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 : EC1862
Submitter : Dr. Benzi Kluger Date & Time: 10/31/2005 03:10:11
Organization : University of Florida
Category : Health Professional
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 approve without further delay OTC sale of emergency contraception. The scientific basis for this decision and the public health implications are undeniable. The medical community 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.

A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?
see above
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The FDA's intent to limit access by age is confusing and not particularly relevant.

C. If so, would a rulemaking on this issue help dispet that confusion?
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.
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?
It may be able to enforce it, at least to a degree. In general, these measures fail as can be seen with the degree of teenage alcohol and tobacco use.
B. If it could, would it be able to do so as practical matter and, if so, how?
It would be neither practical nor just. Unlike alcohol and tobacco, which are clearly harmful, EC would be beneficial to the lives of those young adults who use it. Teen sex will happen and is happening regardless of the OTC status of EC, but the availability may imact teen pregnancy.
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?
None that I can think of in this particular case.
It is time for the FDA to stop dragging its feet and finally take an action that will benefit millions of people (both men and women). While I appreciate the need for deliberation, the scientific and public health communities leave no doubt as to what the correct course of action is. Conservative politicians misunderstanding of what EC is (an abortion) and what it will lead to (increased unprotected extramarital sex) are uninformed and irrelevant and should have no bearing on the decisions made by an organization such as the FDA, whose purpose is to safeguard the American public and further public health.