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 : EC1997
Submitter : Dr. Elana Lubit Date & Time: 10/31/2005 05:10:01
Organization : NYU School of Medicine
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?
NO. Rulemaking is unnecessary and could delay introduction of an important drug. If a drug has been established to be safe through multiple clinical trials, and meets the criteria for OTC marketing, it should be introduced. Rulemaking may be a political delaying tactic in such circumstances and must strictly be avoided.
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?
NO. Rulemaking is unnecessary and could delay introduction of an important drug. If a drug has been established to be safe through multiple clinical trials, and meets the criteria for OTC marketing, it should be introduced. Rulemaking may be a political delaying tactic in such circumstances and must strictly be avoided.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
NO.
C. If so, would a rulemaking on this issue help dispet that confusion?
NO.
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?
The FDA should not attempt to limit the sale of an OTC product to any subpopulation, unless this limitation is justified on MEDICAL grounds. The FDA must not attempt to control who may use the medication on any grounds other than health and safety. The prospect of the FDA attempting to set such limits, if not clearly indicated by medical study results, is a frightening subversion of medical authority for what could only be political purposes. As a physician I say this must not be allowed.
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?
It should not be legal to do this if it is not medically indicated, period.
GENERAL
GENERAL
The FDA must not attempt to limit the sale of an OTC product to any subpopulation, unless this limitation is justified on MEDICAL grounds. The prospect of the FDA attempting to set such limits, if not clearly indicated by medical study results, is a frightening subversion of medical authority for what could only be political purposes. As a physician I say this must not be allowed.