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 : EC860
Submitter : Ms. Sara Oberst Date & Time: 10/17/2005 10:10:09
Organization : Ms. Sara Oberst
Category : Individual Consumer
Issue Areas/Comments
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?
Yes, the FDA should be able to sanction pharmacists or pharmacies that are not in compliance.
B. If it could, would it be able to do so as practical matter and, if so, how?
It should be able to take complaints and/or perform random visits to pharmacies. Any found to be acting illegally should be warned with an ultimate penalty of a fine and/or suspension of license.
3
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?
Yes, as long as the appropriate warning is on the outside of the package.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
If the drug caused a severe reaction in one subgroup of the population. By severe I mean death or permanent damage to one's health.
GENERAL
GENERAL
Everyone agrees that unplanned pregnancy is a problem in this country. This includes teens, women who've been raped and those whose contraceptive methods fail. As a matter of public health, it is imperative that women have the ability to easily access emergency contraception. By providing this option the number of abortions performed in the US, which has remained steady at about 1.5 million for 15+ years, would decrease; there would be less women and children living in poverty; and rape victims would more easily recover from their assaults. In the case of EC the FDA MUST listen to the scientific evidence. Any other decision would greatly diminish the integrity of the association.

Although I believe that all subgroups should have access to OTC EC, any improvement over the status quo would be welcomed. Perhaps few prescription drugs are treated in this manner, but there are many other examples of assigning age restrictions on substances. Of course with tobacco,
for instance, some adolescents under the age of 18 will end up purchasing a pack of cigarettes, but this is a small minority. And because no woman truly wants to use EC it is unlikely that any age restrictions would be broken.