FDA Relaxes Restrictions on Access to Abortion Pill by Mail

The Food and Drug Administration has announced it will relax controversial restrictions on a heavily regulated medication used to induce abortions — easing access to the drug at a time when abortion rights are being increasingly restricted nationwide.

The drug, mifepristone, is approved for use in combination with another medication, misoprostol, to terminate pregnancies of up to 10 weeks and is sometimes used to treat patients experiencing miscarriages.

Before the coronavirus pandemic, doctors could prescribe the pills only to patients who were able to pick them up in person. But in response to COVID-19, the Biden administration suspended that requirement, allowing them to be mailed to patients instead. The decision by the FDA on Thursday makes that change permanent.

Advocates said restrictions on the abortion pill were 'outdated'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 at 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.

Doctors like Nisha Verma said this mail option has been particularly helpful for residents of rural areas far from the nearest clinic.

"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 OB-GYN and abortion provider based in Washington, D.C.

In California, state law protects the right to obtain an abortion before viability is guaranteed. That assurance, however, doesn’t always mean it’s easy to terminate a pregnancy, especially in the more rural regions of the state.

In a 2017 study, the Guttmacher Institute, an abortion-rights advocacy and policy organization, found that some 40% of mostly rural counties in California had no clinics that provided abortions. That means even in a state with some of the nation's most progressive abortion laws, many must travel over 100 miles to find a provider.

A coalition of medical and reproductive rights groups from across the country asked the FDA to permanently remove the in-person rule, as well as other restrictions, for 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 Food and Drug Administration in 2000, it has built up a strong safety record. Nonetheless, mifepristone is subject to layers of restrictions beyond those applied to typical prescription drugs.

Abortion opponents have long fought easier access

Conservative activists have long fought efforts to relax the rules for mifepristone, taking 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 and 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.

Verma, who is also a fellow with the American College of Obstetricians and 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 with the FDA decision, the battle over abortion pills likely will continue in state legislatures, where some lawmakers have passed their own restrictions. This month, a new law took effect in Texas that makes sending abortion pills through the mail a felony.

This post includes reporting from KQED's Katie Orr.