A federal district court in Texas will hear a challenge to the federal government’s approval of a common medication abortion drug on Wednesday, leaving an opening for a lone judge to issue a preliminary injunction that could withdraw or suspend the drug’s approval nationwide while the lawsuit plays out.
The case surrounds a challenge brought by anti-abortion physicians and medical associations to the Food and Drug Association’s 2000 approval of the drug mifepristone, the first drug in the medication abortion process.
TEXAS JUDGE TRIES TO AVOID PROTESTS AT HEARING FOR ABORTION PILL LAWSUIT: REPORTS
If the judge grants the request to block access to the drug nationwide, it could make the abortion pills more difficult to obtain even in states where such procedures are legal. The Biden administration is likely to appeal any decision against abortion drugs swiftly.
Here are four things to know about the hearing in the case, Alliance for Hippocratic Medicine v. FDA, beginning at 10 a.m. Eastern time on Wednesday:
Limited access to arguments in the hearing
The case will be heard by U.S. District Judge Matthew Kacsmaryk, whose courtroom is in Amarillo, Texas, a remote division in the northern panhandle of Texas that is distant from many major cities. However, the hearing is slated to be open to the public.
Only lawyers will be allowed to bring in electronic devices to the Wednesday hearing, a common practice in high-profile court cases and there will not be an online broadcast of the hearing.
The only location to listen to the hearing outside the Amarillo courtroom will be at the Dallas Division of the Northern District of Texas, according to a notice issued Tuesday afternoon.
What the challengers of mifepristone FDA approval say
Several medical associations, including the American Association of Pro-Life Obstetricians and Gynecologists and the Alliance for Hippocratic Medicine, as well as four doctors, are arguing in the lawsuit that the FDA went beyond its regulatory authority in approving mifepristone in 2000. The FDA told the Washington Examiner that it does not comment on pending litigation.
Legal experts contend there is little precedent for what the plaintiffs are seeking in the district court and that the immediate effects on the availability of mifepristone would hinge on the substance of the judge’s decision.
David Cohen, a law professor at Drexel University’s Thomas R. Kline School of Law, previously said the impact of the judge’s decision could be minimal compared to the fears expressed by defenders of the drug.
“His order could say that mifepristone was improperly approved and just limit it to applying in Texas or wherever he has jurisdiction,” Cohen told the Washington Examiner.
Government calls challenge to FDA approval ‘unprecedented’
Attorneys for the Biden administration argued in January court filings that the challenge to the 2000 FDA approval of mifepristone is “unprecedented.”
Government lawyers say overturning the FDA approval of the abortion pill would result in it being pulled from the market, adding that it would harm the public interest.
“If longstanding FDA drug approvals were so easily enjoined, even decades after being issued, pharmaceutical companies would be unable to confidently rely on FDA approval decisions to develop the pharmaceutical-drug infrastructure that Americans depend on to treat a variety of health conditions,” Biden administration lawyers wrote.
Judge has history of disagreeing with the Biden administration
Kacsmaryk, an appointee of former President Donald Trump, twice ruled against the Biden administration’s efforts to terminate the Migrant Protection Protocols, a policy instituted by the former president to keep asylum-seekers from south of the border in wait on the Mexican side until their claims are either granted or denied.
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And last November, the judge ruled against the Biden administration’s reinterpretation of the word “sex” to include “sexual orientation” and “gender identity” in federal statutes, a move that was touted by conservative advocacy groups as a victory for healthcare workers who argued they were forced to provide transgender medical procedures against their sincere beliefs.
Critics of the judge have also pointed to his background as a former deputy general counsel to the First Liberty Institute, a firm that has represented a multitude of Christian plaintiffs in First Amendment cases all the way up to the Supreme Court.
Abigail Adcox contributed to this report.
