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 : EC877
Submitter : Ms. Ravenna Oakes Date & Time: 10/17/2005 10:10:01
Organization : Ms. Ravenna Oakes
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?
Only if it is not already adequately clear, which it may well be. Frankly, I would think that an OTC approval would be sufficient to permit both Rx and OTC sales.
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?
Not unless there is substantive confusion, preventing needed actions, likely to extend beyond this particular product.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
I can't answer whether FDA is confused or not.
C. If so, would a rulemaking on this issue help dispet that confusion?
That's difficult to say.
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?
A lawyer would have to answer that, but I would think that refusing to supply a product deemed fully safe OTC would invite legal action to reverse that decision. In this case that seems pointless, provocative, and self-destructive. In the absence of any medical objections or concerns for the use of this product in girls under 16, and considering the safe worldwide use without such restrictions, it is difficult to justify such a decision.
B. If it could, would it be able to do so as practical matter and, if so, how?
Possibly, just as cigarettes and liquor sales are proscribed for underage people. Yes, just as with liquor and cigarettes, others could purchase them
for younger people, at the risk of prosecution if discovered. This drug is surely less toxic for children than alcoholic beverages, and much less risky (and harmful to children) than pregnancy and childbirth.
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?
I can't think why not, if they are the identical product.
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
In the compelling interests of U.S. citizens, I believe it is vital to provide this product over the counter, preferably to all consumers, as recommended by FDA and other scientists. Logistics and legalities can be resolved without fanfare if there is adequate motivation to do so.