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 : EC1309
Submitter : Ms. Patricia Parris Date & Time: 10/28/2005 03:10:19
Organization : Ms. Patricia Parris
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?
The FDA should approve IMMEDIATELY over-the-counter sale of emergency contraception with NO prescriptions required for any age group. This would obviate the need for any future rule making/legislation. Two advisory FDA committees exhaustigely reviewed data in 12/03 and found that EC is safe and effective and then recommended over-the-counter approval. More than 70 medical & public health associations including the AMA, American College of OB/GYNs and the Society for Adolescent Medicine have already 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 acess to contraception, including barrier methods and EC supplies."

The apparent move by the FDA to restrict access to young women, 16 years of age and younger, therefore flies in the face of the recommendations of the majority of respected medical professional associations AND the goverment's own stated policy.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No -- The FDA's apparent intent to limit access according to age has muddled what should have been a clear-cut decision to approve over-the- counter sale of EC.
C. If so, would a rulemaking on this issue help dispet that confusion?
A proposed rule with a the lengthy comment and review process has only been suggested to further drag out the time period before a final decision on over-the-counter access to EC is made. Completely and utterly UNNECESSARY!!!!!
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?
We all know about things which are sold only to purchasers over a certain age, i.e., cigarettes, alcohol, etc. However, asking for i.d. is an unacceptable intrusion into a young woman's privacy with regard to her medical care with regard to an item such as EC. Limiting the sale of EC
to young women is a BAD idea, and it is inappropriate to deny young women the means, any means, to prevent an unwanted pregnancy, in my opinion. The job of the FDA is to determine the safety and efficacy of a drug, period ---- NOT to be the morality police or Big Brother.
B. If it could, would it be able to do so as practical matter and, if so, how?
I don't EVEN want to go there in my own mind -- it REEKS of "1984". It is too scary to contemplate.
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?
All the FDA has to do is make EC available to every woman, everywhere, of every age, PERIOD. This obviates the need for separate packages. End of problem.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
There are no circumstances where under which it would be inappropriate for a single package to be sold.
Nearly 40 other countries have EC without prescriptions. It is just unbelievable to me that the USA still doesn't!! It is ridiculous that American women still don't have access to EC over-the-counter. Please quit the delaying tactics, quit insulting us, quit discrediting yourselves, GIVE US EMERGENCY CONTRACEPTION.