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 : EC368
Submitter : Ms. Juanita Allen Date & Time: 09/20/2005 04:09:10
Organization : University of Utah College of Nursing
Category : Drug Industry
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?
As a medical professional I strongly oppose the FDA modifying section 503(b) to allow the morning after pill to be put on the counter to be used by anyone. It is irresponsible and could also be deadly. Please leave this drug in the hands of the trained professionals to dispense it wisely.
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?
Definately not, how could and would you? Wouldn't the cost far outweigh what some seem to be a benefit of this OTC drug. Are you not opening up a great can of worms for lawsuits against the FDA? There is great danger in allowing this type of drug to be use by anyone after their sexual experiences, would they delay the need for STD evaluations, would they wait too long and have further complications?
Please do not allow this drug to be used OTC. It is not wise direction from the FDA, the risks and possible deaths far outweigh anything good that could come from it. Thank you.