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 : EC838
Submitter : Mrs. Elizabeth Caskie Date & Time: 10/13/2005 10:10:40
Organization : Mrs. Elizabeth Caskie
Category : Individual Consumer
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?
don't know
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?
don't know
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The only confusion I see is that the FDA is currently attempting to serve two masters under the Bush administration: its public health mandate vs. rightwing religious zealots.
C. If so, would a rulemaking on this issue help dispet that confusion?
possibly
GENERAL
GENERAL
Approve Plan B as a non-prescription drug

I urge the FDA to approve "Plan B", also referred to as the "morning-after pill", as a non-prescription medication. I understand that the FDA found this drug safe and effective way back in 1999, and that your advisory committee overseeing Barr's application to go over-the-counter with this medication, overwhelmingly approved of the application, way back in December, 2003. Yet, the approval has been withheld, apparently for an ideological reason, and not any reason having to do with the medication's safety - which, of course, should be the exclusive concern of the FDA.

I understand further, though, that the sole ideological reason for resisting approval of going over-the-counter with Plan B, has actually been
disproven by studies: availability of Plan B has been demonstrated NOT to increase sexual activity among young teens. Thus, the only reason cited for withholding approval of OTC availability is without merit, according to the FDA's own uncontroverted studies.

Plan B is available over the counter or directly from a pharmacist in seventeen countries, including the United Kingdom, France, Switzerland, Scandinavia, Canada and Portugal. It is high time for the US joined the rest of the industrialized world in promoting women's health, and women's autonomy, by approving "over-the-counter" treatment for Plan B.

Thank you for your consideration.