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 : EC761
Submitter : Dr. Gary Fitsimmons Date & Time: 10/13/2005 08:10:51
Organization : Dr. Gary Fitsimmons
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?
Yes, the element of subjectivity in these cases has become such that it no longer alows for a satisfactory resolution of the dilema. rguments should be made for or against the current interpretation and a decision should be made to allow or disallow it.
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.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes, by relaxing it's interpretation in the 1980s the FDA has opened the door to many further requests to relax restrictions on a host of other basis. These requests can now be made legitimately only because of the earlier decision to relax restrictions based on intended use.
C. If so, would a rulemaking on this issue help dispet that confusion?
Yes.
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?
No. There is currently no mechanism for such enforcement, not to mention the fact that enforcement of other such restrictions on products such as tobacco and adult magazines and videos have proven to be ineffective in keeping these products out of the hands of the subpopulations for whom they are considered inappropriate. Prescriptions are not 100% effective, but they are much more effective than any conceivable method of oversight. They are also already in place and would not add any new burden of enforcement to retailers.
B. If it could, would it be able to do so as practical matter and, if so, how?
It couldn't.
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. There would be no way for parents or guardians to tell if the product had been obtained by their children under 17 years of age by a legal perscription that they had not been made privy to or by illegally circumventing restrictions. The remedies which they could seek in such cases would be entirely different, depending on the circumstances.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
It would be inappropriate to do so under any circumstances.
GENERAL
GENERAL
The relaxation of restrictions on drugs that have previously required perscriptions always has the effect of taking the decision-making ability on what is good for public health out of the hands of medical professionals who have had years of training and are subject to extensive review and oversight and placing it into the hands of drug marketing companies whose motives must of necessity be those of financial gain with little oversight or restriction. This is not a wise course to follow.