FDA

What a shitshow.

The future of medication abortion in the United States remains up in the air after a federal judge heard arguments Wednesday in a suit challenging the Food and Drug Administration’s long-standing approval of mifepristone.

U.S. District Judge Matthew Kacsmaryk said he would rule “as soon as possible” on the challenge brought by the Alliance Defending Freedom, a conservative, anti-abortion law firm.

ADF is asking Kacsmaryk to suspend — and ultimately withdraw — the FDA’s approval of the medication, which would have nationwide implications, especially in states where abortion remains legal. In the hearing, a lawyer for ADF conceded that this would be unprecedented, but argued that the court had the authority to intervene to prevent harm.

Lawyers for the Department of Justice and Danco Laboratories, the pharmaceutical company that produces generic mifepristone, argued that the lawsuit is meritless.

Granting a preliminary injunction would be “depriving patients and doctors of a safe and effective drug,” argued Julie Straus Harris, with the DOJ.

Since it was initially approved in 2000, mifepristone has been found to be overwhelmingly safe and effective for terminating pregnancies. Citing that body of evidence, the FDA has recently relaxed restrictions on the medication, which is used in the majority of the abortions in the United States.

In the suit, ADF is representing anti-abortion medical organizations and doctors who argue they have been harmed by having to treat patients who have experienced adverse effects from the medications — and that they anticipate increased harm as a result of these loosened restrictions.

They also argue the drug was initially approved improperly under an FDA regulation that fast-tracks drugs that treat serious illnesses.

“Pregnancy is not an illness,” said Erik Baptist, a lawyer for ADF, in Wednesday’s hearing. “Mifepristone doesn’t treat anything.”

Kacsmaryk, appearing to give weight to that argument, listed off all the drugs that were approved under this regulation before mifepristone, most of which treat HIV and cancer. Separately, he summarized Baptist’s argument as asking the court to “deem one of these not like the others.”

The hearing, which ran more than four hours in Kacsmaryk’s Amarillo courtroom, covered a wide range of arguments. But the central question before Kacsmaryk is not as much about abortion as it is about administrative procedure — and whether the plaintiffs have any right to bring this lawsuit at all.

See here and here for the background. I can’t overstate how ridiculous this all is, and that includes the extreme restrictions on coverage of the hearing, for which you literally had to be there or at a single courthouse in Dallas, but only a handful of people were allowed at the courtroom, and cellphones were banned, so no live-tweeting. All for a hearing at which one hand-picked judge could severely curtail access to abortion for millions of women across the country, based on vibes. I really hope I’m wrong, but I don’t see anything in the coverage I’ve read to suggest this guy will do anything other than what he clearly wants to do. We’ll find out soon. Jezebel, the Associated Press, Slate, Daily Kos, and NBC News have more.

UPDATE: From Slate, “If Kacsmaryk rewrites the history of mifepristone’s approval as grounds to pull it from the market, his decision should command no respect or acquiescence from anyone—not the FDA, not abortion providers, and certainly not the public at large.”

Like I said, brace yourselves.

A federal judge in Texas will hear arguments Wednesday in a closely watched dispute that could halt distribution of a key drug used for medication abortion and disrupt access nationwide, even in states where reproductive rights are protected.

The case before U.S. District Judge Matthew Kacsmaryk was brought in November by a conservative legal organization on behalf of anti-abortion rights medical associations and targets the Food and Drug Administration’s (FDA) decades-old approval of the drug mifepristone, one of two medications used to terminate an early pregnancy.

The associations have requested Kacsmaryk order the FDA to withdraw its 2000 approval of mifepristone, arguing the agency erred when it gave the green-light to the drug under a regulation that allows accelerated approval of medications for “serious or life-threatening illnesses.”

But the Biden administration has warned that such a step would harm patients who rely on abortion pills and further strain state health care systems, particularly in places with clinics already grappling with overcrowding as a result of abortion restrictions in neighboring states.

The parties will have two hours apiece to press their arguments before Kacsmaryk, and the judge laid out a host of issues for them to discuss Wednesday, including whether the associations have the legal standing to sue, whether an injunction would serve the public interest and the regulation under which mifepristone was approved.

Kacsmaryk could issue his decision on the associations’ request for a preliminary injunction any time after the hearing, though a quick appeal to the U.S. Circuit Court of Appeals for the 5th Circuit is expected.

[…]

In papers filed with the court, the anti-abortion rights groups claimed the FDA exceeded its regulatory authority to approve mifepristone and has over the years removed safeguards by changing the dosage and route of administration in 2016, and lifting an in-person dispensing requirement to allow the pills to be mailed in 2021.

“The FDA took these actions by running roughshod over the laws and regulations that govern the agency and, more importantly, protect the public from harmful drugs,” they argued.

The Biden administration countered that the challengers’ request for the court to withdraw approval of mifepristone is “extraordinary and unprecedented.” Administration lawyers said they have been unable to find any case where a court has “second-guessed FDA’s safety and efficacy determination and ordered a widely available FDA-approved drug to be removed from the market — much less an example that includes a two-decade delay.”

Taking aim at the associations’ claim that the FDA improperly accelerated approval of mifepristone without substantial evidence of its safety, Justice Department lawyers noted that the 2000 approval of the drug came more than four years after manufacturer Danco submitted its application.

The drug maker, too, told the court that forcing the FDA to withdraw its long standing approval of mifepristone would not only “seismically disrupt the agency’s governing authority as to whether drugs are safe and effective,” but also put Danco out of business.

“The public has no interest in a hastily cobbled together, and overtly political, attempt by private parties to wrest control of the drug approval process from the United States agency responsible for it — an agency that has acted deliberately, thoughtfully, and consistent with its authorizing statute and implementing regulations,” the company said.

See here for the background. Plenty of legal types have written at length about how specious and flimsy the plaintiffs’ arguments are, and how utterly lacking their claim of standing is, so I’ll just note that and move on. Whether any of that matters to this wingnut judge or not will only be known after his ruling. As for the coverage of this ridiculous lawsuit, TPM among others provided insight:

TPM has obtained, and is first to report, the transcript from the status conference, which was conducted over the phone.

The case centers on the Food and Drug Administration’s 20-year-old approval of mifepristone, a drug often prescribed with misoprostol to induce abortions. Anti-abortion groups are trying to get that approval revoked, which could send the drug’s availability into flux.

After some typical housekeeping, Kacsmaryk leans on the lawyers to keep the hearing quiet.

“Because of limited security resources and staffing, I will ask that the parties avoid further publicizing the date of the hearing,” he said. “This is not a gag order but just a request for courtesy given the death threats and harassing phone calls and voicemails that this division has received. We want a fluid hearing with all parties being heard. I think less advertisement of this hearing is better.”

He said that the case so far has brought “a barrage of death threats and protesters and the rest.”

“So we will have standard security protocols in place, but I’ll just ask as a courtesy that you not further advertise or Tweet any of the details of this hearing so that all parties can be heard and we don’t have any unnecessary circus-like atmosphere of what should be more of an appellate-style proceeding,” he added.

He then told the lawyers that he was going to purposefully keep the hearing off the docket until the day before the hearing, to keep it as under the radar as possible — a move that prompted questions and objections by observers when discovered. A Department of Justice lawyer on the call sought clarification about whether the hearing would be made public at some point Tuesday.

“To minimize some of the unnecessary death threats and voicemails and harassment that this division has received from the start of the case, we’re going to post that later in the day,” Kacsmaryk replied. “So it may even be after business hours, but that will be publicly filed.”

The absolute best case scenario here is that in the end this was all a massive waste of time and energy. Here’s hoping. CNN, ABC News, and CNBC have more.

Nothing about this is good.

The Texas judge who could undo government approval of a key abortion drug has scheduled the first hearing in the case for Wednesday but took unusual steps to keep it from being publicized, according to people familiar with the plans.

The hearing will be an opportunity for lawyers for the Justice Department, the company that makes the drug and the conservative group that is challenging it to argue their positions before U.S. District Court Judge Matthew Kacsmaryk. After they do, the judge could rule at any time.

Kacsmaryk scheduled the hearing during a call with attorneys Friday, said multiple people familiar with the call, who spoke on the condition of anonymity because they were not authorized to discuss it. Kacsmaryk said he would delay putting the hearing on the public docket until late Tuesday to try to minimize disruptions and possible protests, and asked the lawyers on the call not to share information about it before then, the people said.

Public access to federal court proceedings is a key principle of the American judicial system, and Kacsmaryk’s apparent delay in placing the hearing on the docket is highly unusual. The judge and his staff did not respond to emails requesting comment on Saturday evening.

The lawsuit seeks to revoke Food and Drug Administration approval of mifepristone, one of two drugs used in a medication abortion. The case has garnered widespread attention and protests.

A decision by Kacsmaryk to suspend FDA approval of mifepristone would immediately prompt major changes in how many abortion clinics across the country provide care. Some are planning to immediately switch to a misoprostol-only protocol, while others are planning to offer only surgical abortions. Any decision would likely be appealed to the conservative U.S. Court of Appeals for the 5th Circuit, and possibly to the Supreme Court.

[…]

Kacsmaryk told the attorneys that he also wanted to delay publicizing the hearing because courthouse members have received threats in the wake of the lawsuit, according to the people familiar with the call. Several people close to Kacsmaryk say the judge and his family have faced security threats since he ascended to the federal bench in 2019, and those threats have intensified ahead of the abortion pill ruling.

Before and after the Friday phone call with lawyers, The Washington Post repeatedly called and emailed Kacsmaryk’s chambers seeking information about it, but received no response. Kacsmaryk’s chambers also did not respond to a request that reporters be allowed to join the call.

Kacsmaryk was nominated by President Donald Trump and is known for his conservative views on issues like same-sex marriage and abortion.

By waiting to publicize the time of the hearing, Kacsmaryk and his staff could make it difficult for the public, the media and others to travel to the courthouse in Amarillo. The remote, deeply conservative city has few direct flights except from Dallas or San Antonio and is at least a four-hour drive from any of the state’s major, heavily-Democratic cities. Still, over 150 abortion rights advocates gathered there on a Saturday in mid-February to voice their support for abortion pills.

I noted this lawsuit when it was filed. There’s been a metric crap-ton of analysis and punditry and increasingly dire warnings about this lawsuit and the pernicious effect of court-shopping, and I’ll leave it to you to google around for all the screaming into the void you can handle. It’s possible that this maneuver means that Kacsmaryk has at least a dim idea that his actions have the potential to cause a massive shitstorm. It also may just be that he doesn’t care to deal with the media and he has the power to make his wishes come true. Either way, brace yourselves.

UPDATE: Chris Geidner has more.