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 : EC1044
Submitter : Ms. Trisha Pruis Date & Time: 10/27/2005 10:10:31
Organization : Ms. Trisha Pruis
Category : Individual Consumer
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?
In regards to Emergency Contraception, I think having the same ingredients in birth control pills, which are prescription-only, and EC, which is up for release OTC, is that birth control pills are long term commitment, while EC is one time use. A person only needs to understand swallowing 1 or 2 pills at the correct time, not everyday.
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 think if a law were created, it would have to be enforced at the level of the pharmacy or doctor. In reference to Emergency Contraception, I don't think their should be sub-population restrictions.

B. If it could, would it be able to do so as practical matter and, if so, how?
If there were sub-population restrictions, I suppose people would have to ask for identification with the age on it before dispensing the product. The problem with that is that not everyone over 16 will necessarily have identification with their age on it. Many people don't get driver's licenses at 16 and would therefore not be likely to get an ID. This would create problems getting the procduct to people that need it. Additionally, doctors and pharmacists are not going to want to add an extra step to their work. Doctors in particular tend to be very busy. Overall, asking for identification would probably not be practical.
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?
In reference to Emergency Contraception, I don't see why this is an issue. It would not make sense to sell birth control pills and EC in the same package because EC is usually one or two pills and birth control pills are usually 21 or 28. A person wouldn't need something with 21 or 28 holes for 1 or 2 pills. I think the nature of the product themselves preclude the same packaging.
I think safety is a first priority for any drug released OTC. Emergency Contraceptives have been proven safe and effective for use over the counter. I think questions like how to package it are just details. If it's safe, it should be an easy matter to package it. In regards to EC, I personally think that there should not be an age restriction of 16 placed on it. Like it or not, people younger than 16 have sex and are raped, and they need unrestricted access to EC as well.