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 : EC500
Submitter : Dr. Dana Stone Date & Time: 09/27/2005 08:09:08
Organization : ACOG
Category : Health Professional
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?
C. If so, would a rulemaking on this issue help dispet that confusion?
There seems to be enough confusion within the FDA, that no final ruling has been made on making Plan B available over-the-counter.
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?
I think it would be as enforceable as any other FDA ruling. The same enforcement methods could be used for these products as are used for tobacco and alcohol sales.
B. If it could, would it be able to do so as practical matter and, if so, how?
Yes. See above.
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?
The FDA should base its rulings on science, not politics. Plan B is a very safe medication. It does NOT interrupt an established pregnancy. Pregnancy can occur from an act of intercourse up to 3-5 days before ovulation. The theory is that taking the medication AS SOON AS POSSIBLE after unprotected intercourse or failure of another birth control method will prevent ovulation. Less likely is that it will prevent implantation of a fertilized ovum. I believe that the failures of the medication relate to ovulation that has already occurred. Further research will hopefully show this.