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 : EC862
Submitter : Mrs. Joann Lander Date & Time: 10/17/2005 10:10:26
Organization : Mrs. Joann Lander
Category : Drug Industry
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?
Yes it should.
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?
Yes it should
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
I don't think so, I think the FDA isn't confused it's just bowing down under political pressure
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?
Yes, not unlike we card for cigerattes and alcohol.
B. If it could, would it be able to do so as practical matter and, if so, how?
yes, of course.
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, I think the FDA is trying to make this harder than it has to be
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
If you have an age restriction then enforce it, but let's now make this seem like it's rocket science.
GENERAL
GENERAL
Emergency Contraception should be available over the counter for all women, but if you do it just for 16 and older then at least some women could avoid unintended pregnancies.