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 : EC2088
Submitter : Dr. Carrie Klima Date & Time: 10/31/2005 06:10:24
Organization : Dr. Carrie Klima
Category : Health Professional
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?
yes, while Plan B contains the same ingredients in some oral contraceptives, it is not sole available in any other form than Plan B. There are many examples of drugs in which some component may be a prescription item and the other ingredient not. for example Tylenol with codiene, higher dosages of otc medications such as ibuprofen.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes. No one on the scientific committee had any problem evaluating the safety and effectiveness of the drug. The FDA's role is to guarantee a drugs safety which has been demonstrated.
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 and there should be no reason to as Plan B has no contraindications in the adolescent population. It has been supported by the AAP.
B. If it could, would it be able to do so as practical matter and, if so, how?
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?
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
The FDA's role should be to evaluate the scientific evidence presented to its own panels of scientists and evaluate drug safety and effectiveness. Politics should not play a role in whether a drug is available to the public. Plan B would help to reduce some of the 3 million unintended pregnancies by preventing pregnancy, and reducing the need for abortion.
This agency should not be playing politics with the lives of women in this country. Listen to your own experts. Make Plan B OTC