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 : EC1181
Submitter : Ms. Raquel Rodriguez Date & Time: 10/27/2005 04:10:07
Organization : Ms. Raquel Rodriguez
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?
No. The major professional medical organizations believe this emergency contraception product should be available over the counter.
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?
(same as above)
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The FDA itself confused the issue by trying to add an age restriction.
C. If so, would a rulemaking on this issue help dispet that confusion?
No, that would be a waste of time.
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?
If a girl is old enough to get pregnant, she's old enough to protect her health and life by using emergency contraception. This is not the same as buying alcohol or cigarettes. In fact, it's the opposite.
B. If it could, would it be able to do so as practical matter and, if so, how?
This sounds like the Gestapo to me -- wasting taxpayers money to chase down a teen ager who's smart enough to take precautions so she can have a future. Perhaps we should also fund tracking down the perpetrator of the "crime," the boy or man who might have impregnated her, possibly against her will, and punishing him?
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?
No need, if it's available over the counter.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
No such circumstances exist.
GENERAL
GENERAL
This whole debate is a ploy. It does discredit to the FDA, which historically acts on a scientific basis, to become the tool of religious fascists.