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 : EC742
Submitter : Ms. Katherine Dalesandre Date & Time: 10/13/2005 08:10:55
Organization : Ms. Katherine Dalesandre
Category : Individual Consumer
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?
Yes, that could be enforced the same way the sale of alcohol is enforced, by checking identifications. There is no reason that an OTC product should be restricted to prescription only if a consumer can safely and effectively follow the usage directions on their own.
B. If it could, would it be able to do so as practical matter and, if so, how?
Asking for identification of the buyer is the simplist and most effective manner. Even with prescriptions, there must be a level of trust that the person receiving the prescription will only use it in the manner it is meant to be. In the same way, there will be a level of trust in the buyer of the OTC product. There are no guarantees that anything is used in the manner prescribed, but there must be trust in the consumer that they will act in the correct and lawful manner.
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?
In order to cut down on confusion for the consumer, they should be marketed in packaging that is at least slightly different.
I really see this current process as a delay by the FDA to act based on political reasons, not medical or legal ones. From all of the information I have read, it does not appear that the release of Plan B as an OTC product goes against any legal or medical directives. The FDA is obligated to act in a way that provides the general public the best products in the best manner. Keeping Plan B within prescription channels only does not fulfill those obligations. If indeed the FDA is going to continue to act as an unbiased body, then current political opinions do not have any place in the FDA approval process. By continuing to delay the release of this drug, the FDA is failing in its duties to the general public.