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 : EC938
Submitter : Dr. Ronald Samuels Date & Time: 10/27/2005 08:10:38
Organization : Dr. Ronald Samuels
Category : Health Professional
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?
As a pediatrician, I can unequivecally state that approving Plan B for OTC use is not only safe, but needed. Plan B is a safe, effective, and easy- to-use contraceptive option that will help reduce the need for abortion. Teenagers in particular find it difficult to access birth control. Furthermore, restricitions on access to birth control have no affect on sexual activity, therefore meaning that such restrictions just increase unintended pregnancies and abortions.

Women in this country deserve the same unencumbered access to Emergency Contraception that women in 39 other countries around the world already enjoy. Millions of women, including survivors of rape, stand ready to benefit from increased access to this backup method of birth control.

Every day that the FDA delays making a decision to allow increased access to this second-chance prevention medication, the more women are put at risk of facing an unintended pregnancy. Americans deserve an independent FDA that will protect our health and make public health decisions based on science and medicine, not ideology. To sacrifice the health and lives of women to promote an ideological agenda is not only wrong, but also unconscionable. Major medical groups along with the FDA's own experts overwhelmingly support this move

There is clearly no legally defensable reason not to approve OTC statuts for emergency contraception.