlotte Ellertson et al., *Should Emergency Contraceptive Pills Be
    Available Without Prescription?*, 53 JAMWA 226, 227 (1998).

[^20]: Press Release, Women's Capital Corporation, A New Generation of
    Emergency Contraception Has Arrived (July 28, 1999) (on file with
    NARAL Pro-Choice America); *see also supra* note 1.

[^21]: Task Force on Postovulatory Methods of Fertility Regulation,
    *Randomised Controlled Trial of Levonorgestrel Versus the Yuzpe
    Regimen of Combined Oral Contraceptives for Emergency
    Contraception,* 352 [The Lancet]{.smallcaps} 428, 431 (1998);
    Charlotte Ellertson et al., *Should Emergency Contraceptive Pills Be
    Available Without Prescription?*, 53 JAMWA 226, 228 (1998).

[^22]: Press Release, Women's Capital Corporation, A New Generation of
    Emergency Contraception Has Arrived (July 28, 1999) (on file with
    NARAL Pro-Choice America); Task Force on Postovulatory Methods of
    Fertility Regulation, *Randomised Controlled Trial of Levonorgestrel
    Versus the Yuzpe Regimen of Combined Oral Contraceptives for
    Emergency Contraception*, 352 [The Lancet]{.smallcaps} 428, 431
    (1998).

[^23]: Charlotte Ellertson et al., *Should Emergency Contraceptive Pills
    Be Available Without Prescription?*, 53 JAMWA 226, 227-28 (1998).

[^24]: Anna Glasier, *Safety of Emergency Contraception*, 53 JAMWA 219,
    219 (1998).

[^25]: Anna Glasier & David Baird, *The Effects of Self-Administering
    Emergency Contraception,* 339 [New England Journal of
    Medicine]{.smallcaps} 1, 1-4 (1998).

[^26]: Charlotte Ellertson et al., *Should Emergency Contraceptive Pills
    Be Available Without Prescription?,* 53 [JAMWA 226, 227
    (1998).]{.smallcaps}

[^27]: *Id.*

[^28]: *Id.*

[^29]: Anna Glasier & David Baird, *The Effects of Self-Administering
    Emergency Contraception,* 339 [New England Journal of
    Medicine]{.smallcaps} 1, 3-4 (1998).

[^30]: Press Release, American Medical Association (AMA), AMA on Access
    to Emergency Contraception, Dec. 5, 2000,
    http://www.ama-assn.org/ama/pub/article/1617-3547.html; AMA Council
    on Medical Service, "Access to Emergency Contraception," CMS Report
    1-I-00 (2000), 6.

[^31]: Center for Reproductive Law & Policy, Citizen's Petition to the
    U.S. Food and Drug Administration on behalf of the American Nurses
    Association, the American Academy of Pediatrics, the American Public
    Health Association, the Association of Reproductive Health
    Professionals et al., Feb. 14, 2001.