|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 :||EC1765|
|Submitter :||Mrs. Robin Butler||Date & Time:||10/31/2005 03:10:21|
|Category :||Other Organization|
| 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?|
| 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.
Some 39 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, and no restrictions.