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This blog is the work of an educated civilian, not of an expert in the fields discussed.

Saturday, August 26, 2006

Plan B

And Also: The NYT article provides a money quote: "The agency has regulatory authority over a quarter of the United States economy. Despite this huge portfolio, three commissioners devoted countless hours to considering whether to switch Plan B. a small-selling, decades-old medicine, to over-the-counter status." I wonder: should this politicizing of women's health really be deemed legit? As the article notes studies suggest, it will be no panacea, just one useful way to further women's health, and yes, stop some unwanted pregnancies and abortions. See below for a lot of chatter on the matter.


Let's go back over this torturous history. In 2003, the FDA's scientific advisers overwhelmingly recommended Plan B as safe and effective enough to be sold over the counter without any age restriction. It was described as "safer than aspirin.'' The right wing promptly went ballistic and tried to cast Plan B as an abortion pill. When that failed scientific muster--emergency contraception does nothing if you're pregnant--the same groups got behind the push for escalating age restrictions.

First, a cowed and politicized FDA told the manufacturer to reapply, restricting the pills to 16 and over. Then, more than a year later, one acting FDA commissioner upped the age up to 17. Now the newest acting FDA commissioner, Andrew von Eschenbach, has pushed the age up to 18.


-- Ellen Goodman

I noted yesterday that the FDA acceptance of over the counter use of Plan B contraceptives was 3/4 of a good thing. The extended lag time leaves a bad taste, especially since it clearly was not medically mandated. In fact, a lawsuit is ongoing respecting this very fact. The FDA is not supposed to be the morality police. And, this is clearly the reason a 23-4 vote was put aside for so long. The dubious exception for minors adds to the 1/4 bad flavor. Finally, as discussed below, there is the questionable limit as to locale of sale.

Abortion politics affect contraception policy, including ill-advised "abstinence education," which a 60 Minutes report and a lot more have shown to be counterproductive. And, constitutionally dubious, including when involving publicly financed religious teaching. It is especially dubious because of Griswold v. Connecticut, which covers teens too per Carey v. Population Services International. Such rulings hold there is a constitutional right of privacy which involves use and purchase of contraceptives without being forced to deal with unreasonable regulations.

And, though Roe v. Wade reminds us that "contraception" is most likely best viewed as a process, overall this includes techniques that might work after fertilization overall.* Thus, IUDs were one type of contraceptives used and protected in the 1960s, even though it might involve blocking implantation of a fertilized egg. Plan B is even more hazy: it is not always clear exactly how it blocks pregnancy: it might stop fertilization or in some cases implantation. Thus, by a strict reading (if one that twists general understanding of the terms at hand) it might be deemed an "abortion pill." Abortion is legal though.

Plan B is often seen as an "emergency contraception," used when other means cannot be used or perhaps fail in some way. Thus, it is particularly used in cases of rape, but other scenarios can be imagined: broken condoms, misuse of other methods, or generally, sex without protection. In the real world, this happens a decent amount of time. Carey et. al. rejects a scenario in which "pregnancy and the birth of an unwanted child [or the physical and psychological dangers of an abortion] [is used] as punishment for fornication." [First bracket in original.]

They also doubted that bans would "substantially discourage early sexual behavior. Justice Stevens noted separately:
Common sense indicates that many young people will engage in sexual activity regardless of what the New York Legislature does; and further, that the incidence of venereal disease and premarital pregnancy is affected by the availability or unavailability of contraceptives. Although young persons theoretically may avoid those harms by practicing total abstention, inevitably many will not. ... In essence, therefore, the statute is defended as a form of propaganda, rather than a regulation of behavior. Although the State may properly perform a teaching function, it seems to me that an attempt to persuade by inflicting harm on the listener is an unacceptable means of conveying a message that is otherwise legitimate.

One might argue that the law here is not a total ban, but one that requires minors to have a prescription. But, Carey dealt with "nonprescription contraceptives" and noted that: "as applies to nonhazardous contraceptives, [the law] bears no relation to the State's interest in protecting health." Plan B is such a "nonprescription contraceptive" generally. The question then becomes if there is something special that justifies prescribing it to minors. The ruling was particularly concerned with arbitrary nature of doctor control while Justice Powell noted that many under eighteen are married or perhaps was given permission by their parents.

Also relevant is this statement: "Limiting the distribution of nonprescription contraceptives to licensed pharmacists clearly imposes a significant burden on the right of the individuals to use contraceptives if they choose to do so." The news story linked below notes: "Today, the U.S. Food and Drug Administration agreed to make Plan B available without a prescription, but only for women 18 and older and only behind the pharmacy counter." This would apply to adults. Why is a non-prescription time sensitive item like this restricted thusly?

The Supremes struck down the New York regulation at hand. Thus, I think there is a reasonable constitutional claim against this regulation. As noted, there is a lawsuit ongoing underlining that delays were not motivated by health concerns, which is the mandate of the FDA. Political motivated. It is not the Morality and Drugs Agency. Such litigation in part is likely to show the unreasonable nature of the limitation on minors, including those 16-17, and if anything more likely to need such drugs than many adults. The time lag in obtaining a prescription is especially troubling when you are dealing with a substance that must be taken within seventy-two hours, the quicker the better.

As Justice Stevens notes, the government cannot harm its citizens purely to send a message. This includes cases when the alleged reasons turn out to be fictional in reality. But, this bunch creates their own reality. This might be so, but they are not allowed to create their own constitutional universe. Darn if they try though.

Still, better late than never. No big props deserved for waiting so long to do what should be par for the course, but still it's a good thing overall. Nonetheless, as usual, it comes with problems. Par for the course these days.

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* A theme that still holds true; note also the mention of "morning after pills":
"...the Church who would recognize the existence of life from [p161] the moment of conception. [n61] The latter is now, of course, the official belief of the Catholic Church. As one brief amicus discloses, this is a view strongly held by many non-Catholics as well, and by many physicians. Substantial problems for precise definition of this view are posed, however, by new embryological data that purport to indicate that conception is a 'process' over time, rather than an event, and by new medical techniques such as menstrual extraction, the 'morning-after' pill, implantation of embryos, artificial insemination, and even artificial wombs."