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 : EC2199
Submitter : Mrs. Karen Weir Date & Time: 10/31/2005 06:10:28
Organization : Mrs. Karen Weir
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 should approve-without delay-the OTC sale of emergency contraception (EC) with NO STRINGS ATTACHED! No prescription for specific age groups....This obviates the need for new rulemaking.
Two FDA committees found EC safe and effective and recommended OTC approval. The Advisory Committee rejected the age restriction proposal. The agency's move to restrict access to younger women is contrary to the recommendations of the majority of respected medical professionals and to the government's own stated policy.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The FDA's intent to limit access of OTC EC by age has confused the
issue, which should have been clear cut: approve OTC sale of this
safe and effective EC and you won't need to be concerned with confusion.

C. If so, would a rulemaking on this issue help dispet that confusion?
A proposed rulemaking would only serve to delay implementation of OTC
EC. It is completely unneccessary.
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?
It probably could, as is now done with alcohol, tobacco, and firearms. However, the FDA is not the morality police. The FDA should stick to science and eschew politics. Safety and efficacy are
concerns for the FDA and EC OTC would fit the bill.
B. If it could, would it be able to do so as practical matter and, if so, how?
It would be impractical, embarassing, and insulting for Federal agents to demand to check d.o.b.s for any age woman seeking EC. Ditto
for pharmicists. The whole notion of limited sale is absurd.
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?
Making EC universally available as an OTC would eliminate the need for separate packaging.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
There would not be any circumstance that would be inappropriate for a single package.
Give us safe and effective EC OTC. It is the responsible thing to do.