2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
FDA Comment Number : EC2205
Submitter : Mr. David Benfell Date & Time: 11/01/2005 12:11:44
Organization : Mr. David Benfell
Category : Individual Consumer
Issue Areas/Comments
I urge the FDA to approve Barr Laboratory's application to market Plan B over-the-counter. Easier and more prompt access to Plan B would help prevent unintended pregnancies, reduce abortions, and promote women's reproductive health and rights. The FDA's continued delay in reaching a decision on this application permits politics to trump science and amounts to a failure of the FDA to meet its obligation to promote and protect women's health.

I understand that Barr Laboratory's application to the FDA to make Plan B available over the counter has been stalled for over two years. This delay flies in the face of the FDA's own advisory committees' recommendations. Major medical groups also support making Plan B more readily accessible to women who need it, including the American College of Obstetricians and Gynecologists, the American Medical Association, and the American Public Health Association.

Over the counter availability of Plan B would ensure access to emergency contraception for the many women who need it. Nearly half of all pregnancies in the United States are unintended. Because emergency contraception must be taken within 72 to 120 hours after unprotected intercourse, ready access to emergency contraception is critical for women facing a potential unintended pregnancy. The current requirement that emergency contraception only be dispensed with a doctor's prescription acts as significant barrier to quickly obtaining this safe and effective method of birth control. That is why Plan B should be made available without a prescription.

I believe that the FDA's decision to limit the over the counter availability of Plan B to women seventeen years or older is unwarranted and will chill the ability of women of all ages to access Plan B. Imposing age restrictions on Plan B will likely lead stores that sell Plan B over-the- counter to impose mandatory proof of age requirements. Given Plan B's demonstrated safety record, such an invasion serves no legitimate purpose, and will only humiliate a woman who has just experienced contraceptive failure, unprotected sex, or sexual assault. The prospect of being forced to produce identification while in the process of purchasing a drug as personal and intimate as emergency contraception is likely to deter women of all ages from purchasing Plan B.

Finally, over-the-counter access to emergency contraception like Plan B is especially important for sexual assault survivors. Every year approximately 25,000 pregnancies occur because of sexual assault. Yet in many parts of the country, more than half of hospital emergency rooms fail to routinely provide emergency contraception to sexual assault patients. 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. 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. The FDA's continued refusal to act on Barr's petition evidences a willingness to place political gain over women's health. I urge you to approve over-the-
counter status for Plan B emergency contraception.