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 : EC1783
Submitter : Ms. Pam Rolfes Date & Time: 10/31/2005 03:10:35
Organization : Ms. Pam Rolfes
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
As someone who is concerned about women?s access to safe and medically necessary contraceptives, I urge the FDA to end its egregious delay of the decision to switch Plan B?s drug status to over the counter (OTC). The FDA?s latest move?issuing a request for public comments on such self-explanatory issues such as whether the FDA has the authority to approve a drug in both prescription and OTC form and whether such a limitation would be enforceable?is merely a stall tactic that compromises women?s reproductive health options.