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The FDA could permanently lift some restrictions on abortion pills

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Activists participate in a candlelight vigil for abortion rights near the U.S. Supreme Court on Dec, 13, 2021 in Washington, D.C.
Alex Wong, Getty Images

Activists participate in a candlelight vigil for abortion rights near the U.S. Supreme Court on Dec, 13, 2021 in Washington, D.C.

Before the pandemic, doctors like Nisha Verma could only prescribe abortion pills to patients who came to her clinic in person. But at least for now, the Biden Administration is allowing patients to get the pills by mail.

"I think that makes it much more accessible for people where they don't actually have to physically come into a clinic, they don't have to expose themselves to COVID, they can do this all from the comfort of their home," said Verma, an OBGYN and abortion provider based in Washington, D.C.

Advocates say restrictions on the abortion pill are "outdated"

Last year, reproductive rights groups successfully sued to suspend the in-person dispensing rule, arguing it exposed patients to unnecessary risk from COVID-19. The Trump Administration fought that decision to the Supreme Court, which allowed the rule to be reinstated. Then, the Biden Administration stepped in this April to once again allow patients to receive the abortion pills by mail during the pandemic.

Verma said this mail option has been particularly helpful for women in rural areas far from the nearest clinic.

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Now, the Food and Drug Administration faces a Thursday deadline to complete a review that could lead to removing several restrictions on the pill, including making this easier access permanent.

A coalition of medical and reproductive rights groups asked the FDA to permanently remove the in person rule, and other restrictions, for the abortion pill mifepristone. As a result of litigation spearheaded by groups including the American Civil Liberties Union, the FDA agreed to review its regulations and report back.

Julia Kaye, an ACLU attorney, said years of data demonstrate that mifepristone is safe if used appropriately.

"At this moment, with Roe v. Wade hanging by a thread, it is especially urgent that the federal government do everything in its power to follow the science and expand access to this safe, effective medication," Kaye said.

As more states pass restrictions, Kaye said lifting "outdated" restrictions and making it easier for doctors to prescribe the pill could make abortion available for more people.

Major medical groups including the American Medical Association argue that since mifepristone was approved by the U.S. Food and Drug Administration in 2000, it's built up a strong safety record. Nonetheless, mifepristone is subject layers of restrictions beyond typical prescription drugs.

Abortion opponents have long fought easier access

Conservative activists have long fought efforts to relax the rules for mifepristone, which is approved by the FDA for use in combination with another drug to terminate pregnancies up to 10 weeks.

Groups opposed to abortion rights have taken note of the increasing popularity of abortion pills, which many patients choose out of a desire to avoid surgery, or to terminate pregnancies more privately at home. Today, about 40% of patients seeking abortions use pills rather than having a surgical procedure.

Melanie Israel, a policy analyst with the DeVos Center for Religion & Civil Society at the Heritage Foundation, said she worries that less oversight would put patients at risk.

"There is a reason that these safety protocols have been in place, and the abortion industry is really trying to seize this moment to remove those important safety restrictions and make abortion pills more widely available and more common," Israel said.

Doctors are allowed to prescribe the abortion pill in Canada

But a new study published last week in the New England Journal of Medicine, which reviewed data from more than 84,000 abortions, found no increase in complications after Canada made mifepristone available by a doctor's prescription in 2017.

Dr. Verma, who's also a fellow with the American College of Obstetricians & Gynecologists, which has lobbied to remove the FDA restrictions, said doctors prescribing the pills through telemedicine ask questions designed to rule out risk factors, including ectopic pregnancies. She said the pandemic has added to years of research demonstrating mifepristone's safety.

"We've really seen that this is completely safe and that these FDA regulations are based on politics; they're not based on science or evidence," she said. "Medications with similar risk, similar safety profiles, are not regulated the same way."

Verma points to the use of the same drug, mifepristone, to treat Cushing's syndrome – prescribed in a larger dose than is typically used to induce an abortion. That use of the medication is not subject to the same restrictions that constrain abortion patients.

Even if the FDA relaxes or removes the restrictions altogether, the battle over abortion pills will likely continue in state legislatures, where some lawmakers have passed their own restrictions. Earlier this month, a new law took effect in Texas that makes sending abortion pills through the mail a felony.

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