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 : EC1048
Submitter : Ms. Margaret Tovrea Date & Time: 10/27/2005 10:10:44
Organization : Ms. Margaret Tovrea
Category : Individual Consumer
Issue Areas/Comments
Plan B should be made available OTC to women of all ages.

The claim that easier access by young women will result in increased rates of unprotected sex among adolescents is simply unsubstantiated. Moreover, the FDA has always treated all women of child-bearing age the same when evaluating reproductive health products, making the option of restricting OTC drug status by age unjustified.

However, the alternative that is currently up for consideration - allowing Plan B to be available OTC only for women above a certain age - though far from ideal, is still practical and legal.

The FDA has approved other medications as OTC for only those over a certain age, and did so without repeatedly delaying the approval process.

The FDA carries a mandate to be an independent entity which promotes public health through science and evidence, not subject to ideology and politics. The fact that women have, at this juncture, had to wait for more than two years for the FDA to issue a decision on the Plan B application is unacceptable, and, at the very least, does appear to be influenced by the non-science of ideology and politics.

As comparative - in several ways, parallel - situations, let me remind you of the ideological and political forces which instituted and enforced: slavery; segregation; segments of society not having rights of property or of the vote; red-lining in lending. Most thinking people will have numerous additions to this list.

Were not all of the above the products of the then-current in-power ideologies and/or politics?

The FDA's having changed standard process and procedures has already caused an undue delay in the decision. Treat this medication in equity with any other medication being considered for OTC status.

Please make the general issue of HEALTH - not ideology - the FDA's priority.

Thank you for your consideration.