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 : EC1108
Submitter : Mr. Darrell Tangman Date & Time: 10/27/2005 02:10:44
Organization : Mr. Darrell Tangman
Category : Individual Consumer
Issue Areas/Comments
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?
No comment.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No comment.
C. If so, would a rulemaking on this issue help dispet that confusion?
No comment.
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?
Similar restrictions on availability of alcohol and tobacco on the basis of age encounter no legal difficulties. There appears to be no impediment to FDA enforcement of such a rule.
B. If it could, would it be able to do so as practical matter and, if so, how?
As a practical matter, DEA use of armed violence has been unable to eliminate availability of illegal drugs, so probably not.
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 comment.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Prescription-only drugs are often supplied to the consumer in packaging that provides little information on side effects and counter-indications, with the required information provided in literature supplied at the point of sale. This would be inappropriate for OTC sale.
The use of irrelevant rule-making questions to delay or block approval of OTC emergency contraception is seriously compromising FDA's ability to command respect. At one time it was widely believed that the FDA existed to protect consumers from medical fraud, by ensuring that drugs and medical appliances are accurately labelled and that decisions on their availability are based on scientifically valid evidence. The FDA is coming to be seen as a political, rather than a scientific, organization, and it is past time for that to come to an end.