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 : EC1606
Submitter : Miss. Heaven Hodges Date & Time: 10/31/2005 01:10:41
Organization : Miss. Heaven Hodges
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 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.

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.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
This relatively simple issue is being clouded by the FDA for god-knows-what agenda. The only confusion surrounding this issue has been manufactured by the FDA, mainly by this unnecessary public survey, which implies that public opinion trumphs the health of women and girls. There is no other confusion.

C. If so, would a rulemaking on this issue help dispet that confusion?
The only rulemaking that is necessary is the decision to make this product available to women and girls of all ages, without outside consent of any
person whatsoever, over the counter. Please spare Americans the unnecessary frustration of bureacratic delay. Indeed, such delays will function only to increase any confusion, as they will imply that there are as yet unconsidered aspects to this matter, which is, of course, false.
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 question of enforceability is a question of the FDA's reach, and one this organization should have it's own answer to. The real question in this matter, which, as is made obvious in the wording of these questions, you are trying to duck, and befuddle the public on, is whether this product should be sold OTC or not. The FDA's job is to protect the health of the public. That end would be served by the decision to sell this product OTC, so stop shirking your responsibility to the American people and do your job.
B. If it could, would it be able to do so as practical matter and, if so, how?
Such a limitation would be harmful to women's health, and a shameful disregard of the reproductive rights of women. The denial of natural rights can never be successfully regulated, because the oppresed will inevitably rise up and disobey the harmful edicts. This question of regulation and enforcement ignores the fact that the health of human beings is at stake, and is therefore inane.
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?
It is absurd to sell both a prescription and a nonprescription product together if they have the same active ingredient. This question is ludicrous, especially coming from a professional organization.
Please stand up for women's independence and reproductive rights, and stop delaying this crucial decision. Please remember that, by virtue of the position of everyone in the FDA, you are indebted to the American people; you are responsible for ensuring it's health to the best of your ability. Please remember that any and all ideological/political arguments against the complete and universal availability of this product are not admissible in your deliberations. Your sole concern is our health. Please remember that teens and adolescents are people, too; they have as much of a right to their own bodies as any adult. Recognize that it is arrogant, paternalistic, and ludicrous to deny a young woman contraceptive products on the basis of her age or parental dependence since she is mature enough to engage in sexual activity and become pregnant. Please do no punish young women who try to be reproductively responsible by denying them the means to do so. Please do not ignore the fact the not all parents act in the best interests of their children by putting their access to this contraceptive product at the mercy of parents. Please do no exclude young people from those to whom this product becomes available.