Supreme Court justices are hearing arguments to overturn the FDA’s more than 20-year approval of mifepristone, and roll back the 2016 changes that made it easier for patients to get.
"The idea that the FDA can be overridden by federal courts is really profoundly radical," said Harry Nelson, health care attorney and managing partner at Nelson Hardiman.
Mifepristone is one of two drugs — the second being misoprostol — which the FDA approved to be taken together for a medication abortion. The medication is only approved as a one-dose pill, and only approved for patients up to 10 weeks pregnant.
The drug impacts progesterone, a key hormone in menstruation and pregnancy.
"There are over 100 peer-reviewed publications and over 20 years of evidence showing that medication abortion is safe and effective," said Ushma Upadhyay, professor and public health scientist at the University of California San Francisco.
Mifepristone is also used for miscarriages, uterine fibroids and Cushing’s syndrome. Without mifepristone, patients can take misoprostol only or have a procedure that can include surgery, all of which carry more health risks.
Nelson warns certain court outcomes could set a dangerous precedent for politics in the drug approval process.
"It’s going to really upend the process by which we decide what medications are safe and what medications people have access to," he said.
New research out this week shows that in the six months after Roe was overturned, roughly 27,000 more self-managed medication abortions than expected occurred.
Research has shown telehealth abortion plays a key role for patients under a time-crunch since the FDA only allows for 10 weeks.
Supreme Court appears skeptical of abortion pill challenge
For the second time in two years, the Supreme Court is considering a case that will have a significant impact on abortion access.
