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 : EC767
Submitter : Dr. Patrick Yeung Date & Time: 10/13/2005 08:10:12
Organization : Georgetown University Hospital
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?
I do NOT think it is feasible to market the same drug for the same indication as both a prescription and an OTC product.
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?
As above.
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?
Not only do I think, as a matter of principle, one should NOT market the same drug for the same indication as OTC as prescription .... but I also think that it is not enforceable.
That is, if there is any question whatsoever of the safety of a drug in minors ... it would be extremely difficult to limit access of an OTC product as a practical matter.
B. If it could, would it be able to do so as practical matter and, if so, how?
As above ... I think that it is a practical matter more than a matter of law.
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 think this is precisely the practical problem of the legal proposal.
It should not be legal to market the same drug for the same indication as both OTC and by prescription, because it is impractical, potentially unsafe
.. and without proven benefit to curtail surgical abortions.
For these reasons, there is no ethical justification for it.