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 : EC1595
Submitter : Mrs. Stephanie Schulte Date & Time: 10/31/2005 01:10:40
Organization : Mrs. Stephanie Schulte
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 emergency contraception over-the-counter immediately and without delay.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The FDA seems to be trying to confuse the issue when it should be fairly straightforward.
C. If so, would a rulemaking on this issue help dispet that confusion?
Approve EC for OTC use immediately.
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?
For EC, there should be no limits on a particular subpopulation. Doing so smacks of sexism. We don't legislate condom sales to young men because it would cause them to be promiscuous.
B. If it could, would it be able to do so as practical matter and, if so, how?
It would be very impractical and an intrusion of 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 different packaging if EC is made 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?
I strongly urge the FDA to approve EC for OTC availability to all, regardless of age.