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 : EC905
Submitter : Dr. R. Don Gambrell, Jr. Date & Time: 10/18/2005 01:10:20
Organization : Reproductive Endocriniologists
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?
As a Reproductive Endocrinologist who has done considerable research in contraception and infertility, as well as treatment in a very active practce for infertility, I am very concerned about the approval of "Plan B" for all age groups of women, and especially in adolescents. Studies from England show when postcoital contraception was tried in England in college coeds, there was increased promiscuity
and too frequent use. Not only can OTC contraception increase promiscuity, postcoital contraception with a single pill or even two, does not offer the same protection from sexually transmitted diseases. I have treated many young women with damaged fallopian tubes and the conception rate remains quite low, even when very expensive in vitro fertilization is used. Repeated use of postcoital contraception is very disrupting to the pituitary-ovarian axis and may lead to permanent changes that are difficult to overcome.
Is OTC emergency contraception in the best interest of women, especially in teens (in light of the studies that show it does not reduce unintended pregnancy rates, or abortion rate.) It is associated with increased sexually transmitted diseases, which wouild mostly go undiagnosed and untreated, a huge factor in future infertility, and also associated with a tripled ectopic pregnancy rate. There is an insuffficient data base for girls ages 16 and under. What insurances could the FDA provide to keep thes OTC pills from such young and easily impressionable girls?
Since the FDA has concluded that the available scientific data are sufficient to support the safe use of Plan B as an OTC product, but only for women who are 17 years of age or older (with which I do not agree), and there is no conceivable way to prevent girls under age 17 from getting the drug for personal use. It is highly inappropiate for the FDA to make a new rule to accomodate Barr Laboratories requesrt for a double marketing standard (OTC and Rx, depending on age) for this identical product. We should not expose our young teens to a drug with unknown safety risks. I stongly recommend that Plan B remain available by prescription only so we practicing physicians can determine which of our patients should be allowed to use Postcoital contraception.
R. Don Gambrell, Jr., MD
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?
Certainly not when Plan B is involved.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Not confusion but inadequate scientific studies
C. If so, would a rulemaking on this issue help dispet that confusion?
The rules should not be changed for Plan B
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?
Irt would be very difficult if not impossble to enforce such a limitation. Boys or other people over the age of 17 could buy the pills and use them to entice youn impressionable girls to have sex.
B. If it could, would it be able to do so as practical matter and, if so, how?
I do not think the FDA could do so.
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?
Not advisable
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
This just should not be done for the multiple reasons stated above.