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 : EC421
Submitter : Dr. Michael Brown Date & Time: 09/20/2005 04:09:05
Organization : Temple University Physicians
Category : Health Professional
Issue Areas/Comments
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?
If convenience stores can limit the sale of tobacco to minors and grocery stores can limit the sale of alcohol to minors, then why can't pharmacies limit the sale of Plan B to females 16 and under? Alcohol and tobacco have been proven to be much more dangerous than emergency contraception!
B. If it could, would it be able to do so as practical matter and, if so, how?
It would be as practical as other federal agencies enforce such a limitation of sales of tobacco and alcohol to minors.
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?
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Emergency contraception has been proven in large studies to be safe and effective. It is not teratogenic. It prevents up to 89% of unintended pregnancies due to contraceptive failure or lack of contraception. It gives women much more control over their health. It has NOT been proven to lead to an increase in unsafe sex practices, nor has it been proven to lead to increased sexual activity.
This process appears to be purely political, and I have lost all my confidence in the FDA under its current leadership.