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 : EC1395
Submitter : Ms. Cathy Harris Date & Time: 10/28/2005 03:10:18
Organization : Ms. Cathy Harris
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?
The FDA should immediately approve OTC sales of emergency contraception with no prescriptions. Period. 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.

More than 70 professional medical and public health associations including the American Medical Association, the American College of Obstetricians and Gynecologists and the Society for Adolescent Medicine have endorsed EC access for women of all ages. The American Academy of Pediatrics has urged its members to "help ensure that all adolescents have knowledge of and access to contraception, including barrier methods and EC supplies."

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.
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 be a simple decision to approve OTC sales of this safe and effective emergency contraception.
C. If so, would a rulemaking on this issue help dispet that confusion?
A proposed rule is 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?
We are all familiar with items that are sold only to purchasers over a certain age, including alcohol, tobacco, and the nicotine patch. However 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. The FDA's job is to determine safety and efficacy, not to serve as "morality police".
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. This is absurd.
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?
Making EC universally available would obviate the need for separate packaging.

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.
This latest tactic to further delay making the correct decision to approve universal, over-the-counter availability of emergency contraception is insulting to all women. It further discredits the FDA as a responsible science-based organization. The proposal to restrict access of EC ? OTC to women 16 and under makes no practical or medical sense. The safety and effectiveness of emergency contraception, with the added value of preventing unintended pregnancies, should be primary criteria for this decision. There is no public health value in restricting access to adolescents - who are particularly ill-prepared to carry a pregnancy to term. We agree and the data indicate that access to emergency contraception will not encourage promiscuity or lessen the routine use of contraception.

Thirty nine countries have made emergency contraception available without prescription, and eight US states have adopted a process to streamline access to EC. The FDA's delay and intention to restrict access to women 16 and younger is unacceptable. Please make the decision to allow emergency contraception available to all women.