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Trump appointee Matthew Kacsmaryk said Wednesday he would issue a ruling in case challenging FDA approval of mifepristone as soon as possible
Lawyers for the Alliance for Hippocratic Medicine, a coalition of anti-abortion medical groups, are hoping to convince Judge Matthew Kacsmaryk to order the FDA to withdraw its 22-year approval of mifepristone, the first drug taken in the two-drug abortion pill regimen. Convincing the judge is not expected to be difficult: before he was appointed to the federal bench, Kacsmaryk was the deputy general counsel of a religious rights legal group much like the one representing the plaintiffs, and he has written openly about his anti-abortion beliefs.
At Wednesday’s hearing, the judge said he planned to issue a ruling as soon as possible. If Kacsmaryk orders the FDA to withdraw approval for mifepristone, it will unleash immediate chaos and confusion across the country, touching off a race to appeal the ruling, intensifying an existing debate about whether the Biden administration should defy the court, forcing providers to turn to less effective methods, and sending women scrambling to find alternative means to terminate unwanted pregnancies.
In spite of the enormous stakes of the case, Kacsmaryk has sought to keep the proceedings hidden from public view. Wednesday’s hearing was scheduled during a conference call held in secret on Friday, and only added to the public docket after reporters learned of it. In a transcript of the call that was later made available, Kacsmaryk asked the lawyers directly to “avoid further publicizing the date of the hearing,” adding, “I think less advertisement of this hearing is better.”
Some of those who scrambled to reach Amarillo by Wednesday morning were turned away by the court. Elisabeth Smith, director of state advocacy at the Center for Reproductive Rights, which represents clinics that provide abortion care across the U.S., says she was outside the courtroom at 6 a.m., but was nonetheless among those shut out of the proceedings.
“The outcome of this case could impact the entire country. The court should be making every effort possible to ensure the public has visibility into what is happening, but instead the opposite has happened,” Smith said in an emailed statement. “We are alarmed by this attempt to conceal what should be public information, especially in such a consequential case.”
The case, ACLU senior staff attorney Lorie Chaiten told Rolling Stone in January, should never have made it this far: “It is baseless… It’s time-barred. It has enormous jurisdictional defects. In the normal world, this case gets dismissed.” According to the FDA, more than 3.7 million Americans have used mifepristone, which is taken together with another drug, misoprostol, to terminate unwanted pregnancies since the agency approved the abortion pill in 2000. Mifepristone, it is often noted, has a better safety record than either Tylenol or Viagra.
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, sublingually (i.e. absorbed under the tongue) or vaginally, largely as a matter of personal preference, Grant says. (Swallowing the medication 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 in your vagina.”)
Elisa Wells, co-founder and co-director of Plan C, an organization that helps individuals obtain abortion pills, says regardless of Kacsmaryk’s decision, women will still have options. “There is a robust alternate supply system of pills in this country,” she says, listing organizations like Aid Access, a physician-moderated service that operates out of Amsterdam and sources generic pills from an Indian pharmacy, as well as feminist networks like Red State Access and Las Libres.
“We have long believed that we can’t rely on our courts and our legislatures to protect our access to what should be basic health care: abortion,” Wells says. “We expect these attacks, and we know that they will not be successful in stopping access.”
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