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 : EC1701
Submitter : Mrs. Danna Mattocks Date & Time: 10/31/2005 02:10:10
Organization : Mrs. Danna Mattocks
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.

As a parent and scientist I am amazed at the disregard for both the advice of the FDA's own scientific experts and the wellbeing of women in the United States that is being demonstrated by your organization over this issue. If the FDA's decision's are going to be dictated by special interest groups or the Oval Office then I will fear to trust in the safety or efficacy of any drug approved. I would also question whether those deemed unsafe are indeed dangerous or perhaps just not approved by certain special interest groups. FDA must base decision's about drug safety and accessibility on the scientific merits of each application not current politics.
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. The only confusion I feel is in trying to understand why this decision is not being made based on prevailing scientfic opinion and is instead being dictated by special interests.

C. If so, would a rulemaking on this issue help dispet that confusion?
No, a rulemaking would only further delay access to this safe, effective and vitally needed treatment. It would also set a precedent for special interest influence over what should be a straight forward process based on the scientific recommendations of the majority of experts in the field.
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, 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. If the drug is safe for women capable of becoming pregnant then it shouldn't matter what age they are.

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. Would you prefer for your own young daughter, relative or friend to have to not only worry that she may become pregnant but also that she will be breaking the law if she tries to obtain the only safe remedy available? This is ridiculous, as anyone who is presently living in our country can attest limiting the age of cigarette purchase has not stopped any mildly determined minor from obtaining them and they are known to cause harm. There is just not any societal support for rigid enforcement of these laws.

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. What would be the point of eparate packaging so you would be able to tell if the person who bought it is over a cetain age? This question is just silly in my opinion.

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
There are no circumstances that I can think of where it would be inappropriate to use the same package.
This latest tactic to further delay making the correct decision to approve universal, over-the-counter availability of emergency contraception is an
insult to all women. It further discredits the Food and Drug Administration 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. What could possibly be the public health value in restricting access to adolescents ill- prepared ? emotionally and physically ? to carry a pregnancy to term? We agree and the data indicate that access to emergency contraception will not encourage promiscuity or that EC would lessen the routine use of contraception.

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.