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 : EC1126
Submitter : Dr. Kathleen Griffin Date & Time: 10/27/2005 02:10:46
Organization : American College Obstetrics & Gynecology Fellow
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?
The FDA should quit stalling, resurrect some respect for itself as an agency, instead of a joke, as most patients think of it, and immediately approve this drug for OTC use for all ages. It is not more dangerous in women younger than 17, although an unwanted pregnancy definitely has much greater risk and social and emotional sequelae for women ages 13 to 16!! What could the dangers be of using the OTC drug inappropriately? Addiction? Overdose? Fetal anomaly? No and no and no. So what exactly is the problem?
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No, we understand a stall tactic when we see one.

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?
I certainly hope not. And I certainly hope money would not be wasted on "Morning After Pill Police" checking ID at the check-out counters! We certainly wouldn't want any 16 year olds driving under the influence of emergency contraception!
B. If it could, would it be able to do so as practical matter and, if so, how?
Ummmm, let's see...how about this: When the 15 year old checks out at the register she has to answer a question: Were any nuclear weapons ever found in Iraq? If she answers no, then she is smart enough to figure out how to use plan B!
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?
Sounds reasonable to me. Because hopefully if we are ever lucky enough to have leadership in the FDA like we had with Dr. Grimes and Dr. Kessler, we will once again be using scientific data to guide our decisions! What a concept! Then the product will only be OTC, so you might as well make all the packaging the same to begin with.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
I see no reason that it would be inappropriate.

"Inappropriate" however, describes this unnecessary and ludicrous delay tactic!