hanneblank (![[info]](http://p-stat.livejournal.com/img/userinfo.gif){kind=small} hanneblank) wrote,@ 2005-09-13 15:42:00 |
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Aux armes, citoyens.
Preaching to the choir time, folks. I do hope that those of you who read this who are USAian will take some sort of action... if not on your own behalf, on that of someone who isn't yet old enough to know how much this stuff matters.
http://www.scarleteen.com/blog/index.htm
So. Please, if reproductive freedoms matter to you (and they damn well should), please take a moment to write a letter to the FDA weighing in. If only to tell them why they have no business at all subjecting drug approval for ANY demographic to the weight of public opinion. Deputy Commissioner Lester Crawford's email is : deputy.commissioner@fda.gov or you can send snail mail to him at the Food and Drug Administration / 5600 Fishers Lane / Rockville, Maryland 20857
My letter is below. Feel free to borrow from it at will.
Preaching to the choir time, folks. I do hope that those of you who read this who are USAian will take some sort of action... if not on your own behalf, on that of someone who isn't yet old enough to know how much this stuff matters.
http://www.scarleteen.com/blog/index.htm
So. Please, if reproductive freedoms matter to you (and they damn well should), please take a moment to write a letter to the FDA weighing in. If only to tell them why they have no business at all subjecting drug approval for ANY demographic to the weight of public opinion. Deputy Commissioner Lester Crawford's email is : deputy.commissioner@fda.gov or you can send snail mail to him at the Food and Drug Administration / 5600 Fishers Lane / Rockville, Maryland 20857
My letter is below. Feel free to borrow from it at will.
Dear Dr. Crawford,
I am alarmed by the current "public comment" period in regard to the issue of over-the-counter Emergency Contraceptive pill access for young women.
Contraceptives access for all women, including unmarried women, has been constitutionally protected since Griswold v. Connecticut in 1965. Since then, the Pill and its hormonal contraceptive offshoots, such as Depo-Provera, Norplant, NuvaRing, Mirena, and so on, have proven to be popular, effective, and low-risk means for managing the risk of unplanned pregnancy for married and unmarried women alike, very much including the younger, unmarried women about whom the FDA claims to be so powerfully concerned.
I find it condescending in the extreme that the FDA feels that it is in any way realistic to claim that younger women should be barred from using EC / Plan B because they are incapable of following the dosage instructions properly. This is inaccurate, misogynist, and medically unfounded.
First, there is no research that proves this to be true. The assertion that this is true is a red herring. Former FDA Women's Health Director Susan Wood -- a name I presume you know -- has made it clear that these and other, similar contentions are untrue.
Second, there is no research available in the present medical literature (at least according to the reference librarians at the National Library of Medicine and the Johns Hopkins School of Medicine's Welch Library) proving a risk of real and pertinent harm to patients who do not follow EC dosage instructions and instead double-dose themselves by taking both doses simultaneously.
Third, women are not stupid, even young women. If we assume for the sake of argument that the teenaged daughters of America are generally capable of such complex tasks as driving automobiles, and doing sufficiently well on the SATs to be admitted to college, it follows without exception that they are likewise generally capable of comprehending and following a simple one-sentence instruction on a pharmaceutical product.
This "public comment" period -- which I will note has never been enacted for any other drug, like, say, Viagra -- is an obstruction of the FDA's purpose and a perversion of the FDA's well-established role as an agency existing to protect the public health. The FDA does not have a mandate to have its drug regulations reflect public opinion, only public health and safety. The FDA is not a representative body but a scientific and research body.
Public opinion is irrelevant to the job the FDA is mandated to perform. Empirically tested and reproducible medical data are not only relevant to the job the FDA is mandated to perform, they are the ESSENCE of the job the FDA is mandated to perform. Flatly put, if there are no data that show that a particular drug protocol has an undue risk to a particular demographic of potential drug users, then there is no reason that such a drug protocol should be made inaccessible to that demographic.
The FDA has a mandate to promote and protect the health and safety of all Americans, not to promulgate a patently false misogynist theory about female incompetence as a way of removing access to a perfectly valid, multiply-tested, effective contraceptive protocol.
Yours,
Hanne Blank
