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 : EC1250
Submitter : Mrs. Brianna Schimmer Date & Time: 10/27/2005 05:10:07
Organization : Mrs. Brianna Schimmer
Category : Individual Consumer
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?
The FDA needs to approve without delay over-the-counter sale of emergency contraception - with no prescriptions required for any age group.
The two advisory FDA committees that exhaustively reviewed data in December 2003 found emergency contraception was safe and effective and consequently recommended OTC approval.
When the age restriction was suggested at the December Advisory Committee meetings, the FDA staff noted then that it has been the policy of the Division of Reproductive and Urologic Drug Products to make no distinction between post-pubescent adolescents and adult women insofar as contraceptive use is concerned. The Advisory Committee members then rejected the age restriction proposal.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes! Why is there a delay in approval over such a clear issue? It appears the FDA wants to restrict access to OTC emergency by age, risking women being denied access to safe emergency contraception.
C. If so, would a rulemaking on this issue help dispet that confusion?
No, it would just slow it down further. Women's health will be jeopardized by the red tape.
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?
The FDA is supposed to determine effectiveness and SAFETY not what "ought" to be. Limiting sale by subpopulation is ridiculous. Black women are a subpopulation, would they be denied by future FDA regulations??? Restricting by age would be enforceable only by requiring ID for purchase which is a clear violation of a woman's right to privacy with regard to medical care.
B. If it could, would it be able to do so as practical matter and, if so, how?
NO it would not, could not, and should not. This is ludicrous!
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?
If it's the same thing, it wouldn't require seperate packaging.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Under no circumstances would there be a need for seperate packaging.
The FDA has sadly let down American women by not taking steps to ensure all women have access to OTC, regardless of age.