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 : EC2182
Submitter : Dr. michele curtis Date & Time: 10/31/2005 06:10:33
Organization : Dr. michele curtis
Category : Health Professional
Issue Areas/Comments
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?
Not without Congressional legislation to give it the authority to enforce that. And how would an OTC product be considered OTC if it was available to a subpopulation by prescription only? And who would be responsible for the process of enforcement itself- local authorities? The local police departments are stretched to the maximum already- they are not going to stand around and patrol pharmacies nor should they be asked to do so. The concept of selling an OTC only to a population above a certain age harkens back to the days when you had to be over 18 to buy condoms. Maybe we should consider restricting the sale of Tylenol or aspirin to adults only as they are a mode of suicidal exression among youth.
B. If it could, would it be able to do so as practical matter and, if so, how?
It would not be a practical matter and would only be enacted as a political tool in the guise of a policy action.
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?
It is my understanding that the only reason some OTC products are still available as prescription is so that they can be covered by health pharmacy benefits or plans. They should be available in the same package- why should the manufactureer be forced to bear costs incurred arbitrarily by the FDA?
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
When there is wide differences between the dose of single agent(s) in the packages. For example, if the OTC drug has a dose of 5 mg per pill but the prescription drug has a dose of 50 mg per pill, the packages should be different.
Emergency contraception is just that: the prevention of pregnancy. The semantic conversion of its action into that of an abortifacient is a classic example of hijacking language for political ideologies. The capricious decision on the part of the chair to ignore the recommendations by the vast
majority of acclaimed scientists and clinicians in order to serve an ideologic mission is nothing short of obscene and was a clear demonstration of the rape of science by politics.

The FDA is charged with determining the safety and efficacy of pharmaceutical and biological agents and devices. Emergency contraception has been repeatedly proven to be both safe and effective. In prolonged doses, aka oral contraception, there are no burning concerns that young women may need it for hormonal therapy of menses starting with menarche (average age of 12) and it has a long history of being used for that purpose, as well as for contraception. To expose a young woman, recently menarchal or otherwise, to a short term dose in order to prevent a pregnancy is so devoid of overwhelming risks as to be inconsequential.

The FDA made a Faustian deal when it buckled under pressure from this Administration to yield to politics instead of scientifically sound policy. If it made a deal with one ''player', who is to say it won't make deals with other 'players' such as large corporate interests?

Emergency contraception should be made available over the counter- not behind the counter-immediately. It's good science and it's good policy.