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 : EC788
Submitter : Dr. Thomas Phlips Date & Time: 10/13/2005 08:10:01
Organization : Dr. Thomas Phlips
Category : Health Professional
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?
Not in the case of Plan B.
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?
No.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes.
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?
Probably.
B. If it could, would it be able to do so as practical matter and, if so, how?
Very difficultly.
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?
This is an absurd question: after some time people will know the way (ex. a friend or relative with the required age of 17 years) how they can buy it OTC and the different package for prescription will be of no use.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Any.
GENERAL
GENERAL
One of the main arguments for providing an OTC version of Plan B and similar products is a presumed reduction in the number of needed pregnancy terminations of unwanted pregnancies. Similar products have been approved for OTC use in several countries in Europe (Great Britain, Belgium, France,...), many times with this same argument of reducing the absolute number of pregnancy terminations. In september 2000 Norlevo was introduced as an OTC product on the Belgian market. Now on a total population of 10 million persons more than 1OO.OOO units are used each year. The number of pregnancy terminations has increased significantly since then: 14923 in 2000, 16707 in 2003 (an increase of 21%). The number of OAC remained stable in that period and there was a major increase in pregnancy terminations in the 12-20year age group. Recent (unpublished, 2004-2005) numbers indicate an even higher increase. The same trend has been seen in Great Britain.

Is it possible to publish (or email) the review of scientific studies on wich the Center for Drug Evaluation and Research or CDER, has based its conclusion that the available scientific data are sufficient to support the safe use of Plan B as an over the counter product?
And what fysiologic argument is given to withhold it to women 16 years old and not to women who are 17 years and older?
Are there any large scale studies on the metabolic and cancerogenic long-term efects of these products included in this review?
In recent years there has been seen an increase in early (30-40years age group) and often very aggressive forms of breast cancer: have there been any studies undertaken to link the use of morning-after pills as one of the possible causes?

Thanks,

Thomas Phlips, MD