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 : EC2161
Submitter : Ms. Jody Meisler Date & Time: 10/31/2005 06:10:36
Organization : Ms. Jody Meisler
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?
The FDA should approve over-the-counter (OTC) sale of emergency contraception without delay and with no limits on its availablilty. This obviates the need for any new rulemaking. Two advisory committees did their job and reviewed data finding in December 2003 that emergency contraception was safe and effective. They recommended OTC approval. Yet, FDA has stalled and ignored science, trying to deny women a viable option for contraception. THis is a personal medical decision. Why is the FDA playing the moral high ground?!

If more than 70 professional health associations can endorse EC access for women of all ages, how can the FDA justify doing anything but approving it.

When the age restriction was suggested at the December Advisory Committee meetings, the FDA staff noted then that it has been the policy of the Division of Reproductive and Urologic Drug Products to make no distinction between post-pubescent adolescents and adult women insofar as contraceptive use is concerned. The Advisory Committee members then rejected the age restriction proposal.

The apparent move by the agency 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, including the AAP and the government's own stated policy.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The FDA's obvious attempt to limit access by age is a tactic to limit use and should not be an issue in the 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?
A lengthy comment and review process is being suggested only to buy more time. It is completely unnecessary. A clear scientificly driven decision is already in hand. Approve it!

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?
Simply no. There is no "danger" in taking this other than a moral one. The government shouldn't be making medical and health decisions for others based on personal religious beliefs. That is the job of parents and clergy. Asking for identification is a ploy to embarrass girls so they won't ask for ER. This is infringing on personal privacy with regard to medical care, and I dare say gender discrimination, unless the FDA is prepared to ask for ID for condoms too.

Why must I feel compelled to repeat myself...The FDA's job is to determine safety and efficacy, not to serve as a moral compass for the nation on behalf of special interests.

B. If it could, would it be able to do so as practical matter and, if so, how?
No. The suggestion of federal enforcement is outrageous and doesn't deserve further discussion. The notion of doing so a practical matter is a rouse. You're not fooling me.

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. Making EC universally available would obviate the need for separate packaging.

Besides, has the FDA gone to such lengths for other products that have gone from presciption to OTC. I think not!

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 not be any circumstances that would be inappropriate for a single package. Your just looking for reasons to complicate a simple matter of meeting a consumer need with a product that some feel is against their religious groundings. To those of you to whom this relates, don't buy it.

It is time for the FDA to stop finding reasons to delay and correctly approve universal, over-the-counter availability of emergency contraception based purely on science.

The proposal to restrict access of EC ? OTC to women 16 and under serves no practical or medically scientific sense. Regardless of age, women should be able to make a purchasing decision just as a male would for a condom. The data indicate that access to emergency contraception will not encourage promiscuity or that EC would lessen the routine use of contraception.

Any more delay and ill-advised intention to restrict access to women 16 and younger is unacceptable and intolerable.

Please approve the availability of emergency contraception to all women, all ages, and no restrictions immediately.