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 : EC1635
Submitter : Mrs. Joy Eller Date & Time: 10/31/2005 01:10:08
Organization : Mrs. Joy Eller
Category : Health Professional
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?
Sir,
Please note that OTC has been proven safe time and again in other countries, and I see no good reason to continue to deny women acces to it over the counter and without a prescription in the United States. Politics should not unduly play with human life but be of a help toward better living for all. Please clear the way today.
Thank You
Joy Eller