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 : EC995
Submitter : Ms. Ellen Vessels Date & Time: 10/27/2005 09:10:44
Organization : Students Against Sexism in Society of Knox College
Category : Academia
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?
There is no reason to restrict OTC access to any certain subpopulation, unless there is a severe risk for patients with other health problems that might be aggravated by the OTC drug, or if there is a severe risk of drug interaction with other drugs the patient might be taken. Nonetheless, there is probably no way to enforce such limitations, so you may as well make the drug available OTC for everyone.
My comment regards the constant delay on the decision of OTC status for Emergency Contraception. All concerned in the FDA should not think that they are pulling the wool over the eyes of American women. It is clear that politics, not health and science, are swaying FDA decisions at this point. This is obvious because the FDA has disregarded the recommendation of it's own expert panel.
EC must be made available over-the-counter because it is a time-sensitive drug, and because it will prevent thousands of unwanted pregnancies, births, and abortions per year. Stop the delay, and approve EC OTC.