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 : EC789
Submitter : Ms. Trista Delamere Date & Time: 10/13/2005 08:10:33
Organization : Ms. Trista Delamere
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?
No. Or, if it does so, it should initiate this process AFTER making Plan B available OTC, and institute the rules later. Informing the company that the rules are forthcoming and that the marketing rules may change is sufficient.
STOP STALLING.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No. The only confusion is that which has been manufactured for political purposes in unethically stalling and limiting accessibility to Plan B.
C. If so, would a rulemaking on this issue help dispet that confusion?
You can argue about the color of the sky until the cows come home and the political cronies from the radical right will still claim it's red and it's causing the moral downfall of our nation. If the FDA chiefs want to clarify some rulemaking on this issue, go do it on your own time AFTER Plan B is made available OTC for the sake of women's health.
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?
That would put an undue and inappropriate burden on the FDA.
B. If it could, would it be able to do so as practical matter and, if so, how?
It would not be able to do so, in practical terms, no. If you want to require keeping the product in a locked case behind a counter (what, with the cases of cigarettes in grocery stores in some States?), the FDA would limit access simply thru intimidation, but how compliance with the "locked case" law is enforced State by State would be a complex issue.
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?
Yes. Creating an undue additional cost for the manufacturers by requiring different packaging will only drive up the price for consumers, thereby, in practical terms, limiting true and practical accessibility.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Under no circumstances-- the dosages listed would be the same, the directions the same, the product the same.
GENERAL
GENERAL
I am sickened by the politicizing of this issue and the continued lack of availability of this product when proper, recommended effective use requires accessibility to the drug on very short notice. The realities of healthcare today mean longer waits for doctor's appointments and fewer women with health insurance, even for minors. Requiring prescriptions or other limited access to Plan B for minors also means less privacy for young women.

Even this form, and the manner in which this 'open comment' subject is listed (with NO mention of 'Plan B', or contraception, or 'birth control' in the text whatsoever) indicates the head of the FDA is in no way interested in public comment as it relates to health and safety-- it's merely a way to further stall access to this drug, for political reasons.

Limiting access to contraceptives will in no way limit sexual activity between minors. Sex for unmarried females will not stop just because the GOP condems it. If the FDA is going to artificially make approval of Plan B into a 'moral' issue, then how about going further with prevention and making Viagra illegal? How about requiring temporary vasectomies for all 13 to 20 year old males? Or a penile chastity belt/cup? If you're going to be absurd, why not go all the way? Why not try to prevent the males from having sex? Why must all 'moral' policies in this area be overtly sexist and punish the female by creating overwhelming health, social and economic barriers to preventing and controlling pregnancy, when it obviously takes two to tango?

Clearly, the advisory committee did its job. I cannot blame any of the medical professionals who are quitting out of protest, though it distresses me to lose those valuable human resources who truly do come from a moral perspective.
What has my country become?