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 : EC2101
Submitter : Dr. Anne Davis Date & Time: 10/31/2005 06:10:48
Organization : Columbia University Medical Center
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?
I strongly believe that Plan B should be available over the counter for all women, young and older, who need it.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes. The confusion stems from the difficulty in explaining why a different healthcare standard should be applied to younger women and older women.
C. If so, would a rulemaking on this issue help dispet that confusion?
As above.
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?
This is not a sensible distinction. All women should have access to emergency contraception.
B. If it could, would it be able to do so as practical matter and, if so, how?
Not applicable.
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?
No opinion.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
No opinion.
I am dismayed at the entire process which has unfolded as we have waited for Plan B to be available over the counter. There is NO EVIDENCE that making EC available to minors has ANY negative health consequnce, including changing sexual behavior or use of other contraceptives. Teens are our most vulnerable population; in teens the consequences of unintended pregnancy are the worst. I recommend, as a physician who practices obstetrics and gynecology among poor, young women, that PLan B become available OTC as soon as possible: to ALL women who need it.