President George W. Bush
The White House

Re:  Petition to Sell Emergency Contraceptive ""Plan B"" Over-the-Counter, 

No. 2001P-0075

Dear President Bush:

As you know, the Food and Drug Administration (""FDA"") is considering a petition by the manufacturer of the emergency contraceptive ""Plan B,"" to allow
Plan B to be sold over-the-counter, without a doctor's prescription.  We urge you to support this petition, which will help to prevent unintended pregnancies,
reduce abortions, and promote women's reproductive health and rights.

Two FDA Advisory Committees Have Voted to Support this Petition.

In December, two FDA advisory committees of medical experts voted overwhelmingly (23-4) in favor of granting this petition.   In reaching this conclusion, the
joint advisory panel considered extensive scientific and social science evidence indicating that the drug is safe and effective and that it would serve the public health.  The panel also considered a study that showed that easy access to emergency contraception does not cause adolescents to have more unprotected
sex or to stop using contraception.  See Melanie Gold, Testimony at the Meeting of the FDA Nonprescription Drugs Advisory Committee in Joint Session with
the Advisory Committee for Reproductive Health Drugs 155-57 (Dec. 16, 2003), available at www.fda.gov/ohrms/dockets/ac/03/transcripts/4015T1.pdf.  Indeed,
the FDA panel unanimously agreed both that Plan B was safe for use in a non-prescription setting and that there was no evidence that over-the-counter availability leads people to substitute emergency contraception for regular use of other contraceptive methods.  Id. at 354-64.  Given the conclusions of this expert panel,
the petition should be granted.  Over-the-counter availability is the only way to ensure true access to emergency contraception for the many women who need it. 

Over-the Counter Availability Will Ensure Access to Emergency Contraception.

Nearly half of all pregnancies in the United States are unintended.  See Stanley K. Henshaw, Unintended Pregnancy in the United States, 30 Fam. Plan. Persp.
24, 26 (1998).  For the women who face a potential unintended pregnancy, widespread and timely access to emergency contraception is critical.  

Emergency contraception must be taken within 72 to 120 hours after unprotected intercourse, but most experts agree that it is more effective the sooner it
is taken.  See Charlotte Ellertson et al., Extending the Time Limit for Starting the Yuzpe Regimen of Emergency Contraception to 120 Hours, 101 Obstet.
Gynecol. 1168, 1168 (2003).  This narrow window makes ready access to emergency contraception critical.  The current requirement that emergency
contraception only be dispensed with a doctor's prescription acts as significant barrier to obtaining this safe and effective method of birth control.  For women
who cannot afford a doctor's appointment, whose doctor's office is closed during the critical period, who cannot obtain an appointment within the short window,
or whose pharmacist does not stock emergency contraception, the prescription requirement serves as a major impediment to obtaining the drug within the
necessary time frame. 

Denied access to emergency contraception, some women will face a choice of either continuing an unwanted pregnancy or having an abortion.  See Rachel
K. Jones et al., Contraceptive Use Among U.S. Women Having Abortions in 2000-2001, 34 Persp. on Sex & Reprod. Health 294, 300 (2002) (estimating
51,000 abortions were prevented in 2000 because of emergency contraceptive use).  Moreover, despite the millions of women who have used emergency contraception, there have been no reports of serious side effects or contraindications that would endanger women's health.  World Health Organization,
Emergency Contraception: A Guide for Service Delivery (1998), at http://www.who.int/reproductivehealth/publications/FPP_98_19/FPP_98_19_table_of_contents_.en.html

Access to Emergency Contraception Is Particularly Critical for Sexual Assault Survivors.

Over-the-counter access to emergency contraception is especially important for sexual assault survivors.  Every year, approximately 25,000 pregnancies
occur because of sexual assault.  See Felicia Stewart et al., Prevention of Pregnancy Resulting from Rape:  A Neglected Preventive Health Measure, 19
Am. J. Preventive Med. 228, 228 (2000).  Emergency contraception could prevent approximately 22,000 of these pregnancies.  Id. at 229.  Yet in many
areas, over two-thirds of hospital emergency rooms fail to provide emergency contraception to sexual assault patients routinely.  See Ashlesha Patel et al.,
Shouldn't All Victims of Sexual Assault Be Offered Emergency Contraception?, 99 Obstet. Gynecol. 29S (Supp. 2002); Clara Bell Duvall Reproductive
Freedom Project of the ACLU of Pennsylvania, Fact Sheet: Emergency Contraception Services for Rape Victims in Pennsylvania Hospitals (2001), at http://www.aclupa.org/duvall/pubs/ecinpa.html; Texas Abortion & Reproductive Rights Action League, Where Can a Woman Go?: Reproductive Services in
Texas Hospitals (2001).  The prescription requirement serves as a major barrier to access to emergency contraception for sexual assault survivors in these
areas.  If a woman is denied access to emergency contraception in the emergency room to which she is initially brought, she must then somehow track
down another doctor, answer more personal and painful questions, and find a pharmacy to fill her prescription, all within 72 to 120 hours of the assault.  
The difficulty of her search may be compounded by her own economic or geographical limitations.  She must do all this while dealing with the trauma of
the assault.  Ready availability of emergency contraception without a doctor's prescription would mean that at least one injury from the assault, the possibility
of pregnancy, could be quickly and safely alleviated.

Furthermore, for rape survivors who do not want to reach out to a doctor, because of shame, fear, or other personal issues, requiring a prescription to obtain emergency contraception may be tantamount to a complete denial of the critical drug.  Women should not be forced to report an assault to obtain a prescription
for emergency contraception.  Over-the-counter access to emergency contraception would ensure that sexual assault survivors could receive the treatment they
need while maintaining anonymity if they so desire.                          

Approving over-the-counter access to Plan B will promote public health, prevent unintended pregnancies, and reduce abortions.  For these reasons, we urge you
to support the conclusions of the FDA's two advisory committees by approving this petition.   

Sincerely, 

Laura W. Murphy
Director

Gregory T. Nojeim
Associate Director and Chief Legislative Counsel