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 : EC971
Submitter : Dr. Rael Nidess, M.D. Date & Time: 10/27/2005 09:10:16
Organization : Dr. Rael Nidess, M.D.
Category : Health Professional
Issue Areas/Comments
It has become clear that the post-coital birth control method "Plan B" has been fully evaluated by the scientific/medical resources of the FDA and has been found both safe and effective for its medical indication when dispensed OTC without limitations. It has also become painfully evident that the FDA's administrative levels have been corrupted by political and religious influence to prevent the OTC dispensation of Plan B.

I request that the FDA approve the OTC sale and use of Plan B immediately and without further politcally motivated delay.

Rael Nidess, M.D.
Marshall, TX