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Thursday, Mar 31 2016

Full Issue

Abortion Pill Label Revised By FDA, Negating Anti-Abortion Efforts In Several States

The Food and Drug Administration updated the guidelines for the medication to relax the number of days into pregnancy that women can be given the pill. The move -- while not having a large impact on most states -- will affect a few that passed legislation dictating doctors adhere to the FDA label.

The Food and Drug Administration has relaxed the guidelines for taking a pill that induces abortion, reviving one of the most contentious issues of the abortion debate. The change allows women to use the drug further into pregnancy and with fewer visits to the doctor. The announcement on Wednesday came unexpectedly in the final stretch of the Obama administration and amid an election campaign in which both parties covet the women鈥檚 vote. Some abortion opponents charged that the new regimen was politically motivated. The F.D.A. said its actions were based strictly on medical science. (Tavernise, 3/30)

The Food and Drug Administration (FDA) notified the manufacturer of the drug Mifeprex in a letter on Tuesday that the drug is safe and effective for terminating a pregnancy in accordance with the new label. Also known as mifepristone or the abortion pill, the drug manufactured by Danco Laboratories is used in combination with another drug, misoprostol, to end a pregnancy. While abortion providers in most states already are using the protocol outlined in the new label, laws in effect in Ohio, North Dakota and Texas prohibited "off-label" uses of the drug and mandated abortion providers adhere to the older protocol approved in 2000. (3/30)

The new rules allow women to use the medication for 70 days after the start of their most recent menstrual period, up from 49 days under the previous guidelines. The agency also lowered the dosage of the medication, called mifepristone, from 600 milligrams to 200 milligrams, and made it easier for women to get a prescription for the pill. (Gomez, 3/30)

In practice, the situation will not change for most of those seeking abortions, as doctors for years have been diverging from the old FDA protocol on the basis of new research 鈥 a common practice known as prescribing a drug 鈥渙ff-label.鈥 But a handful of states have laws requiring abortion providers to adhere at least in part to the FDA-approved label, leading some providers to all but abandon the use of the abortion pill. (Somashekhar and McGinley, 3/30)

Health care providers have used the protocol approved Wednesday for years because scientific evidence showed it to be safe and effective. But in at least three states 鈥 Texas, Ohio and North Dakota 鈥 anti-abortion laws required health care providers to use only FDA-approved processes. In those states, medication abortions could be nearly impossible to obtain because of the added expense and doctor visits required. Typically, providers in the three states recommended more invasive surgical abortions, even when a woman was not far along into a pregnancy. Three other states 鈥 Arizona, Arkansas and Oklahoma 鈥 had passed similarly strict laws that were enjoined by the courts prior to the FDA announcement. (Haberkorn, 3/30)

Doctors in many states already followed common, evidence-based protocols that strayed from the FDA鈥檚 previous label for the drug, but Texas doctors were prohibited from doing so by state law. Among the provisions of the 2013 abortion law known as House Bill 2, Texas doctors were required to follow the FDA鈥檚 protocol for drug-induced abortions rather than evidence-based protocols. Texas abortion providers challenged that requirement in court, but a federal appeals court sided with the state and deemed it constitutional. The rule revisions are a win for abortion rights advocates, bringing Texas practices in line with dozens of other states. (Ura, 3/30)

Abortion rights advocates in Ohio celebrated a rare victory Wednesday when the federal Food and Drug Administration relaxed requirements for a medication that induces abortion, expanding access to the procedure. (Siegel, 3/30)

A quarter of abortions are drug-induced, according to an estimate by George Washington University鈥檚 Jacobs Institute of Women鈥檚 Health. The method involves taking pills under an abortion provider鈥檚 supervision and is less invasive than surgery. As its use has grown, abortion-rights supporters and opponents have more closely focused public policy on the method. ... In the past, the FDA recommendations included a 49-day window for a woman to access the initial dose of mifepristone after her last menstrual period, followed by a dose of misoprostol, another abortion-inducing drug. (Radnofsky and Burton, 3/30)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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