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 : EC1131
Submitter : Ms. Kim Clark Date & Time: 10/27/2005 02:10:01
Organization : Ms. Kim Clark
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?
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).

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.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
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.
C. If so, would a rulemaking on this issue help dispet that confusion?
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.

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?
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.