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 : EC1582
Submitter : Ms. Terry O'Neill Date & Time: 10/31/2005 01:10:13
Organization : National Organization for Women
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?
There is no need for a new, time-consuming rulemaking procedure. The FDA should approve over-the-counter emergency contraception, for women and teenage girls of all ages, without further delay. This product is safe and effective. The FDA doesn't need new rulemaking to simply implement the recommendation of your 2 advisory committees.

Please don't let politics or partisanship interfere with your decisionmaking. Ideology is not science. The FDA's responsiblity to women and teenage girls is to approve products that have been shown to be safe and effective. Not only has EC been shown to be safe and effective, but also it is a matter of basic reproductive health for women and teenage girls. It is especially important to make EC easily available for victims of rape or incest. Why is the FDA withholding this from them?

The more the FDA delays, the more women and girls are needlessly harmed by not having ready access to this safe and effective product.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
If you are ideologically or politically inclined to keep a safe and effective product out of the hands of the women and teens who need it, you can create 'significant confusion' regarding anything.

But if you are inclined to do your job, you will approve over-the-counter sales of emergency contraception without age restrictions and without further delay.

There is nothing 'confusing' about the conclusion of 2 FDA advisory panels that emergency contraception is safe and effective and should be approved for over-the-counter sales.
C. If so, would a rulemaking on this issue help dispet that confusion?
A proposed rule with its lengthy comment and review process is being suggested only to drag out the time period before a final decision on EC - OTC is made. It is 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?
The subpopulation being targeted here is teenage girls -- and withholding this safe and effective product from them simply because they are in their teens is an unacceptable intrusion on personal privacy with regard to medical care.

No compelling governmental interest is served by withholding a safe and effective product from teenage girls -- there isn't even any rational basis for it. In fact, the only reason offered is the one touted by extremist, anti-birth-control ideologues -- i.e.,that making EC available to teens will encourage them to be sexually active. No study supports that silly claim, and at least one study specifically refutes it.

It is inappropriate -- indeed outrageous -- to deny young women a safe and effective means to prevent pregnancy. The FDA's job is to determine safety and efficacy, not to serve as the 'morality police' on behalf of any special interest group.

B. If it could, would it be able to do so as practical matter and, if so, how?
Shall we have federal agents rifling through the medicine cabinets of 16 year old girls? Shall we make all check-out clerks 'deputy morality cops' for the federal government, required to demand personal identification from young-looking women before they can buy EC over the counter? For what purpose, to stop a teenage girl from preventing an unintended pregnancy? What on earth are you people thinking?

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?
If the product is safe and effective, make it available OTC. No need for a different package. It's simple. No need for complications and drama.

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
The product is safe and effective, so it would never be inappropriate to make it available over the counter.

Some 39 nations have made emergency contraception available without prescription and 8 states in the U.S. have now adopted a process to streamline access of emergency contraception. The FDA's delay and ill-advised intention to restrict access to women 16 and younger is unacceptable and intolerable. Please make the decision to allow emergency contraception available to all women, all ages, and no restrictions.

Additionally, it should be available OVER the counter, not 'behing the counter' where we would have to beg for it from pharmacists pursuting their own religious / ideological agendas.