FDA expands abortion-pill access in states seeking limits

Guidelines the Food and Drug Administration issued Wednesday could expand women’s access to an abortion-inducing pill in states that have sought to limit its use.

The new guidelines strike directly against laws passed by several states — including North Dakota, Ohio and Texas — that require doctors to adhere to 16-year-old FDA regulations. Several other states have tried to limit use of the drug, but their efforts face legal challenges around the country.

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.

The previous requirements had been in place since 2000, but the FDA said in a statement that more recent scientific data showed that it was time for the update.

"After reviewing the supplemental application, the agency determined that Mifeprex is safe and effective when used to terminate a pregnancy in accordance with revised labeling," the statement said, referring to the brand name of the drug.

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Abortion rights groups hailed the move as a long-needed dose of common sense given the history of the medication.

President Ilyse Hogue of NARAL Pro-Choice America, a network of groups dedicated to protecting and expanding reproductive freedoms, said the abortion pill has proved through decades to be safer than Tylenol, Viagra and other common medications used around the world.

"Unlike state and federal anti-choice laws that restrict a women's access to an abortion, the FDA decision to make mifepristone available to more women in this country is based on science that shows this usage is safe and medically sound," Hogue said. "It's high time to put medicine back into the hands of medical professionals and take it out of politicians' hands."

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Abortion opponents disagreed, arguing that lengthening the time that women can use the pill will lead to more "incomplete" abortions and more risks to mothers. President Troy Newman of Operation Rescue, a Kansas-based anti-abortion group, said pharmaceutical companies will use the FDA's decision to persuade more "vulnerable pregnant women" to use the "unpredictable" drug.

"The FDA should be more about protecting the public from exploitative and predatory uses of drugs rather than pandering to Planned Parenthood and the rest of the Abortion Cartel," Newman said in a statement.

Ohio's lawmakers had passed the requirement to follow FDA guidelines in 2004, but the law didn't take effect until 2011 because of a court order. From 2010 to 2011, when the law went into effect, surgical abortions dropped to by more than 75% to 1,234 from 5,862, according to state health department records.

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By 2014, non-surgical abortions including the abortion pill were 5% of all procedures, compared to 13.2% in 2004.

Women's Med in Sharonville, Ohio, which ceased surgical abortion in 2014 after losing a legal battle with the state, still provides medication abortions. But it has used methotrexate injections rather than the abortion pill because administering Mifeprex according to the old FDA guidelines was too expensive and time-consuming, said Dr. Martin Haskell, the clinic's owner.

But Wednesday's FDA decision gives Haskell another cost-effective alternative for abortions — one he said he will consider offering to patients in the future.

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“They’re finally catching up with reality,” Dr. Franz Theard, a physician who operates Hilltop Women’s Reproductive Clinic in El Paso, said of the FDA. Texas law requires pregnant women seeking abortions to first fill out paperwork, get an ultrasound and receive counseling.

They return 72 hours later to take mifiprex. Then they are sent home where they take a second drug, misoprostol, all in keeping with the FDA's 2000 guidelines because state law prohibits off-label use of drugs that can be used for abortions.

“We tell them, ‘Don’t go to work,’ ” because the procedure causes cramping, Theard said. But it is much less invasive than a surgical abortion and so trouble-free for some women that almost a third don't return for a recommended follow-up after the abortion.

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In Arizona, where a court order has put its state law similar to Ohio and Texas on hold, lawmakers sent a new bill to the governor last week requiring abortion-inducing medications be administered according to FDA protocol that was in effect as of Dec. 31.

The legislation is sitting on Gov. Doug Ducey's desk, awaiting his signature or veto. Bill proponents are scrambling to figure out what to do.

"They will not be following the (current) FDA recommendations if this bill becomes law," said state Rep. Randall Friese, a Tucson Democrat and a surgeon who asked Ducey to veto the bill. "I'm hoping this information makes it to the governor's office to help him decide."

Contributing: Jessie Balmert, The Cincinnati Enquirer; Marty Schladen, El Paso Times; Alia Beard Rau, The Arizona Republic. Follow Alan Gomez on Twitter: @alangomez