Like I said, brace yourselves.
A federal judge in Texas will hear arguments Wednesday in athat 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 beforewas 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.”