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 : EC626
Submitter : Dr. Gerald Peer Date & Time: 10/12/2005 06:10:26
Organization : Gerald L. Peer, MD
Category : Health Professional
Issue Areas/Comments
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?
The FDA should clearly define its policy. Its previous position, that a substance cannot be both prescription and OTC for the same indication, is rational and defensible and should be codified.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Not in the past. Confusion is building due to special interest pressure.
C. If so, would a rulemaking on this issue help dispet that confusion?
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?
With difficulty. Such a ruling places pharmacists in the same role as alcohol dealers, cigarette sellers and pornography peddlers: limiting exposure of the young to influences that could "corrupt youth." Why else would an age limit be imposed? And why would FDA want to approve a drug that would "corrupt youth?"
B. If it could, would it be able to do so as practical matter and, if so, how?
Extension of law enforcement by FDA on the general population complicates its mission and enlarges the obtrusive arm of government into private lives.
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?
How you package this product makes little difference. Any attempt to sell the same product as OTC and prescription makes a mockery of the prescription process.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Plan B is a bad idea. It is, by design, a lethal drug. To make this available without prescription cheapens the entire public safety mission of the FDA.