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 : EC1232
Submitter : Ms. Catherine Harrison Date & Time: 10/27/2005 05:10:21
Organization : Ms. Catherine Harrison
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?
No. It should stop delaying. It is time now to approve over the counter EC with no prescription required and no age requirement.

"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.

More than 70 professional medical and public health associations including the American Medical Association, the American College of Obstetricians and Gynecologists and the Society for Adolescent Medicine have endorsed EC access for women of all ages. The American Academy of Pediatrics has urged its members to "help ensure that all adolescents have knowledge of and access to contraception, including barrier methods and EC supplies."
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The debate over whether there should be an age limit has caused a delay.
C. If so, would a rulemaking on this issue help dispet that confusion?
No. It is unnecessary. No one should be confused.
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?
No. The FDA needs to do its job and not concern itself with morality issues.
B. If it could, would it be able to do so as practical matter and, if so, how?
It could not. And it should not invade anyone's privacy.
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 is no need for a prescription version if the OTC is universally available.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
It would never be inappropriate.
"Some 39 nations have made emergency contraception available without prescription and 8 states in the U.S. have now adopted a process to streamline access of emergency contraception. The FDA's delay and ill-advised intention to restrict access to women 16 and younger is unacceptable and intolerable. Please make the decision to allow emergency contraception available to all women, all ages, and no restrictions."

This paragraph, composed by NOW, sypports my view, in a much more polite way than I would have phrased it myself.

The FDA has no right to restrict the rights or privacy of any woman. Stop the delay.