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 : EC889
Submitter : Mrs. Patrice Egging Date & Time: 10/17/2005 11:10:24
Organization : ABC Pregnancy Help Center
Category : Other Organization
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. If a drug has been marketed as a prescription, it should continue to be marketed as a prescription, unless it is deemed safe for ALL and under all circumstances. With the drug in question, the morning after pill, the girl or woman, should be under the care of a doctor. OTC sales would not be able to limit who uses this drug.
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. Either a drug is prescription or it is OTC.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Has there been confusion over other drugs? Or is it just this one, the morning after pill. If the confusion is because someone wants girls to have access to this pill, I would urge you to consider abuses that will occur that will never be reported because a pill was taken to cover up tracks. Pregnancy rates will not go down, and neither will abortion rates or STD infections. Women will just be hurt even more than they are now.
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?
Absolutely not.
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?
No. What would be the purpose in doing this?