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Federal officials said they were changing the label for mifepristone, a drug approved by the Food and Drug Administration in 2000.PHOTO:NEWSMAKERS/GETTY IMAGES
(THE NEW YORK TIMES) Federal regulators on Wednesday issued new recommendations on drug-induced abortions that may make it easier for women in some states to obtain the procedure, a move that comes at a particularly charged moment in the national debate.
The Food and Drug Administration said it would change the label for mifepristone, themainpill used in the procedure, in a way that would effectively sidestep state laws aimed at restricting drug-induced abortion. While FDA guidelines for the use of drugs aren’t binding, a half-dozen states, including Texas and Ohio, have passed laws requiring abortion providers to adhere to the FDA’s recommendations for the procedure. Abortion providers say that has effectively made drug-induced abortion more expensive and difficult to obtain.
A quarter of abortions are drug-induced, according to an estimate by George Washington University’s Jacobs Institute of Women’s Health. The method involves taking pills under an abortion provider’s supervision and is less invasive than surgery. As its use hasgrown, abortion-rights supporters and opponents have more closely focused public policy on the method.
Across the nation, states have sought to regulate abortion in a variety of ways in recent years, and the extent to which they may take such steps is now before the Supreme Court. Meanwhile, President Barack Obama’s potential successors continue toset their positions on abortionin primary jousting that is likely a precursor to further debates on the subject this fall.
Congressional Republicans, meanwhile, are continuing to investigate fetal-tissue research and on Wednesday issued subpoenas as part of that effort.
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. Both were to be taken in a provider’s office. The drug’s new label reduces the size of the initial dose and extends the window for taking it to 70 days, and says the second drug can be taken “at a location appropriate for the patient.”
Many abortion providers said the earlier recommendations were out-of-date with scientific research and that where they could, they had already switched protocols to what they considered to be best practice.
Susan F. Wood, associate professor of health policy at George Washington University, said the “immediate effect of the change is to reflect what has already been going on in clinical practice.” She said that restrictions in states that limited doctors to the higher dose “had reduced the use of medication abortions.”
She said the change in time frame has been because of “experience and studies done showing it is effective at least until 70 days.” The original limit was simply because the 1990s studies that led to the FDA label tested mifepristone up to 49 days—not because it was a magic number.
Dr. Wood also said she thought the FDA’s step “may increase access to early medication abortions, and may increase the percentage.”
The Jacobs Institute of Women’s Health late last year estimated there were 240,000 drug-induced abortions in 2011 in the U.S., out of 1.06 million total.
Abortion opponents have accused providers of overlooking patients’ interests for a procedure that they say carries risks, and seeking to evade government regulation on their activities.Laws they have backed in several other states—such as Arkansas, Arizona and Oklahoma—have been blocked by the courts, according to the Guttmacher Institute, a think tank that supports abortion rightsand that follows state legislative activity.
In 2012, theOklahomaSupreme Court struck down a state law requiring that drug-induced abortions be conducted according to the FDA protocol. That court found the law “so completely at odds with the standard that governs the practice of medicine that it can serve no purpose except to prevent women from obtaining abortions.”
The U.S. Supreme Court declined to review that decision.The court is nowconsidering parts of a Texas lawrequiring clinics to meet the standards of ambulatory surgical centers, where outpatient operations are performed, and requiring doctors performing abortions to hold admitting privileges at a nearby hospital. That law also includes a restriction on drug-induced abortion.
Justice Anthony Kennedy, the likely swing vote in that case, signaled during a March oral argument that he was concerned the Texas restrictions had impeded drug-induced abortion and increased surgical abortions as a result, adding that in his opinion, “this may not be medically wise.”
More states also have passed laws requiring a clinician prescribing such a drug to be physically present with the patient, which prevents women in rural areas, in particular, from obtaining an abortion remotely by videoconference or telephone.
Abortion-rights groups said they hoped providers in states such as Texas could begin using the new protocols within days.
“Updating the label to reflect best medical practice represents a significant step forward,”said Raegan McDonald-Mosley, chief medical officer of Planned Parenthood Federation of America.
Americans United for Life, an antiabortion group that has led efforts to pass drug-induced abortion restrictions in the states, said women had been harmed by the procedure.
“While the abortion industry will falsely celebrate the label change as a green light to its practice of skirting regulations, it would be wise to remember that women and girls have been injured and killed,”said Anna Paprocki, a staff attorney at Americans United for Life.
Ohio state Rep. Thomas Brinkman, a Republican and a main sponsor of Ohio’s law mandating the state follow FDA guidelines on the drug, said the new labeling could pose a risk to women. “I would be very concerned about the health implications for the mothers,” he said.
The FDA continues to warn mifepristone, which is marketed as Mifeprex and is also known as RU-486, can causeside effects including heavy bleeding and nausea, and that “serious and sometimes fatal infections and bleeding occur very rarely.”
The drug’s maker, Danco Laboratories LLC, said it has been used by more than 2.75 million U.S. women. At the time of the latest FDA public-safety announcement on the product, in 2011, the agency said 14 women on the drug had died, with eight of those being from septic infections in the bloodstream. At the time, 1.52 million women had taken the medicine.
In addition to the deaths, the agency reported 612 hospitalizations and 256 infections, many of whom were among those hospitalized.
The Obama administration has had a turbulent relationship with women’s health groups, in particular over contraceptive and abortion drugs.
Advocates have cheered federal officials for their efforts to ensure contraception coverage through the Affordable Care Act by creating a workaround system for religiously affiliated employers with moral objections. That effort is alsocurrently before the Supreme Court,whichon Tuesdaytook the unusual stepof inviting parties to make additional suggestions for a potential compromise.
But activists have also criticized top federal officials for trying toblock the sale of emergency contraceptionwithout a prescription to anyone regardless of age. FDA officials had backed the move before they were overridden. In 2013, the administration formally approved an application from Teva Pharmaceutical Industries Ltd. to sell its Plan B emergency-contraceptive pill under those circumstances after a court order.
