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 : EC1848
Submitter : Ms. Sharon Dupree Date & Time: 10/31/2005 03:10:10
Organization : Ms. Sharon Dupree
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 Food and Drug Administration should simply approve without further delay over-the-counter (OTC) sale of emergency contraception - with no prescriptions required for any age group. This obviates the need for any new rulemaking. The two advisory FDA committees that exhaustively reviewed data in December 2003 found that emergency contraception was safe and effective and consequently recommended OTC approval. The need to restrict access to young women, 16 years of age and younger, has been deemed to be unnecessary by the government's own stated policy and respected health proessionals.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
There's no real confusion. The FDA attempted to confuse the public and it didn't work. There should have been a clear-cut decision for approval based on the evidence and not the confusing ideolgy of those who personally oppose OTC.
C. If so, would a rulemaking on this issue help dispet that confusion?
It would be unnecessary to require a rulemaking.

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's job is to determine safety and efficacy, not to take sides in an ideological morality debate. It's innapropriate to deny young woman this safe way of avoiding pregnancy and will cut down on self-induced and back room abortions.
B. If it could, would it be able to do so as practical matter and, if so, how?
It would be intrusive and absurd to bring in Federal Agents under federal law to police young woumen for taking contraception medication that would be legal for them if they were older, based on nothing more than the ideology of those whose personal beliefs are in conflict with the OTC prodocts. These products are not mind altering or dangerous to health.
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?
There's no reason to package them separately if EC is made available universally.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
A single package would be appropriate for packaging
The delaying tactics taken by the FDA are unconscionable. It makes no medical sense to deny OTC producys to young or legally adult women. Safety, effectiveness and the prevention of unintended pregnancies should be the primary criteria considered for approval. Adolescents, especially, are ill-prepared for pregnancy, physically and emotionally. There is no evidence that availability of these products will lead to promiscuity or would lead to avoidence of other contraception methods.