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 : EC1083
Submitter : Ms. Judith Leconte Date & Time: 10/27/2005 11:10:10
Organization : Ms. Judith Leconte
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?
See General Comments section
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?
See General Comments section
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
See General Comments section
C. If so, would a rulemaking on this issue help dispet that confusion?
See General Comments section
2
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?
See General Comments section
B. If it could, would it be able to do so as practical matter and, if so, how?
See General Comments section
3
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 General Comments section
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
See General Comments section
GENERAL
GENERAL
10/21/05

As someone who is concerned about women's access to safe and medically necessary contraceptives, I urge the FDA to end its egregious delay of the decision to switch Plan B's drug status to over the counter (OTC). The FDA's latest move-issuing a request for public comments on such self-explanatory issues such as whether the FDA has the authority to approve a drug in both prescription and OTC form and whether such a limitation would be enforceable-is merely a stall tactic that compromises women's reproductive health options.

Contraceptives are a fundamental element of basic health care for most sexually-active women of childbearing age. Plan B, a safe and effective form of contraception, decreases the risk of unintended pregnancy resulting from unprotected sex or contraceptive failure by 89%. For women who want to avoid the health, economic, and social costs that unintended pregnancy carries for them, their children, and society as a whole, easy access to this drug is essential. For Plan B to be effective, women must be able to take it quickly, as the efficiency rate decreases dramatically after 12 hours following unprotected sex, birth control failure or sexual assault. Because it is often not possible to quickly schedule an appointment with a health-care provider who will write a prescription, making the drug available OTC is essential to the many women who would not otherwise be able to access it.

Plan B should be made available OTC to women of all ages. The claim that easier access to young women will result in increased rates of unprotected sex among adolescents is simply unsubstantiated. Moreover, the FDA has always treated all women of child-bearing age the same when evaluating reproductive health products, making the option of restricting OTC drug status by age an unjustified aberration.

However, the alternative that is currently up for consideration-allowing Plan B to be available OTC for women only above a certain age-though far from ideal, is still practical and legal. The FDA has approved other medications as OTC for those only over a certain age and did so without repeatedly delaying the approval process.

The FDA has long been hailed as an independent entity that promotes public health through science and evidence, not ideology and politics. The fact that women have had to wait for more than two years for the FDA to issue a decision on the Plan B application is unacceptable. Please make women's health the FDA's first priority by ending this undo delay.

Thank you for your consideration.