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FDA relaxes requirements for taking abortion pill

Since the FDA approved medication that induces abortion, states have passed a number of different laws to restrict its use.
Since the FDA approved medication that induces abortion, states have passed a number of different laws to restrict its use. AP

The Food and Drug Administration stepped into the politics of abortion Wednesday, relaxing the requirements for taking a medication that induces abortion, a move that is expected to expand access to the procedure.

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 FDA 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 Many doctors say the original labels, based on clinical evidence from the 1990s, were outdated and that the state laws went against accepted medical practice and made it harder for women to get abortions.

The changes announced Wednesday reduce the number of trips women have to make to a doctor from three to two in most states, and also increase the number of days that women have to be able to use medication to induce abortion from 49 to 70 days after the beginning of their last menstrual period, experts said. The new label also reduces the dosage of the drug, called mifepristone, from 600 milligrams to 200. Most medical societies had said the previous dosage was too high, and abortion rights advocates said it increased the cost and the side effects of the procedure.

In most states, doctors had been following the medically-accepted regimen, despite the fact that the label advised otherwise. That is fairly common in medical practice and is known as off-label use.

“This is a huge step in increasing access to medication abortion and it comports with the scientific evidence,” said Elizabeth Nash, a senior state issues associate at the Guttmacher Institute, which tracks women’s reproductive health issues. She said that medication abortions accounted for about a quarter of all abortions in 2011, the last year measured by the institute.

The FDA 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.

The American Congress of Obstetricians and Gynecologists said in a statement that it was “pleased that the updated FDA-approved regimen for mifepristone reflects the current available scientific evidence and best practices.”

The group added that “medication abortion has been subject to legislative attacks in various states across the country, including mandated regimens that do not reflect the current scientific evidence. We hope that these states take the FDA label into account.”

Planned Parenthood, which has fought the state laws, said in a statement: “The benefit of this announcement will be most immediately felt by women and providers in Ohio, Texas and North Dakota,” states that have laws requiring medication abortion to be provided according to the original label.

Similar restrictions on medication abortion have passed but have been blocked by court order in Arkansas, Oklahoma, and Arizona. Arizona legislators have passed yet another measure that tries to maintain the original FDA protocol, but it has not yet been signed into law.

Since the FDA approved the medication, states have passed a number of different laws to restrict its use. Some require medical professionals who administer the drug to be licensed physicians, and not nurses or physician assistants. Other states require the prescribing doctor to be physically present with the patient, a rule that abortion rights advocates say blocks rural women from receiving the medication through telemedicine.

Dr. Raegan McDonald-Mosley, chief medical officer of Planned Parenthood Federation of America, said the change would reduce confusion among patients who had to sign two sets of consent forms, one with the regimen recommended by much of medical science and one that detailed the requirements on the FDA label.

“Now those two things are in sync,” she said.

McDonald-Mosley said that medication abortion is an increasingly popular method: About half of women in Planned Parenthood clinics who fall within the time limit choose it.

Jan Hoffman contributed reporting.

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