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 : EC1416
Submitter : Ms. Deborah Ellstrom Date & Time: 10/28/2005 03:10:23
Organization : Ms. Deborah Ellstrom
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?
Please approve without further delay the over-the-counter (OTC) sale of emergency contraception - with no prescriptions required for any age group. There is no reason for any new rulemaking. The two advisory FDA committees that exhaustively reviewed data in December 2003 found that emergency contraception was safe and effective and consequently recommended OTC approval. Why have advisory committees if the FDA disregards extensive testimony already produced?

THe AMA, the American College of Obstetricians and Gynecologists and many other medical organizations have already endorsed EC access for women of all ages. This preparation has proven time and time again to be safe as prescribed for women to use with minimal supervision.

Young women of high school and early college age are certainly capable of using more complex drug delivery systems independently that that necessary to use emergency contraceptions. Or do we--using similar logic--ban the use of inhalers for asthmatics, or insulin pumps for teenage diabetics?

The apparent move by the agency to restrict access to young women, 16 years of age and younger, therefore is discriminatory and unreasonable.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The FDA apparently intends to limit access by age, which runs counter to the recommendations and findings of both expert committees. The FDA should move quickly 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?
No. Any proposed rule would only extend the time period before a final decision on EC - OTC is made. The lengthy comment and review process is, at this point in the review process, completely 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?
Certainly, there exists regulation of sale of some substances--for example, beer or cigarettes--to purchasers under a certain age. These restrictions do not directly involve healthcare, and absolutely do not involve sale of medication that is designed to work effectively within a period of a few days. Sale of emergency contraception most certainly does.

Limiting sale of emergency contraception to young women is a bad idea. Further regulatory interference to deny young women the means to prevent pregnancy is simply inappropriate.

The FDA's job is to determine safety and efficacy; this has already been proven throughout the already completed review process.

B. If it could, would it be able to do so as practical matter and, if so, how?
It is inappropriate to do so.

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?
The marketers would not be rquired to use different packaging if emergency contraception were to become universally available.

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
THere would be no situation that would render packaging an issue if emergency contraception were to become available as over-the-counter for all age groups.
I have always considered the Food and Drug Administration to be a responsible, professional science-based organization. As a trained chemist, I have put my trust in the professionals involved in the review process at the FDA. I'm not so certain I can trust future FDA findings without a detailed examination of the proceedings behind the findings. <sigh>

This proposal--to restrict access to emergency contraception for women 16 and under--makes no rational or scientific sense.

The determination to restrict or ban emergency contraception to certain age groups or populations should only be based on data investigating the safety and effectiveness of emergency contraception, and not on religious or philosophical grounds.

Emergency contraception is currently available without prescription in many countries and in eight states in the U.S.

Please make the decision to allow emergency contraception