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 : EC870
Submitter : Mr. Luke Vander Bleek, RPh Date & Time: 10/17/2005 10:10:30
Organization : Fitzgerald Pharmacy
Category : Health Professional
Issue Areas/Comments
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?
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?
If FDA were able to allow these products for sale only in establishments already under FDA jurisdiction e.g. pharmacies, medical clinics, enforcement would seem plausible. However, if FDA allowed the marketing of this class of products by retailers not currently bound by FDA regulation, e.g. mass marketers, enforcement would be tenuous.
B. If it could, would it be able to do so as practical matter and, if so, how?
Practicality would be dependent on the structure of the business entity allowed to offer these items for sale.
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?
A prescription product would assume the patient has had the benefit of a medical examination and consultation of a willing physician and pharmacist.

An OTC product which could be acquired in a self service environment would necessarily carry the responsibility to inform the patient of proper use, mechanism of action, and the dangers of not submitting themselves to routine medical examinations to detect diseases. In the case of emergency contraceptive marketing, and despite the most comprehensive labeling, I believe that many young sexually active women will not recognize the value of routine gynecologic exams. These women will likely never submit themselves to routine gynecologic exams and public health will suffer.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Two products could be packaged in a single package techniqe, only when a substantial review of the impact of marketing the product over the counter would reveal that all other public health issues would either improve of remain unchanged.
Over the counter status of any drug should require research to assure that public health will be improved or at a minimum, not jeopardized by the OTC status.

In my experience as a community pharmacist, many women submit
themselves to a gynecologic exam only when necessary to receive a
contraceptive prescription. Since many diseases and other health conditions are discovered and consequently treated pursuant to routine exams, I believe public health will suffer from the otc status of emergency contraceptives, regardless of age requirements.