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 : EC1248
Submitter : Dr. Kristine Westrom Date & Time: 10/27/2005 05:10:52
Organization : Dr. Kristine Westrom
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?
Emergency contraception should be available to all women without delay.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
apparently there is at the FDA! Emergency contraception should be available to all fertile females regardless of age.
C. If so, would a rulemaking on this issue help dispet that confusion?
No.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a matter of law?
Yes. This is a bad idea, but enforceable: for example, sales of cigarettes.
GENERAL
GENERAL
Emergency contraception should be available to all fertile females. Stop the delaying tactics and work in the public interest, based upon science! The FDA is losing credibility by playing politics.