FDA's power tested by dueling abortion pill rulings
Last week’s dueling court rulings on abortion pills are refocusing attention on what legal powers the Food and Drug Administration has over prohibited drugs — and when it can disregard a prohibition.
The big picture: If a Texas federal judge's ruling stands, and the abortion drug mifepristone no longer has FDA approval, then manufacturing, selling and distributing it will be outlawed.
- But some legal experts say the agency has discretion to chart a path forward and keep some semblance of the status quo.
- They cite a 1985 Supreme Court ruling that held agency decisions not to take enforcement actions aren’t subject to judicial review.
- And, they note, there’s already an established legal path for revoking a drug approval that involves public hearings and gives the manufacturer a say.
Catch up fast: Texas District Judge Matthew Kacsmaryk issued a decision pausing the FDA's 2000 approval of mifepristone, which is set to take effect on Friday.
- But Washington District Judge Thomas Rice said in a simultaneous decision that mifepristone authorization cannot be taken away because it would alter the "status quo."
- The Washington state decision, unlike Texas', takes effect immediately, said Oregon Attorney General Ellen Rosenblum, co-lead of a group of Democratic attorneys general who brought the case.
Zoom in: The argument for FDA enforcement discretion was laid out in the aftermath of Friday night's rulings by University of Pittsburgh law professor Greer Donley and Rachel Rebouche, dean of Temple University's Beasley School of Law, in the blog Abortion, Every Day.
- They note the FDA can issue a notice and lay out guidance about how it will respond to the court orders, and possibly reiterate the position that mifepristone is safe and should remain part of the medication abortion regimen.
- The agency would therefore comply with the Washington state federal court ruling.
The other side: “The FDA never had the authority to approve these hazardous drugs and remove important safeguards,” said Erik Baptist, a senior attorney for Alliance Defending Freedom, which is representing the anti-abortion groups in the Texas lawsuit.
- “[I]t’s high time the agency is held accountable for its reckless actions,” baptist added.
Of note: Kacsmaryk's decision attempts to go around the FDA, by not explicitly ordering the agency to do anything but by staying the effective date of the agency's approval.
- Some public health experts like the University of Minnesota's David Boulware fear if judges can impose their interpretations and stay an FDA approval, activists will seek the same remedy to invalidate vaccines or contraception.
Yes, but: While the FDA could assert administrative power and maintain access to medication abortion, the legal tussle is still subject to many more twists and turns, and would ultimately take up the bigger question of how much authority a federal agency has.
- The case is expected to end up at the Supreme Court, which would consider the way in which the FDA approved mifepristone in 2000 and whether an 1870s federal law known as the Comstock Act prohibits the mailing of abortion pills, Donley and Rebouche said.
What we're watching: The Biden administration has already appealed the Texas decision to the conservative-leaning U.S. Fifth Circuit Court of Appeals.
- The government said it's still reviewing the Washington ruling.