Wednesday's hearing by Texas federal judge Andrew Kacsmaryk made it very clear he will attempt to overturn the FDA and two decades of medicine in order to end medical abortion for everyone, and the Biden administration has a momentous decision to make, as Rolling Stone's Tessa Stuart reports.
Under federal law, anyone can challenge FDA approval of a drug within the first six years — a window has long since closed for mifepristone, which the FDA approved in 2000. According to the Washington Post, when asked on Wednesday if there was precedent for a court intervening in an approval so many years after a drug had been on the market, a lawyer arguing on behalf of the Alliance for Hippocratic Medicine admitted there was none.
But Kacsmaryk nonetheless appeared poised to rule in the anti-abortion groups’ favor on Wednesday. If that happens, lawyers for the Biden Administration will seek a stay from the Fifth Circuit — one of the most conservative courts in the country — and if they can’t find relief there, they will appeal to the Supreme Court. It’s unclear how long that might take and whether mifepristone would be available in the meantime.
If Kacsmaryk orders the FDA to withdraw approval of the drug, Sen. Ron Wyden has called on the Biden Administration to ignore the order and maintain public access to the medication. (It’s not an idea without precedent, according to a Harvard Law Review article that examined federal agency compliance with court orders, and judges like Kacsmaryk have relatively few options to force an agency, like FDA, to comply with their orders if an agency chooses not to.)
Wyden’s position is simple: “The power of the judiciary begins and ends with its legitimacy in the eyes of the public,” he said last month. “A judge’s rulings stand because elected leaders and citizens have agreed that abiding by them is right and necessary to uphold the rule of law… But the judiciary must uphold its end of the social contract too. It must follow the rule of law and earn the confidence of the American people continually, every day, every month, every year.”
By “hot-wiring the system in order to produce an anti-abortion ruling,” Wyden says, Kacsmaryk is violating that contract and delegitimizing the court itself. (The White House did not respond to a request for comment on Wyden’s suggestion.)
Health care providers, meanwhile, are making plans to continue offering abortions using misoprostol, the second pill in abortion pill regimen, alone. (Misoprostol, which is also used to treat ulcers, is available without the restrictions to which mifepristone is subject.)
Melissa Grant is the chief operations officer at Carafem, an organization that offers reproductive health care, including abortion care, online and in-person. “Carafem has provided thousands of doses of misoprostol-only as an option to our clients since the year 2020,” she tells Rolling Stone. “We did so because we recognized that the Trump administration was poised to remove the ability to mail mifepristone in 2021.”
What Carafem has found in the data it has collected over that period is that misoprostol-only abortions are extremely effective — 95 percent, compared to 99 percent effectiveness when taken together with mifepristone. Doses can be administered orally or vaginally, largely as a matter of personal preference, Grant says. (While taking the medication orally is slightly less effective, she says, but individuals in areas where abortion is illegal may choose that route out of abundance of caution since “fragments of tablets may be maybe seen on a pelvic exam and your vagina.”)