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 : EC2140
Submitter : Ms. Patricia R Robinson Date & Time: 10/31/2005 06:10:50
Organization : Brook Lane Health Services
Category : Health Professional
Issue Areas/Comments
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?
FDA should simply approve without further ado OTC sale of emergency contraception. No prescriptions required for any age group. .
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The FDA's attempt to limit access by age has muddied the waters about what should be a clear-cut decision to approve OTC sale of a safe and effective emergency contraception.
I happen to be a psychotherapist. I know there are young teens who are impregnated by fathers, uncles, you name it. They need to have this safe method available in such cases.
C. If so, would a rulemaking on this issue help dispet that confusion?
It appears to me that a proposed rule and review process will only drag out the time period before a final decision is made regarding the use of this drug OTC. I also personally believe that the drug companies don't want to give up another prescription drug to line their own pockets.