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 : EC849
Submitter : Mr. Michael Swarner Date & Time: 10/13/2005 10:10:26
Organization : Mr. Michael Swarner
Category : Health Professional
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?
I feel strongly that a drug should either be a prescription or an OTC, NOT both. I am tired of the games the brand manufactors are playing. Why do they not try for OTC status before their product's patent is about to expire? Different indications does not work and is getting abused. The best example has been the Prilosec nightmare. Thanks to the otc status, we now have people diagnosing and treating gerd and peptic ulcer disease. Many of them were forced by their rx insurance to purchase the otc product. Now they do not even follow up with their prescriber until serious symptoms exist.
Please take a stand that a drug is either prescription or OTC. Stop potential abuse that is occuring with OTC Prilosec. I have been practicing Pharmacy for 16 years.
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! Minors still obtain alcohol, cigarettes, and illegal drugs. A subpopulation will obtain Plan B also. I would like to quote Eve Espy, M.D. from an article in Drug Topics(June 20, 2005, page 14). "Every woman should have it in her medicine cabinet. I tell my patients that even if they don't need it, they can always give it to a girlfriend at her need." Enough said. And yes, I do dispense Plan B in my pharmacy.
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?
Absolutely not! As a Pharmacist, I cannot imagine how impossible it would be to not have total confusion over that idea.