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 : EC2075
Submitter : Ms. Rebecca Schaffer Date & Time: 10/31/2005 06:10:18
Organization : Ms. Rebecca Schaffer
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 FDA should approve the sale of OTC emergency contraception without further delay. No prescriptions should be required for any age group. New rulemaking is not required. Emergency contraception has been found safe and effective, and consumers know it.

The AMA and more than 70 other professional medical and public health associations have endorsed EC access for women of all ages. There should be no age restrictions on this drug.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The FDA's apparent intent to limit access by age has muddled what should have been a clear-cut decision to approve OTC sale of this safe and effective emergency contraception.
C. If so, would a rulemaking on this issue help dispet that confusion?
A proposed rulemaking 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?
Asking for identification is both burdensome and unnecessary - and is an unacceptable intrusion on personal privacy with regard to medical care. Limiting sale of emergency contraception to young women is a bad idea, and it is simply inappropriate to deny young women the 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?
Such a move would be intrusive for all young women who would be required to show personal identification as a proof of age. The suggestion of federal enforcement brings to mind federal agents pursuing 16 year olds concerned about an unintended pregnancy who in the act of obtaining
emergency contraception are breaking a federal law. The absurdity is hard to exaggerate.
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?
There would not be any circumstances that would be inappropriate for a single package.
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
Delaying this decision to approve universal, OTC availability of emergency contraception is an insult to all women. It discredits the FDA as a responsible, professional science-based organization. The proposal to restrict access of EC - OTC to women 16 and under makes no rational or practical or medical scientific sense. Determination of the safety and effectiveness of emergency contraception, with the added public health value of preventing unintended pregnancies - no matter the age of the woman - should be primary criteria for making this decision.

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.