October 24, 2005

Food and Drug Administration, HHS

Division of Dockets Management

5630 Fishers Lane, Rm. 1061

Rockville, MD 20852

**RE: RIN 0910-AF72**

**Docket No. 2005N-0345**

To Whom It May Concern:

The Education Fund of Family Planning Advocates of New York State and
the Clara Bell Duvall Reproductive Freedom Project of the ACLU of
Pennsylvania are committed to ensuring that all women have access to
reproductive health services, including medications to prevent an
unintended pregnancy. We are particularly concerned with rape victims'
access to such services and therefore strongly encourage the Federal
Food and Drug Administration to make emergency contraception available
over-the-counter to women of all ages.

In response to the questions posed in RIN 0910-AF72, the under signers
believe the first three questions (1A, 1B and 1C) should be answered in
the negative, making it unnecessary to address the remaining questions.
We do not believe there is any confusion over the interpretation of
section 503 of the Federal Food, Drug and Cosmetic Act. We feel it is
clear that the delays in approving the application to classify Plan B as
an over-the-counter medication, and request for information these
comments address, are the result of inappropriate political interference
as opposed to "significant confusion" over section 503's interpretation.
The questions over how to label, market and enforce an age-restricted
medication are the end result of a process that has allowed politics and
ideology to interfere with decisions that should be based on medical
fact and reason.

**EC access for rape victims**

A study published in the American Journal of Preventive Medicine
estimated that of the more than 25,000 rape related pregnancies
nationwide each year, 22,000 could be prevented through timely use of
emergency contraception.[^1] But women who are assaulted face a unique
set of barriers in obtaining the medication.

Following an assault, some victims of sexual assault seek care in
emergency departments and receive emergency contraception. However,
various studies indicate that hospital policies vary widely within
states and across the country. In a recent overview of state surveys
eight of the eleven states studied, fewer than 40 percent of facilities
dispense EC on-site to sexual assault patients, underscoring the need to
grant over-the-counter status to emergency contraception.[^2]

While some women seek treatment in hospital emergency departments, the
preponderance of evidence is that most women who have been assaulted do
not present at hospitals for care. They may be too traumatized, too
afraid, or ashamed to seek services at a hospital. According to a
longitudinal study by the National Institute on Drug Abuse, NIH/HHS, 84%
of women did not report a forcible rape to the police;[^3] and only 18%
of women who do not report a rape or sexual assault to the police
receive medical treatment.[^4] While victims who receive care at a
hospital are more likely to have better outcomes following the assault,
the simple reality is that most women do not seek this care. Allowing
emergency contraception to become an over-the-counter product would
allow a woman, family member or friend to obtain the medication thereby
greatly reducing the chance she will face the addition trauma of a
pregnancy as a result of the assault.

**Evidence shows EC is suitable for OTC use**

The FDA has received substantial documentation that offers clear and
convincing evidence that EC is a safe and effective drug suitable for
self-medication.

Overwhelming evidence shows that EC is a safe and effective medication
whose benefits are best realized by removing unnecessary barriers to
access. This evidence has caused the American Medical Association and
the American College of Obstetricians and Gynecologists to support
making EC an over-the-counter medication. This support would not have
been forthcoming if there were valid evidence showing it would be
inadvisable or dangerous to public health if EC could be obtained
without a doctor's prescription.

**EC Benefits**

Unintended pregnancy is a public health issue that has long-ranging
health impacts and for victims of sexual assault an unintended pregnancy
can have devastating consequences. Women with unintended pregnancy
forego the opportunity to receive pre-conception counseling to improve
the health of the fetus and are more likely to have low birth weight
babies and experience a higher rate of neonatal mortality.[^5]

Making EC available over-the-counter would enable women to obtain the
medication in a timely manner. EC is a time-sensitive medication that is
most effective the sooner it is taken after unprotected or coerced
intercourse. Making the medication available over-the-counter will
enhance women's ability to prevent unintended pregnancy by allowing them
to obtain the medication when it has the greatest potential for
effectiveness.

**Conclusion**

In the interest of providing compassionate care to victims of sexual
assault, we strongly believe that the pending application to allow Plan
B to be over-the-counter should be approved without any age
restrictions.

Sincerely,

JoAnn M. Smith Carol Petraitis

President & CEO Director

The Education Fund of Clara Bell Duvall Reproductive

Family Planning Advocates of NYS Freedom Project of the ACLU of PA

[^1]: Stewart, F. and Trussell, J. "Prevention of Pregnancy Resulting
    from Rape," *American Journal of* *Preventive Medicine*. 2000
    (19):228-229.

[^2]: ACLU Reproductive Freedom Project Briefing Paper, *Preventing
    Pregnancy after Rape: Emergency Care Facilities Put Women at* Risk
    (2004), *available at*
    http://www.aclu.org/Files/OpenFile.cfm?id=17211.

[^3]: Kilpatrick, DG. Risk factors for substance abuse: a longitudinal
    study. Bethesda (MD): National Institute on Drug Abuse. Grant
    No.:1R01-DA05220. 4/1/1989-3/31/1993.

[^4]: Rennison, Callie Marie, PhD. Bureau of Justice Statistics. Rape
    and Sexual Assault: Reporting to Police and Medical Attention,
    1992-2000. August 2002.
    <http://www.ojp.usdoj.gov/bjs/pub/pdf/rsarp00.pdf>

[^5]: R. Bonoan and J. Gonen, "Promoting Healthy Pregnancies: Counseling
    and Contraception as the First Step," Washington Business Group on
    Health, August 2000.