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 : EC110
Submitter : Dr. Carol Roye Date & Time: 09/20/2005 11:09:33
Organization : Hunter College
Category : Health Professional
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?
There is no reason to do this in the case of Plan B. There have been well-done studies that show that Plan B does not promote irresponsible sexual behavior by teenagers. In fact, several studies found that giving Plan B to sexually active teens at routine visits actually encourages more responsible condom use. I refer you to (among others):1) Raines T et al (2005, Jan. 5). Direct access to emergency contraception through pharmacies and effect on unintended pregnancy and STIs: A randomized clinical trial. JAMA, 293, 54-62; 2)Gold, M.A. et al. (2004). The effects of advance provision of emergency contraception on adolescent women's sexual and contraceptive behaviors. Journal of Pediatric and Adolescent Gynecology, 17, 87-96; 3)Roye C. & Johnsen, J. (2001). Routine provision of emergency contraception to teens and subsequent condom use: A preliminary study. Journal of Adolescent Health , 28, 165- 166.
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?
Not really relevant to a discussion of EC. This drug can safely be used by all women of childbearing age.
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?
It is difficult. Think about how many teens buy alcohol and cigarettes.