It took a pandemic, a lawsuit and an eight-month review of the evidence, but the Food and Drug Administration has finally loosened some of the restrictions it imposed 21 years ago on mifepristone, which is used together with a second medication, misoprostol, for medication abortion. While the FDA could have gone further, this move is based on solid scientific evidence and will improve access to abortion care for at least some people.
At issue was the FDA’s risk evaluation and mitigation strategy, or REMS, an extra layer of regulatory scrutiny that the agency applies to a small number of drugs that have safety concerns. Given decades-long experience with mifepristone and documenting the safety of the medication, physicians and researchers have been urging the FDA for years to remove mifepristone’s REMS. Not only was there no clear rationale about how the restrictions on mifepristone improved the drug’s safety, but there are many medications, including Viagra, with more significant risks without a REMS.
Instead of completely withdrawing the REMS, the FDA moved to modify it — most significantly by removing the requirement that the pill be dispensed in person at a clinic, medical office or hospital. The in-person dispensing requirement has always been a barrier for patients, especially if they live far from a clinic; it was also an obstacle for clinics, since it’s a hassle to stock the medication, which is costlier than many other drugs. In a survey of obstetrician-gynecologists, we found that the number of physicians willing to provide medication abortion would approximately double if the in-person dispensing requirement were removed.
During the coronavirus pandemic, the in-person dispensing requirement put patients at unnecessary risk of viral transmission, forcing them to come into a clinic to receive a service that they could have obtained by telemedicine. Other countries, including the United Kingdom, quickly modified protocols for providing medication abortion using telemedicine and mailing the pills to patients. An evaluation of the U.K. service — including more than 18,000 telemedicine medication abortions — found that it was safe and effective.
The FDA refused to lift the in-person requirement until a federal judge ordered it to do so in July 2020. The policy was intermittently in effect until the FDA stated in April that it would temporarily allow clinicians to mail mifepristone to patients or use a mail-order pharmacy to provide medication abortion for the remainder of the public health emergency. During this time, U.S. researchers published four large studies on medication abortion provided without in-person dispensing including over 1,700 patients. All the studies confirmed the treatment’s safety and effectiveness.
It is heartening to see that the FDA followed this large body of evidence and permanently removed the in-person dispensing requirement. It also went a step further than the temporary order from April by stating that any certified pharmacy could dispense mifepristone. Bricks-and-mortar pharmacies can safely provide medication abortion, and they might reduce delays that patients could face when receiving pills by mail. Of course, not every pharmacy will choose to stock mifepristone, but even if some do, access could be improved.
While the FDA’s decision is mostly good news, I’m left wondering why the agency did not completely remove the REMS limitations. The remaining components — a certification process for providers and pharmacies and a form that patients must sign — seem like window dressing meant to appease conservative lawmakers. These requirements don’t improve the safety of medication abortion; they can be a barrier to provision, and they are confusing to patients. Canada doesn’t require any of them, and medication abortion is provided safely there.
In the short term, the FDA’s move will have limited impact in the states where patients face the greatest barriers to abortion access. Nineteen states, mostly in the Midwest and South, have laws requiring physicians to dispense mifepristone in person. In addition to its devastating ban on abortion at around six weeks’ gestation that the Supreme Court has allowed to remain in effect, Texas has at least two other laws that prohibit telemedicine provision of medication abortion.
These bans are having the greatest impact on patients who are Black, Indigenous or other people of color, as well as those living on low incomes. Together those people make up the majority of abortion patients. It remains to be seen if litigators could use the recent FDA decision to challenge these state laws that conflict with federal policy.
Abortion is health care, and our federal agencies should regulate abortion services and medications using the same criteria applied to other areas of medicine. Lifting the in-person dispensing requirement is an important first step to treat mifepristone more like other drugs, but the eventual goal remains complete removal of the REMS. Until then, we’re letting abortion exceptionalism get in the way of evidence-based medicine.