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 : EC1775
Submitter : Ms. Donna Turman Date & Time: 10/31/2005 03:10:05
Organization : Ms. Donna Turman
Category : Individual Consumer
Issue Areas/Comments
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?
The Food and Drug Administration should simply approve without further delay over-the-counter (OTC) sale of emergency contraception - with no prescriptions required for any age group. This obviates the need for any new rulemaking. The two advisory FDA committees that exhaustively reviewed data in December 2003 found that emergency contraception was safe and effective and consequently recommended OTC approval.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
I believe there has been significant and deliberat confusion regarding the FDA's interpretation of Section 503(b) of the act. Emergency contraceptive is safe and effective when used according to instructions. Politics and lack of knowledge on the part of the current administration's voter base should not impair the lives of women.
C. If so, would a rulemaking on this issue help dispet that confusion?
The FDA's job is to determine safety and efficacy, not to serve as the "morality police" on behalf of any special interest group. Further, groups with anti-contraception agendas could easily manipulate rules to harass or intimidate women who seek emergency contraception. It should be as available to women as condoms are to men. They serve the same purpose.

A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a matter of law?
Again, why is the FDA playing drug police for an approved drug? The suggestion of federal enforcement brings to mind federal agents pursuing 16 year olds concerned about an unintended pregnancy who in the act of obtaining emergency contraception are breaking a federal law. The absurdity is hard to exaggerate.

B. If it could, would it be able to do so as practical matter and, if so, how?
Making EC universally available would obviate the need for separate packaging.

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?
See the answer above.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
The Food and Drug Administration is a responsible, professional science-based organization which is bending to pressure from what must be the most extremist administration in this country's history. The proposal to restrict access of EC ? OTC to women is discriminatory, harassing, and unnecessary. 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? Especially victims of assualt?

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. The U.S. is certainly NOT a leader in the field of contraception and family care. 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.