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 : EC746
Submitter : Mrs. Shawn Malarcher Date & Time: 10/13/2005 08:10:38
Organization : Mrs. Shawn Malarcher
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?
As I understand this issue, you already make this allowance with adult and child medicines which are both sold over the counter. There are also age restrictions on alcohol and cigarettes.
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 am extremely disappointed in the FDA. This agency is suppose to make decisions based on evidence. I feel this issues has been usurped by political agendas. There is no evidence that EC is harmful. As understand it, the reason the age limit even exisits is because there was an absence of evidence not that there was evidence that use would be harmful. Also, why was the age limit raised to 17? What was this decision based on?

Again, age limits are enforced on other products. If that is ultimately the decision of the panel, I don't see any difference in enforcing age restrictions on EC vs alcohol or beer.
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?
I don't see why not.
The decision on this issue has taken too long. It is time to come to conclusion. There is no evidence that this product is harmful unless taken in excess like any other OTC drug. Oral contraceptive are sold over the counter in most other countries in the world, developed and undeveloped. There is a great deal of confusion among the population about this drug and how it works. I believe a large part of that is due largely to the FDA approval process and internal inconsistencies.