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 : EC2091
Submitter : Ms. Patricia Simon Date & Time: 10/31/2005 06:10:44
Organization : Ms. Patricia Simon
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?
Probably not. Equal protection.
Plan B emergency contraception should be sold over the counter. The repeated and ongoing delays resulting from political pressure should be ended. Women must be free to control their own reproductive decisions. Preventing OTC sale of Plan B is nothing more than a veiled attempt to let other people control this decision making. This is anti-woman and anti-American. Let those with a concern decide for themselves, and NO ONE ELSE, whether they wish to purchase such a product. The products are demonstrably safe and the delays must end.