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 : EC1619
Submitter : Ms. Mary Alice Belov Date & Time: 10/31/2005 01:10:35
Organization : Ms. Mary Alice Belov
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?
October 24, 2005

The FDA should simply approve without further delay, OTC sale of emergency contraception - with no prescriptions required for any age group. This obviates the need for any new rulemaking. Both of the 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.

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 and the government's own stated policy.



1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
There is no confusion regarding the FDA's interpretation of section 503(b) of the act.

The FDA's muddling of the situation is a false "confusion" and 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?
There is no confusion. There is only 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?
Such items that are sold only to purchasers over a certain age, includ alcohol, tobacco, and the nicotine patch. There is no point for such a limited sale. 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?
Again, this is totally impractical and there is no reason for such a move.

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?
Why not? They are the same product and have the same basic purpose - elimination of unwanted pregnancies.

Some with the anti-birth control ideology also pretend to wish to prevent abortions, but in fact, do what they can to cause unwanted pregnancies and, thus, abortions.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
I can think of no such circumstances.
GENERAL
GENERAL
This entire endeavor is an attempt to play to the few people with an ideology against birth control, a pretension for "pro-life," etc.

There is no true reason for this attempt to negatively affect women's lives - at any age.