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 : EC1939
Submitter : Ms. Kathy Horak Date & Time: 10/31/2005 04:10:09
Organization : Ms. Kathy Horak
Category : Individual Consumer
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?
The Food and Drug Administration should simply approve without further delay over-the-counter (OTC) sale of emergency contraception - with no prescriptions required for any age group. This obviates the need 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.

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


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?
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.


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?
As a matterof law, perhaps.
Practically speaking, no.
B. If it could, would it be able to do so as practical matter and, if so, how?
No. I raised a teen-age daughter, so I speak from experience.
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?
If it is the same active ingredient, how are there "different products?"
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.


GENERAL
GENERAL
As a member of the National Organization FOR Women, I believe that the requested public comment period is a delaying tactic by the FDA to avoid having to make a decision - a decision that might enrage the administration's extremist anti-birth control supporters if they allow EC to be sold without prescription to all women of childbearing age. POLLS SHOW THAT A MAJORITY OF THE PUBLIC SUPPORTS EMERGENCY CONTRACEPTION.

It's my body, not yours. Please keep off!