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 : EC1927
Submitter : Mrs. Kristin Moon Date & Time: 10/31/2005 04:10:05
Organization : Mrs. Kristin Moon
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?
Yes--often patients will abuse the OTC product--that is--to take it incorrectly and do themselves harm--even when the package is labeled for safe use. Other times, patients need doctor contact to rule out severe illnesses or needs, but having the medication available OTC keeps them out of the doctor's office
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
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?
If the drug is available AT ALL in OTC, the subpopulation will have a much easier time of getting the drug--and if they want it, they WILL find a method to get the drug. The FDA would have a very difficult time enforcing such a law. Better to leave the item in RX status.
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?
It should not be legal to sell the items in the same packaging--the average consumer would have too easy a time of calculating what was necessary for a prescription dosing of the drug.
I would strongly urge the FDA to not permit the OTC sale of the 'PLAN-B' type oral contraceptive--the so called morning after tablet. Women should be checked by their physician (i.e. need to get a prescription for this drug) so that:
1)Sexually transmitted disease can be detected
2) Statutory rape or sexual abuse can be guarded against