2005N-0345
FDA Comment Number : EC1539
Submitter : Mr. Daniel Noel Date & Time: 10/31/2005 09:10:43
Organization : Mr. Daniel Noel
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?
The FDA needs to put science over religion and avoid throwing bureaucratic obstacles in the path to reasonable decisions just to satisfy some religious bias with no scientific foundation. OTC availability of emergency contraception is a very positive public health improvement for women, especially those who are sexually ignorant, such as the young, the poor and the religious fundamentalist.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Of course. The FDA is putting forward the silly argument of an age threshold for emergency contraception, as if it were able to regulate an age threshold for sex. This is religious idolatry disguised as medicine.
C. If so, would a rulemaking on this issue help dispet that confusion?
What is needed here is a complete and unconditional retreat from the silly argument of age threshold for emergency contraception. The concept of rulemaking is the subversion of bureaucracy to further an extremist religious agenda that has nothing to do with the FDA's mission, which is public health. Just as fundamentalist preachers wolud not accept an AMA representative at their pulpits, the FDA ought to repel any influence that bears no actual medical legitimacy.
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?
The FDA's mission is to promote public health, not to follow a narrow religious agenda. Restrictions that protect public health , such as on tobacco and other drugs should they become legal, make much sense. But restricting emergency contraception's OTC sales to adults is ridiculous. If a preacher wants his teenagers to stay pregnant following a rape, let him exhort her flock to do so. If my daughter has sex and does not want me to be aware of it through a potential pregnancy, her safest option is to seek emergency contraception, and the FDA's duty, by God, is to allow her access to it.
B. If it could, would it be able to do so as practical matter and, if so, how?
All methods that can be imagined need to invade some privacy and possibly delay the purchase. The FDA needs to be guided by the interest of public health. This questionnaire makes me think that the FDA is about to regulate a newly-decriminalized marijuana market. Obviously, OTC narcotics availability ought to be restricted to adults with special permits, typically obtained through a detox program. Now, the concept of asking
pointed question to my 14-year-old daughter asking for emergency contraception is outrageous.
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 a question for the FDA, law enforcement experts, and the medical industry to sort out. My only advice is that the FDA is bureaucratic enough as it is.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
This is a question for the FDA, law enforcement experts, and the medical industry to sort out. My only advice is that the FDA is bureaucratic enough as it is.
GENERAL
GENERAL
Through its artifical bureaucratic delays in the approval of emergency contraception on an OTC basis is an insult to medical knowledge, the FDA is needlessly keeping at risk the health of millions of women, particularly fundamentalist teens, is slapping in the face the medical community, and makes the USA the laughingstock of the Western industrialized democracies.
The FDA's zeal in rushing to approval medications known to be dangerous shows no sign of abating. This also shows a callous disregard for public health.
I have called in the past for the dismantlement of the FDA and its replacement by a private non-profit outfit modeled after UL. I look like an extremist, but the FDA, should it keep on with the same policies that blatantly disregard the public interest, feeds the realism of my idea.