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 : EC1560
Submitter : Ms. Jaclyn Sweeney Date & Time: 10/31/2005 11:10:05
Organization : Ms. Jaclyn Sweeney
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
This 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? We agree and the data indicate that access to emergency contraception will not encourage promiscuity or that EC would lessen the routine use of contraception.