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 : EC644
Submitter : Mrs. Lucille Mattair Date & Time: 10/12/2005 06:10:21
Organization : Mrs. Lucille Mattair
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?
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
C. If so, would a rulemaking on this issue help dispet that confusion?
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. I do not feel that some prescriptions should be allowed to sell OTC due to the fact that any one could purchase them and distribute them to the subpopulation that the prescription was not intended to be given to without a prescription.
B. If it could, would it be able to do so as practical matter and, if so, how?
I agree with allowing such things as cold, sinus, allergy and yeast infection meds to be sold OTC...but caution needs to be shown with anything else.
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?
I believe that OTC should be marked as such on the package.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
in all circumstances.
Getting OTC drugs to help with allergies, colds, etc., is not the same as the "morning after" pill that could be killing a fertilized egg. These are not germs...they would be a child. People need to start being held accountable for wrong choices and promiscuos lifestyles. Similar to the saying that "if you can't do the time, don't do the crime". I think the FDA needs to be very causious about what they sell OTC.