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 : EC1494
Submitter : Ms. Laura Erley Date & Time: 10/28/2005 04:10:23
Organization : Ms. Laura Erley
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?
I believe the FDA should approve emergency contraceptive without prescription to WOMEN OF ALL AGES.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The approval of this safe and effective emergency contraception has been unnecessarily held up by the question of limiting access to this drug by age.

C. If so, would a rulemaking on this issue help dispet that confusion?
No, a decision should be made on the issue now.
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?
When the matter is one of personal health and welfare, it is outrageous to limit the drug to particular "subpopulations," limiting its use and efficacy, and unnecessarily burdening potential buyers and providers with redtape. The FDA was created to vouchsafe for the safety of pharmaceuticals, not to act as an enforcement body subject to political steering.
B. If it could, would it be able to do so as practical matter and, if so, how?
This would be costly and an unnecessary burden to the FDA, the government, the taxpayer, and the purchaser.
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?
Making EC universally available would obviate the need for separate packaging.

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
A single package is completely reasonable.

The FDA should function as a SCIENCE-BASED, professional organization, with the chief mission of safeguarding public health. The proposal to limit access to EC makes no rational, medical, or scientific sense.