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 : EC2085
Submitter : Ms. Laura Borst Date & Time: 10/31/2005 06:10:26
Organization : Feminist Majority/People for the American Way
Category : Individual Consumer
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?
I don't believe in not requiring prescriptions for one group, and exempting others from prescriptions. I believe this could be discriminatory. I think there should instead be labelling if drugs have different effects on some subpopulations from other groups.
B. If it could, would it be able to do so as practical matter and, if so, how?
I don't believe limitting sales to one subpopulation is practical. It would be difficult to enforce because it would involve pharmacists determining whether particular, individual consumers are members of subpopulations and this could be difficult to implement.
I believe emergency contraception products should be allowed over-the-counter, rather than prescription, status. There is a short interval when emergency contraceptives are effective in preventing pregnancy. Emergency contraceptives, also known as morning-after pills, can prevent the need for surgical abortions, which involve more complex and riskier procedures. Also, many women who need emergency contraceptives have been raped, and pregnancies could add to the trauma of rape.