Lawyers Spar Before Judge Over Rescinding Federal Approval of Abortion Pill
AMARILLO, Texas — The first hearing in a closely watched lawsuit seeking to overturn federal approval of a widely used abortion pill concluded Wednesday without a ruling, after more than four hours of pointed and emphatic arguments by both sides.
Lawyers for the anti-abortion groups and physicians who had filed the suit claimed that the abortion pill was unsafe and that the Food and Drug Administration had made mistakes in approving it.
Lawyers from the Department of Justice, which is representing the F.D.A., cited evidence that the medication, mifepristone, was extremely safe, and contended that the plaintiffs did not have any legal standing to even file the lawsuit because none of them could show that the F.D.A. approval had caused them harm.
The federal judge, Matthew J. Kacsmaryk of the Northern District of Texas, a Trump appointee who has written critically about Roe v. Wade, said he would make a decision about whether to issue an injunction as soon as possible. He asked both sides calm and detailed questions about the facts and also asked them about whether he had the authority to order the F.D.A. to withdraw or temporarily suspend its approval until the full case could be heard.
The hearing was the first public session in a case that could have far-reaching consequences for states where abortion is still legal, not just for 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 medication abortions have increasingly become the focus of political and legal battles. Abortion by medication is the method used in more than half of abortions in the United States. In states where abortion has been banned or severely restricted, women continue to order the pills from overseas or to travel to other states to get them.
The focus of the hearing was a request by the plaintiffs, a coalition of anti-abortion groups, for Judge Kacsmaryk to grant a preliminary injunction ordering the F.D.A. to withdraw its longstanding approval of mifepristone — the first pill in the two-drug medication abortion regimen — while the case proceeds through trial.
Saying he wanted to avoid an “unnecessary circus-like atmosphere,” Judge Kacsmaryk had last week asked the lawyers in the case not to disclose that the hearing had been scheduled and he had planned to wait until Tuesday evening to list it on the court docket. After news organizations learned of the session anyway and reported it on Sunday, the judge posted an announcement of the hearing on Monday.
A smattering of abortion rights supporters picketed the courthouse throughout the day, some mocking the judge by wearing clown wigs and a kangaroo suit. A group of women supporting the lawsuit prayed on the courtroom steps. No large crowds materialized.
The lawsuit seeks to end more than 20 years of legal use of mifepristone, which the F.D.A. approved in 2000, and to outlaw use of another drug commonly used for abortion, misoprostol.
The lawsuit claims that the F.D.A. did not adequately review the scientific evidence or follow proper protocols when it approved mifepristone in 2000 and that it has since ignored safety risks of the medication.
The F.D.A. and the Department of Justice have strongly disputed those claims. They contend that the federal agency’s rigorous reviews of mifepristone over the years had repeatedly reaffirmed its decision to approve mifepristone, which blocks a hormone that allows a pregnancy to develop. In a court filing in the case, the F.D.A. said that overturning its approval of mifepristone would “cause significant harm, depriving patients of a safe and effective drug that has been on the market for more than two decades.”
The case was filed by the Alliance for Hippocratic Medicine, an organization that lists five anti-abortion groups as its members, and four individual doctors who are against abortion rights. The group incorporated in Amarillo, Tex., in August, shortly after the Supreme Court overturned Roe v. Wade. The case was assigned to Judge Kacsmaryk, the only judge in the Northern District of Texas who covers the Amarillo division. Before his appointment, by President Trump, Judge Kacsmaryk wrote an article that was critical of Roe v. Wade, as well as issues like marriage equality and federal anti-discrimination protections for sexual orientation and gender identity.
The case has caused a frenzy of concern in the reproductive health community, in part because of confusion about what options would be available to patients if the judge ruled for the anti-abortion groups. Some abortion providers have been making plans to provide only the second abortion medication, misoprostol, which is used safely on its own in many countries where mifepristone is less available.
Misoprostol, a drug that is approved for other medical uses, causes contractions similar to a miscarriage and is considered slightly less effective on its own than in combination with mifepristone and more prone to cause side effects like nausea.
The F.D.A. has regulated mifepristone more stringently than many other drugs. For a dozen years, the agency has imposed an additional framework of restrictions and monitoring for the drug. Called a Risk Evaluation and Mitigation Strategy, or REMS, it has been used for only about 300 other drugs, only 60 of which are currently actively under the framework.
In recent years, the F.D.A. has extensively reviewed new data on mifepristone and has lifted several of the restrictions, including the requirement that patients obtain the drug in person from a provider.
Some of the same anti-abortion organizations that filed the Texas lawsuit had previously filed, in 2002 and 2019, citizen petitions opposing the F.D.A.’s actions on mifepristone. Both were rejected by the agency as unfounded. And a 2008 review by the Government Accountability Office found no irregularities with the F.D.A.’s mifepristone approval.
Lucinda Holt contributed reporting from Amarillo.
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