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 : EC2162
Submitter : Ms. Susan Hagius Date & Time: 10/31/2005 06:10:55
Organization : Ms. Susan Hagius
Category : Individual Consumer
Issue Areas/Comments
1
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?
Don't know
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?
Don't know
2
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?
Why not?
B. If it could, would it be able to do so as practical matter and, if so, how?
The same way it limits other prescription drugs.
3
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?
I would think it is better to differentiate by packaging.
GENERAL
GENERAL
I am appalled at FDA's constant delays in permitting EC to be sold over the counter without a prescription. EC is most effective (95%) if taken within 24 hours after unprotected sexual intercourse - when a condom breaks, birth control is not used, or if a sexual assault occurs. It is increasingly difficult to see a physician at all, especially for underprivilidged people. Only rarely is it possible within 24 hours. Moreover, requiring a physician's prescription increases the total cost of EC dramatically.
Please stop allowing politics to interfere with women's health and safety.