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 : EC1133
Submitter : Dr. Sylvia Fine Date & Time: 10/27/2005 02:10:30
Organization : Dr. Sylvia Fine
Category : Health Professional
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?
FDA should do whatever it takes to get emergency contraception available OTC. There is good eveidence that young women can take the product as safely as older women, so the whole controversy is politically, not medically driven.
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?
This seems to be the same ? as above, with different typos.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
There is significant confusion between science and religion.
C. If so, would a rulemaking on this issue help dispet that confusion?
Put that issue aside and accept the drug for all ages.
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?
It's all a red herring. Just approve the product. We can't even keep kids from buying cigarettes, which are certainly more dangerous!
B. If it could, would it be able to do so as practical matter and, if so, how?
No.
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?
Yes. Otherwise it's just an excuse to raise the price higher than teens can afford.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
None
GENERAL
GENERAL
Please stop playing with the health and safety of teens for religious reasons. EC is not an abortifacient, so why make teens get to the point where they may feel they have to choose an abortion instead of a pregnancy?
Let's prevent unwanted and accidental pergnancies!