Wednesday, March 30, 2016

FDA Agrees That Womens' Abortion Choices/Rights Are Capable Of Local Physician-Assisted "Off-Label" Use: NYT

Other than to note that I think this intensely private decision ought to be -- and remain -- where the FDA today squarely agrees (once again) it is, and belongs -- i.e., in a quiet consultation between a woman and her own doctor, I won't delve into the politics of all the tangents radiating off of it. That said, I do agree with the FDA's stance here.

In all candor, today's FDA stance is simply a re-iteration of what practioners in this area of law have long known: so long as no drug company (or other biased influencing body) exhorts a doctor to write off label, any doctor may (consistent with her or his own beliefs about safe practices) use an approved drug -- any drug -- off label, after full and informed consent from the patient. Thus, except for the fact that today's announcement touches on an electoral hot-button drug -- there really isn't much news being made by the FDA here.

Do go read the full article, in the Gray Lady -- but here is a bit of it:

. . . .The move was a victory for abortion rights advocates who had been fighting laws in states like Texas, North Dakota and Ohio that required providers to follow the requirements on the original F.D.A. labels for the drug when conducting abortions by medication. Many doctors say the original labels, based on clinical evidence from the 1990s, were outdated and that the state laws requiring doctors to adhere to them went against accepted medical practice and made it harder for women to get abortions. . . .

In most states, doctors had been following the medically-accepted regimen, despite the fact that the label advised otherwise — a practice that is fairly common in medicine and is known as off-label use. But in recent years legislators in a number of states have sought to impose legal requirements that doctors follow the F.D.A. label for abortion medication, saying they were trying to protect womens’ health.

Such restrictions have passed but then been blocked by court order in Arkansas, Oklahoma and Arizona. Arizona legislators have passed yet another measure that tries to maintain the original F.D.A. protocol, but it has not yet been signed into law.

The F.D.A. first approved the drug, formerly known as RU-486, in 2000. It works by blocking receptors of progesterone, an important hormone in pregnancy. When taken with another drug, misoprostol, it induces miscarriage. It is different from the so-called morning after pill, which prevents pregnancy.

But the rules on the label were based on clinical trials completed in the late 1990s, according to advocates, and new evidence had emerged showing that taking lower doses was preferable and that a woman could take the medication safely up to 70 days from the beginning of her last menstrual period. . . .

This is, as ever, more of the modernizing of health care delivery, as envisioned by the Affordable Care Act of 2010. And I should note that this is not a Merck & Co. product, just to be clear. Onward, smiling now.

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