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 : EC1485
Submitter : Ms. Maggie Daly Date & Time: 10/28/2005 04:10:05
Organization : Ms. Maggie Daly
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. I do not understand why you are stalling so much on the over-the-counter(OTC) sale of emergency contraceptives. The 2 advisory FDA committees that reviewed the research data in December 2003 found that emergency contraception was safe and effective, and recommended it be approved for OTC. More than 70 professional medical and public health associations, including the AMA, have endorsed EC for women of all ages. The American Academy of Pediatrics has urged members to "help ensure that all adolescents have knowledge of and access to contraception, including barrier methods and EC supplies."

When the age restriction was suggested in December at the Advisory Committee meetings, the FDA staff noted that it has been the policy of the Division of Reproductive and Urologic Drug Products to make NO DISTINCTION between post-pubescent adolescents and adult women insofar as contraceptive use is concerned. They then rejected the age restriction proposal, so I don't understand what this delay is really about, if not for politics and religion, which should have NO PART in ANY FDA decision regarding our health and safety.

The FDA should simply APPROVE IT IMMEDIATELY. Keep RELIGION and POLITICS OUT OF OUR HEALTHCARE!!
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?
I don't know why this question is listed twice, but here is my answer again:

NO. I do not understand why you are stalling so much on the over-the-counter(OTC) sale of emergency contraceptives. The 2 advisory FDA committees that reviewed the research data in December 2003 found that emergency contraception was safe and effective, and recommended it be approved for OTC. More than 70 professional medical and public health associations, including the AMA, have endorsed EC for women of all ages. The American Academy of Pediatrics has urged members to "help ensure that all adolescents have knowledge of and access to contraception, including barrier methods and EC supplies."

When the age restriction was suggested in December at the Advisory Committee meetings, the FDA staff noted that it has been the policy of the Division of Reproductive and Urologic Drug Products to make NO DISTINCTION between post-pubescent adolescents and adult women insofar as contraceptive use is concerned. They then rejected the age restriction proposal, so I don't understand what this delay is really about, if not for politics and religion, which should have NO PART in ANY FDA decision regarding our health and safety.

The FDA should simply APPROVE IT IMMEDIATELY. Keep RELIGION and POLITICS OUT OF OUR HEALTHCARE!!
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
YES. The FDA's apparent intention to limit access by limiting age has confused what should have been an easy, clear-cut decision to approve this drug for sale of this SAFE and EFFECTIVE drug as an OTC drug.
C. If so, would a rulemaking on this issue help dispet that confusion?
NO - YOU are the ones confusing this issue. Your own Advisory Committees have approved this more than once, and have already stated that age is not a factor in the safety and effectiveness of emergency contraception.

The only thing that would happen if you made up a new rule on this issue is to unnecessarily delay and drag out this safe and effective drug from us again. It is COMPLETELY UNNECCESSARY!
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?
NO. In this case, time and again, EC has been proven safe and effective for all menstruating girls and women, and that would be completely discriminatory, and unconstitutional. There is absolutely no reason for separating the two, except that the Religious Right Zealots think it is 'morally wrong,' and they are not running the FDA (nor should they be!) Asking for identification and having to have a doctor prescribe something to a young woman is bursensome and unnecessary (it's not like they can get 'high' from taking it - it is a medically necessary drug). Limiting sale of EC to young women is simply inappropriate - we all deserve access to EC, regardless of age or religion. The FDA's job is to determine safety and effectiveness, NOT to be the 'morality police' on behalf of the Right Wingers. KEEP RELIGION OUT OF IT!!
B. If it could, would it be able to do so as practical matter and, if so, how?
NO it would not. Such a move would be intrusive for all young women who would be required to show identification as proof of age. The suggestion of federal enforcement is absurd - abortion is legal (and must remain that way), so obtaining an even easier way of eliminating an unwanted pregnancy just MAKES MORE SENSE. I don't understand the Religious Right's views - they are against abortion, and yet have a problem with teaching prevention or using protection so there will be more abortions. That's just ludicrous and hypocritical when this wonderful, safe EC method is available - and LEGAL.
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?
That is a really silly question. Why would you need to separately package something that is legal and available both as a prescription and OTC? They should just package it the same way, or not make it a prescription at all - it has been found safe and effective for OTC, so why bother with a prescription?
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
There would be none. And there should be none. Your own Advisory Committees have agreed that age makes no difference in the safety and effectiveness of this drug. It's not like it's an opiate and anyone but the people who really need it will want it - it's not like people can 'get high'
off of it or something....
GENERAL
GENERAL
The fact that you are even questioning any of the validity of your own research and scientists suggests that there are other factors at work here, and we all know it's the conservative Bush administration and his conservative right-wing religious zealots that are to blame. PLEASE STOP POLITICIZING WOMEN'S HEALTHCARE. 95% of child-bearing-age women use contraceptives of some sort, which should go to show you that women want their contraceptives, and this is no different. Think of how many women would have been able to avoid an abortion if they had this drug available to them after an 'accident.' These things happen, people have sex and accidentally get pregnant, and the Religious Right and Bush and his buddies need to know that we are not going to put up with religion in our lawmaking or administrative decisions anymore. You must, as a matter of law and our constitutional rights, approve EC for OTC sale to all women immediately. Thank you.