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 : EC585
Submitter : Ms. Jan Harper Date & Time: 10/12/2005 06:10:55
Organization : WOMEN'S HEALTH ISSUES
Category : Other Organization
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?
3
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
I think the whole idea of selling abortifacient drugs over the counter jeopardizes women's health and has led to an increase in std's. The FDA have no control over the regulations that prohibits sale to minors either!