by AMARILLO, Texas (AP) — A federal judge on Wednesday will hear arguments in a high-stakes court case that could jeopardize access to medical abortion and weaken the authority of U.S. drug regulators.
Texas Judge Matthew Kacsmaryk is considering a lawsuit brought by Christian conservatives seeking to overturn the more than two-decade-old Food and Drug Administration approval of the abortion pill mifepristone. The drug, when used with a second pill, has become the most common abortion method in the United States
There is essentially no precedent for a single judge overruling the FDA’s scientific decisions. And legal experts have warned of far-reaching consequences if judges begin to question FDA decisions on drug safety and efficacy.
Wednesday’s hearing is the first in the case brought by groups on both sides of the abortion issue following the Roe v. Wade has been closely followed over the last year. But there was little advance notice of the high-profile session, which only appeared on the public online listing late Monday after news reports raised concerns about a lack of transparency in the proceedings.
Kacsmaryk told attorneys in the case Friday that he would delay filing to minimize threats and possible protests, a development first reported by The Washington Post. He also urged lawyers not to disclose the date of the hearing, according to a transcript of the meeting released Tuesday.
Such actions by a judge are highly unusual given that court hearings are almost always open to the public and transparency is a fundamental requirement of the American justice system.
Appointed by President Donald Trump, Kacsmaryk used to work as an attorney for a Christian rights group and has written critically of laws allowing abortion. Abortion advocates say conservatives bring cases to his courtroom because they believe he will rule in their favor.
On Wednesday in Amarillo, Kacsmaryk will hear arguments from the Alliance for Defending Freedom — which filed its lawsuit on behalf of several anti-abortion groups and doctors — and federal prosecutors representing the FDA. The drug’s maker, Danco Laboratories, is also involved in the case and will work to ensure its pill remains available.
The alliance is seeking an injunction that would force the FDA to revoke its approval of mifepristone. But it’s unclear how quickly that could happen or what the process would entail. The FDA has its own procedures for revoking drug approvals, which involve public hearings and scientific deliberations that can take months or years.
If Kacsmaryk rules against the FDA, federal prosecutors are expected to quickly appeal the decision and seek an emergency stay to prevent it from taking effect while the case moves forward.
Mifepristone is part of a two-drug regimen that has been the standard for medical abortions in the US since 2000. If mifepristone is set aside, clinics and doctors prescribing the combination say they plan to use only the second drug, misoprostol. This single-drug approach is slightly less effective at terminating pregnancies, although it is widely used in countries where mifepristone is illegal or unavailable.
The Texas lawsuit alleges that the FDA’s 2000 approval of mifepristone was flawed for a number of reasons, including insufficient review of the pill’s safety risks. The lawsuit also challenges several subsequent FDA decisions that relaxed restrictions on the pill, including removing the requirement for women to pick them up in person.
FDA advocates have cautioned that serious side effects from mifepristone are rare, and the agency has repeatedly affirmed the drug’s safety by reviewing subsequent studies and data. Discontinuing the drug more than 20 years after approval would be “extraordinary and unprecedented,” the government said in its legal response.
Typically, the FDA’s authority to regulate prescription drugs has gone unchallenged. But more than a dozen states now have laws restricting abortion in general — and the pill in particular — following last year’s Supreme Court decision that ruled Roe v. Wade was lifted.
Lawsuits against state restrictions, including those in North Carolina and West Virginia, are progressing separately and are expected to continue for years.
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Perrone reported from Washington.
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