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 : EC1412
Submitter : Mrs. Marcy St.John Date & Time: 10/28/2005 03:10:16
Organization : [retired teacher]
Category : Other Organization
Issue Areas/Comments
I write to you as a mother, a career educator in the public schools, and an active Christian.

The latest tactic to further delay making the correct decision to approve universal, over-the-counter availability of emergency contraception is an insult to all women. It further discredits the Food and Drug Administration as a responsible, professional science-based organization. The proposal to restrict access of EC OTC to women 16 and under makes no rational or practical or medical scientific sense. Determination of the safety and effectiveness of emergency contraception, with the added public health value of preventing unintended pregnancies, no matter the age of the woman, should be primary criteria for making this decision. What could possibly be the public health value in restricting access to adolescents ill-prepared emotionally and physically to carry a pregnancy to term? It *IS* a question of public health, not an issue of privately held but publicly legislated morality.

Access to emergency contraception will not encourage promiscuity or that EC would lessen the routine use of contraception. If we want to prevent the termination of pregnancies, we MUST prevent unintended pregnancies. No amount of legislation or publicly proclaimed morality will eliminate abortions. Only effective contraception, standard and Plan B, will reduce the number of terminated pregnancies.

It *IS* possible to be pro-choice and pro-faith, both. Visit www.rcrc.org, the website of the Religious Coalition for Reproductive Choice. Anti- choice is *NOT* the only option!!

Thirty-nine nations have made emergency contraception available without prescription, and 8 states in the U.S. have now adopted a process to streamline access of emergency contraception. The FDA's delay and ill-advised intention to restrict access to women 16 and younger is unacceptable and intolerable. Please make the decision to allow emergency contraception available to all women, all ages, without restrictions.