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 : EC2056
Submitter : Ms. Pat Malcolm Date & Time: 10/31/2005 05:10:15
Organization : Ms. Pat Malcolm
Category : Individual Consumer
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?
Maybe, but not at this moment. Please don't tie internal housekeeping to the release of emergency contraceptives for OTC use.
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?
Not right now. Don't tie this issue to the precedented release of emergency contraceptives for OTC use.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No, I think it's clear that the FDA is using this as a tactic for pacifying the fundamentalist Christian right-wing and avoiding its responsibility to provide timely release of safe, necessary birth control medications.
C. If so, would a rulemaking on this issue help dispet that confusion?
Not at all. Attempts at rulemaking in this instance sound like building a mountain of paper to hide behind when making a political decision in the guise of a responsible medical one.
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?
Of course. There are other OTC products limited in this way already.
B. If it could, would it be able to do so as practical matter and, if so, how?
Gee, no one has had much of a problem limiting access to Claritin-D and other pseudophedrin-bearing medications while still making them available OTC. Put shelf cards where the packages would be and have the public pick up the medication at the counter.
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?
Why not? We should do more of this so people can get insurance coverage for needed medications like Claritin-D and Zantac.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Only if they are not the same product.
GENERAL
GENERAL
Come on, you're dragging your feet and inventing issues to disguise the fact...but you're fooling no one. Meanwhile those who have a legitimate need for this vital medication are being done a disservice. Birth control is a necessary adjunct to providing responsible health care to women. Emergency contraceptives are an important improvement and vital in cases of rape, incest, failure of other methods, and the like. In this sense it is an important preventive to abortion, for crying out loud! It is no secret the Christian fundamentalist right-wing is opposed to this medication, but it is also no secret that the same faction is stridently opposed to birth control in almost any form. Don't let the current political climate deter you from your duty to responsibly serve Americans in protecting against unsafe or ineffective medications and in making safe, effective medications available in a timely manner. Approve OTC emergency contraceptives now!