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Some states used an FDA loophole to limit the abortion pill. The FDA just closed it.


The Food and Drug Administration (FDA) took an action Wednesday that will significantly expand women's access to medication abortion — and totally derail an anti-abortion lawmaking strategy in the process.

The FDA officially changed its approved drug regimen for mifepristone (brand name Mifeprex), which is used together with misoprostol to end an early pregnancy. This particular "label change" is one that reproductive rights advocates have been seeking for more than a decade.

The label for mifepristone hasn't been updated since 2000, and doctors have learned a lot about the drug since then. They've learned that women can take just a third of the original dose, which produces fewer side effects and makes it less expensive, and that it's fine for women to take some of the pills at home rather than make an extra trip to the doctor's office. It's also safe to take the drug later in pregnancy than was previously thought — women can now take the pill for pregnancies up to 10 weeks' gestation instead of seven.

But some states have tried to make it harder for women to get medication abortion by requiring doctors to abide by the outdated FDA guidelines.

Using the old guidelines instead of newer best practices means that women have a shorter window to find out that they're pregnant and make an appointment. They also have to take more medicine and spend more money than they otherwise would. Women also have to make extra trips to the clinic to take both medications in a doctor's presence, which is an extra burden in states like Texas, where women often face long driving distances to abortion clinics and have to make four separate trips to the doctor to comply with waiting period and medication abortion laws.

It can take the FDA a long time to change the official label for an approved drug, and a lot of drug companies don't bother with the time and expense of the process. That's because it's totally normal for doctors to prescribe drugs "off label" once there's clear medical evidence that doing so is a good idea. They don't have to wait for the FDA to make it official.

So states that required the old protocol weren't doing it for any compelling health reason. This kind of law is one of many that anti-abortion lawmakers have passed to restrict abortion access at the state level over the past five years.

Some laws requiring the outdated FDA protocol have been blocked by courts, but they are in effect in Texas, Ohio, and North Dakota. Arizona's governor was preparing to sign a similar bill, but now that law's future is uncertain.

Many women prefer medication abortion because it's less invasive and allows them to have a miscarriage at home. It can also be a good option for women who live in rural areas far away from a doctor's office. But as the use of medication abortion use has risen nationwide, it has fallen sharply in states like Texas that mandate the outdated protocol.

Now, however, those laws don't have any power to change how doctors would normally recommend women use medication abortion.

"As physicians, we work every day to provide the highest quality care to our patients," said Dr. Nancy Stanwood, board chair of Physicians for Reproductive Health, in a statement. "An updated label means that providers in states that require adherence to the FDA-approved Mifeprex label will not have to practice outdated medicine."

This doesn't mean attacks on medication abortion at the state level are over. There are still plenty of ways to restrict it, like banning the use of telemedicine to prescribe abortion pills for women in rural areas. And abortion opponents have proven very creative at coming up with new kinds of laws entirely. But for now, this is a pretty significant pro-choice victory.