Lifting FDA regulations could help family doctors provide medication abortion

a box of Mifeprex. Photo by Robin Marty.

April 20, 2022

In 2000, the Federal Drug Administration approved mifepristone for medication abortion. Many advocates hoped that the availability of the drug would allow primary care clinicians to integrate abortion services in their practices. However, more than 20 years later, most abortions still take place in specialized abortion clinics, with only 1% happening in physicians’ offices.

Medication abortion by family physicians offers an opportunity to enhance access to person-centered medication abortion care. It can also help destigmatize abortion for patients and providers by normalizing it as part of full-spectrum care. While state laws and health system restrictions can be barriers, another is the FDA’s Risk Evaluation Mitigation Strategy (REMS) for mifepristone. The REMS is an outdated set of requirements that providers who want to offer medication abortion must follow. While the FDA recently revised these burdensome regulations, it kept provisions requiring providers to get certified and for patients to sign a Patient Agreement Form.

Bixby Center researchers and colleagues looked at the burden of the REMS as part of a study exploring how family medicine values can be used to encourage family physicians to integrate medication abortion into their practices. 

The first issue they identified was that the REMS require clinic administration to get involved. The need to navigate regulations and logistics meant that physicians with unsupportive clinic leadership were unable to provide medication abortion. As one abortion provider in the Northeast said, “If you don’t have a local champion, you don’t have someone who’s willing to put the time and effort into it, it’s hard to do, right. It’s easy for me to prescribe like antibiotics, but it’s not so easy for me to prescribe mifepristone ‘cause of all the stuff around it.”

The other issue that came up was that clinics didn’t feel it was worth the trouble of complying with the regulations given the low number of abortions they provide. “Many primary care clinics think, oh, if our volume is low, like why bother going through all of this headache to be able to provide the service when, you know, we have maybe like 4 a week or something like that,” said a physician in the south.

While this study took place before the changes to the REMS, it provides insights into how the decision may impact family physicians’ ability to provide medication abortion. The FDA’s removal of in-person dispensing may encourage family physicians whose clinical sites didn’t support providing it before. However, physicians interviewed still encounter a range of barriers to provide medication that the revised REMS won’t alleviate. The certification requirements may continue to serve as gatekeepers for some providers. The requirement that patients sign a Patient Agreement Form may also be limiting, especially since having the form on site and incorporating it into medical records requires involvement of clinic administration.

The decision to revise the REMS on mifepristone has been long overdue, yet it doesn’t go far enough. By permanently and fully removing the REMS, family physicians and other primary care providers could more easily incorporate medication abortion into their practices. That change can better honor patients’ preference for where to get an abortion, reduce stigma for providers and patients, and improve abortion access for millions across the United States.