The Biden administration says it’s taking steps to increase access to medication abortion in response to the Supreme Court decision to reverse Roe v. Wade, but some of the administration’s own policies stand in the way of people trying to get the drug.
Mifepristone, the drug known as the abortion pill, has been approved in the U.S. for more than 20 years and has been shown to be safer than commonly used drugs like Tylenol. But federal regulations strictly limit the circumstances under which patients can get it. While the administration last year loosened some rules on prescribers, it added new hurdles for pharmacies to dispense abortion pills. Several states have regulations on top of that, limiting who can prescribe it or requiring people to attend in-person doctor’s appointments to get the pill.
The White House quickly pointed to the abortion pill as an answer to the post-Roe world in which some 33 million women could lose access to procedures in their home states. President Joe Biden ordered his health officials “to identify all ways to ensure that mifepristone is as widely accessible as possible,” according to a White House statement.
Health and Human Services Secretary Xavier Becerra said the administration was taking steps to increase access without sharing specifics. It’s unclear what the administration will be able to do. Becerra, whose department oversees the Food and Drug Administration, declined to say whether he would direct the agency to loosen restrictions on the abortion pill.
“Medication abortion — those treatments that FDA has signed off on as safe and effective — are available to be prescribed,” Becerra said at a news conference this week. “Under what conditions? Stay tuned.”
The FDA has been under pressure for years from medical and advocacy groups to loosen restrictions on the abortion pill. Leading medical bodies have called the rules unnecessary. In response to a lawsuit, the agency amended its policies and in December permanently allowed the abortion pill to be dispensed by mail but left other restrictions in place.
It also added a new restriction: any pharmacy that wanted to dispense the abortion pill had to be certified. That created another bureaucratic hurdle that continues to limit the pill’s reach.
“These pills have been around for decades now but they’ve been overregulated,” said Elisa Wells, co-founder of Plan C, an organization that helps women access abortion pills online. She said the FDA’s restrictions should have been lifted “decades ago, so these safe and effective pills could be made available through pharmacies, just like any other pills.”
Despite its safety record, mifepristone is only available to patients under a risk evaluation and mitigation strategy, or REMS, that requires education and monitoring for doctors and patients. Such policies are normally reserved for drugs with exceptionally rare and dangerous side effects.
The American College of Obstetricians and Gynecologists opposes the restrictions on mifepristone, saying that “decades of evidence and the consensus of the medical community underscore” the drug’s safety, according to the professional group’s website. The American Medical Association has also repeatedly called for the FDA to remove the safety requirements.
Late last year, the FDA said that patients need only a virtual doctor visit to get the drug, permanently lifting a requirement for in-person consults that had been relaxed during the pandemic. But with that, the agency added a new requirement for the manufacturers — Danco Laboratories LLC and GenBioPro Inc. — to certify pharmacies before they can dispense the medication.
