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 : EC1631
Submitter : Ms. Hilary Spencer Date & Time: 10/31/2005 01:10:54
Organization : Ms. Hilary Spencer
Category : Academia
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?
There are many (active) ingredients currently shared between prescription and OTC drugs. There is no need to further postpone the decision to make EC available. Codification of an interpretation of 503(b) would delay the decision by an immeasurable amount of time by requiring debate over possibly thousands of products now available. The FDA 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.

1.
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 Food and Drug Administration has consistently muddled what should have been a clear- cut decision to approve OTC sale of EC.
C. If so, would a rulemaking on this issue help dispet that confusion?
No.
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?
The FDA's job is to determine safety and efficacy ONLY. We are all familiar with items that are sold only to purchasers over a certain age, including alcohol, tobacco, and the nicotine patch, however, the laws setting age limits were not made by the FDA.
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. 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?
If EC is universally available, then there is no need for separate packaging. However, I do not see the point of different packaging for products which contain the same (active) ingredients.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
None.
GENERAL
GENERAL
This latest tactic to further delay making the correct decision to approve universal, over-the-counter availability of emergency contraception discredits the FDA 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. The data indicate that access to emergency contraception will not encourage promiscuity or that EC would lessen the routine use of contraception-- contraception which is now available OTC.

The FDA's delay and ill-advised intention to restrict access to EC is unacceptable and intolerable. Please make the decision to allow emergency contraception available to all women, all ages, and without restrictions.