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 : EC2201
Submitter : Dr. James Hasselle Date & Time: 10/31/2005 06:10:04
Organization : Dr. James Hasselle
Category : Drug Association
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?
More than 70 professional medical and public health associations including the American Medical Association, the American College of Obstetricians and Gynecologists and the Society for Adolescent Medicine have endorsed EC access for women of all ages. The American Academy of Pediatrics has urged its members to "help ensure that all adolescents have knowledge of and access to contraception, including barrier methods and EC supplies.


1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The Food and Drug Administration's apparent intent to limit access by age has muddled what should have been a clear- cut decision to approve over-the-counter sale of this safe and effective emergency contraception.


C. If so, would a rulemaking on this issue help dispet that confusion?
Yes
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?
Already done in other areas. Same as sail of cigarettes and alcohol.
Simply ask for ID.
B. If it could, would it be able to do so as practical matter and, if so, how?
Ask for ID.
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, No reason not to.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
See none. Special cautions as to age, for example could be on insert in OTC package.
GENERAL
GENERAL
In my opinion benefits more than outweigh anxieties and concerns.