Texas judge hears case to end federal approval of abortion pill
AMARILLO, Texas — The first hearing in a closely watched lawsuit aimed at overturning federal approval of a widely used abortion pill ended Wednesday without a verdict, after more than four hours of well-aimed and insistent arguments by both sides.
Lawyers for the anti-abortion groups and doctors who filed the lawsuit claimed that the abortion pill was unsafe and that the Food and Drug Administration made mistakes in approving it.
Attorneys for the Department of Justice, which represents the FDA, cited evidence that the drug mifepristone was extremely safe, alleging that the plaintiffs did not even have legal authority to file the lawsuit because none of them could show the FDA had approved them damage inflicted.
Federal Judge Matthew J. Kacsmaryk of the Northern District of Texas, a Trump agent critical of Roe v. Wade said he would make a decision on whether to issue a restraining order as soon as possible. He asked both sides calm and detailed questions about the matter, and also asked if he had the authority to order the FDA to withdraw or temporarily suspend its approval until the entire case could be heard.
The hearing was the first public hearing in a case that could have far-reaching ramifications for states where abortion is still legal, not just those trying to restrict it.
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Since last year’s Supreme Court ruling overturning the national right to abortion, the pills used in medical abortions have increasingly become the focus of political and legal disputes. Medicated abortion is the method used in more than half of abortions in the United States. In states where abortion is banned or severely restricted, women continue to order the pills abroad or travel to other states to get them.
The hearing focused on a request by plaintiffs, a coalition of anti-abortion groups, to Judge Kacsmaryk for an injunction directing the FDA to withdraw its long-standing approval of mifepristone — the first pill in the dual-drug abortion regimen – while the case goes to court.
Judge Kacsmaryk said he wanted to avoid an “unnecessary circus-like atmosphere” and had asked the lawyers in the case last week not to disclose that the hearing had been scheduled and he had planned to wait until Tuesday night to add it to the court record . After news organizations nevertheless found out about the session and reported on it on Sunday, the judge published an announcement of the hearing on Monday.
A few pro-choice advocates went on strike outside the courthouse throughout the day, some mocking the judge by wearing clown wigs and kangaroo suits. A group of women supporting the lawsuit prayed on the courtroom steps. There were no large gatherings of people.
The lawsuit aims to end more than 20 years of legal use of mifepristone, which the FDA approved in 2000, and ban the use of another drug commonly used for abortions, misoprostol.
The lawsuit alleges that the FDA failed to adequately review the scientific evidence or follow proper protocols when it approved mifepristone in 2000, and that it has since ignored the drug’s safety risks.
The FDA and the Department of Justice have strongly denied these claims. They claim that the federal agency’s rigorous reviews of mifepristone over the years have repeatedly validated their decision to allow mifepristone, which blocks a hormone that allows pregnancy to develop. In a court filing in the case, the FDA said that reversing mifepristone’s approval would cause “significant harm and deprive patients of a safe and effective drug that has been on the market for more than two decades.”
The case was brought by the Alliance for Hippocratic Medicine, an organization that lists five anti-abortion groups as its members and four individual doctors opposed to abortion rights. The group was formed in Amarillo, Texas, in August, shortly after the Supreme Court ruled Roe v. Wade had fallen. The case was assigned to Judge Kacsmaryk, the only judge in the Northern District of Texas serving the Amarillo division. Prior to his appointment by President Trump, Judge Kacsmaryk wrote an article that supported Roe v. Wade, as well as issues such as marriage equality and federal antidiscrimination protections for sexual orientation and gender identity.
The case has raised a lot of concern in the reproductive health community, in part because of confusion over what options would be available to patients if the judge ruled for the anti-abortion groups. Some abortion providers have made plans to provide only the second abortion drug, misoprostol, which is safe to use alone in many countries where mifepristone is less available.
Misoprostol, a drug approved for other medical uses, causes miscarriage-like contractions and is thought to be slightly less effective on its own than in combination with mifepristone, and more prone to side effects such as nausea.
The FDA has regulated mifepristone more tightly than many other drugs. For a dozen years, the agency has imposed an additional framework of restrictions and oversight on the drug. It’s called the Risk Evaluation and Mitigation Strategy, or REMS, and has only been used for about 300 other drugs, of which only 60 are currently active under the framework.
In recent years, the FDA has extensively reviewed new data on mifepristone and lifted several of the restrictions, including requiring patients to receive the drug in person from a vendor.
Some of the same anti-abortion organizations that filed the Texas lawsuit had previously filed citizen petitions against the FDA’s actions on mifepristone in 2002 and 2019. Both were rejected by the agency as unfounded. And a 2008 review by the Government Accountability Office found no irregularities in the FDA’s approval of mifepristone.
Lucinda Holt provided reporting from Amarillo.