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 : EC1132
Submitter : Ms. Margot Clarke Date & Time: 10/27/2005 02:10:32
Organization : Ms. Margot Clarke
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?
The FDA should stop jerking American women around (and letting extremist pharmacists insert themselves between patients and legally prescribed drugs) and approve this product for over-the-counter sale immediately.
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?
Is this a different Section A than above?
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Confusion and dismay - the FDA is no longer a trusted agency whose "interpretation" or decisions are drawn from scientific study.
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?
Such a limitation is unnecessary and counter-productive and part of a stalling tactic that is shocking behavior for the FDA.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?
YES, of course, if necessary (but it's not).
GENERAL
GENERAL
I would like to respectfully say that your actions and especially inaction on this issue is irresponsible and disheartening. Everything you have learned in years of study has shown that this product is safe, effective, not subject to misuse, and offers a clear benefit to the consumer. Experts estimate that the number of abortions in this country could be reduced by up to 50% if emergency contraception would widely available. There are horrifying numbers of incidents of rape, and the victims of that crime should never have to worry about access to this product. And nowadays we actually see cases of pharmacists refusing to fill prescriptions for EC.

The argument that minors would misuse this product is ludicrous; anyone who knows the mechanism of EC knows that this is not something that anyone would find convenient to use for birth control, much less anything else. I firmly believe that trying to keep this restricted to prescription- only for minors is unnecessary and being used only to further delay the overdue change to OTC.

Please, restore the status of the FDA as an objective and honorable agency that uses proper scientific enquiry to protect and enhance the lives of American consumers. Stop the delaying tactics and political posturing and move ahead on this issue. Make Plan B available immediately to everyone who needs it.

P.S. Your so-called 'detailed description' of the issues for comment contains absolutely no details at all and is nothing but the same sentences that appear on this page. Perhaps it is your intention to keep the details of this disgraceful episode in the FDA's history hidden?