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 : EC1403
Submitter : Ms. Sara Sherman Date & Time: 10/28/2005 03:10:48
Organization : Ms. Sara Sherman
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
Stop delaying approval of over-the-counter emergency contraception. This is a much needed resource for women and should be universally available to all post-pubescent females, regardless of age. The drug has been ruled safe and effective, and therefore there is no sound reason for the FDA to delay its approval. To do so is to sully the reputation of the FDA as a principled scientific institution devoted to protection the good of the population.