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 : EC594
Submitter : Mrs. Vicki Charocopos Date & Time: 10/12/2005 06:10:53
Organization : Mrs. Vicki Charocopos
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, there is no way to keep someone from buying the OTC drug for someone else. It would put many young women at risk.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
There is no confusion. When a drug is being used for identical purposes it should be consistent as far as prescription/OTC status. There would be no way to regulate who was actually taking the drug which would be very dangerous.
C. If so, would a rulemaking on this issue help dispet that confusion?
A rulemaking would only help to dispel confusion if there was a way to regulate who is buying and who is taking the drug. There is no way to ensure that someone isn't buying the drug for someone under the age of 16 or someone who could have severe side effects from using the drug.
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 just as there is no way to stop adults from purchasing alcohol for minors there would be no way to prohibit someone from buying the Plan B drug for someone age 16. To think that this would be possible is absolutely ridiculous. Many young women's lives would be put in jeopardy.
B. If it could, would it be able to do so as practical matter and, if so, how?
No - it would not be practical to make Plan B OTC. It would put women's health in jeopardy.