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The first hearing in a lawsuit that seeks to overturn F.D.A. approval of the pills takes place Wednesday morning in Texas.
AMARILLO, Texas — A hearing Wednesday in a lawsuit that seeks to overturn federal approval of a widely used abortion pill will provide the first opportunity to hear the arguments of the anti-abortion groups that filed the lawsuit and of the Food and Drug Administration, which is fighting to keep the abortion pill legal.
The lawsuit, which seeks to end more than 20 years of legal use of medications for abortion, could have widespread implications in states where abortion is legal, not just where it is illegal. Medication abortion is used in more than half of pregnancy terminations in the United States and 40 percent of clinics that provide abortion services offer abortion pills only, not the surgical procedure.
The hearing on Wednesday will revolve around the plaintiffs’ request that Judge Matthew J. Kacsmaryk of the Northern District in Texas 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.
Judge Kacsmaryk, a Trump appointee who has written critically about Roe v. Wade and previously worked for a Christian conservative legal organization, took some unusual steps leading up to the hearing. In a meeting last Friday with lawyers for the parties in the case, he asked them to keep quiet about the fact that a hearing had been scheduled and told them he planned to delay making the public aware of it and would only enter it into the public court record the evening before.
In a transcript of the Friday meeting obtained by The New York Times, Judge Kacsmaryk said that other aspects of the case have “brought a barrage of death threats and protesters and the rest” and that he wanted to avoid an “unnecessary circus-like atmosphere” that might disrupt the lawyers’ presentations in court.
Despite the judge’s request, news organizations learned about the hearing and reported it. Members of groups that support abortion rights are planning to demonstrate outside the court building while the hearing is in progress, including by wearing kangaroo and judge costumes to protest what they consider to be a “kangaroo court” and by driving a truck around the city streets with a billboard that will say “a majority of Americans support abortion access.”
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, which is representing the F.D.A., have strongly disputed those claims, saying the F.D.A.’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.
It is unclear if the judge will rule at the end of the session Wednesday. Most legal experts expect that he will make his decision at a later date.
Here are some of the issues that the judge has asked lawyers to be prepared to discuss at the hearing:
Whether the plaintiffs have legal standing to bring the lawsuit
The plaintiffs are led by the Alliance for Hippocratic Medicine, an organization that lists five anti-abortion groups as its members. Shortly after the Supreme Court overturned Roe v. Wade, the alliance was incorporated in August in Amarillo, where Judge Kacsmaryk is the only federal judge.
The five groups are not based in Amarillo, but Erik Baptist, senior counsel for the Alliance Defending Freedom, a conservative Christian legal advocacy group that is representing the plaintiffs, said that some of the groups’ members are in the Amarillo area, as is one of the four doctors who are plaintiffs in the case.
The plaintiffs contend they have legal standing to sue as parties who experienced injury from the F.D.A. approval because they have treated women who they say have suffered harm from abortion pills. Legal experts, including some conservative legal scholars, said it might be difficult to support a claim that the plaintiffs have standing because the harm they are claiming could be considered several steps removed from the F.D.A.’s approving the drug. The intermediate steps include patients choosing to take the drug and then seeking medical care.
If the judge were to decide that the plaintiffs do not have legal standing to sue, then the case could not proceed.
Whether this lawsuit is an appropriate legal challenge to the F.D.A.’s authority
The judge has indicated that he expects the parties to discuss issues related to the F.D.A.’s authority to approve and regulate drugs. Some legal experts have pointed to constitutional provisions and Congressional actions that suggest that the F.D.A. has overarching authority that cannot be second-guessed by a court. Legal experts say that if the judge were to rule for the plaintiffs, it would apparently be the first time a court had acted to order that a drug be removed from the market over the objection of the F.D.A.
The F.D.A. has also said in its filing in the case that there is a six-year statute of limitations to challenge the agency’s actions and that the plaintiffs are bringing this lawsuit much too late.
The plaintiffs argue that their lawsuit is an appropriate legal action.
Did the F.D.A. err in approving mifepristone under the regulation used at the time?
Mifepristone was initially approved in 2000 under a set of regulations called “Subpart H,” which was created to expedite the approval of drugs “that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses.”
The lawsuit alleges that mifepristone did not qualify for this type of approval because the plaintiffs say that “pregnancy is not an illness.”
The approval process for mifepristone was not expedited — it took over four years — but the F.D.A. applied Subpart H, which allowed the agency to impose additional restrictions on use of the drug, including requiring health care providers to have special qualifications to prescribe it and dispense it only in certain medical settings.
The F.D.A. argues that “illness” is a term that generally applies to medical conditions, not only to diseases. The agency says that any confusion in semantics was cleared up several years later when Congress created a new regulatory framework that used the term “disease or condition.”
Are abortion medications unsafe?
The plaintiffs claim that the pills, which they call “chemical abortion,” cause “cramping, heavy bleeding and severe pain” and that the F.D.A. has never adequately evaluated the scientific evidence for safety.
The F.D.A. vigorously disputes this claim, as do mainstream medical organizations. They say that bleeding and cramping are normal consequences of the process, a sign that the pregnancy tissue is being expelled, and cite years of scientific studies that show that serious complications are rare. The organizations note that mifepristone has actually been regulated much more strictly and studied more intensively than most other drugs.
For a dozen years, the F.D.A. has imposed on mifepristone an additional framework of restrictions and monitoring called a Risk Evaluation and Mitigation Strategy, or REMS. It is a framework that has been used for only about 300 other drugs. In recent years, the F.D.A. has extensively reviewed new data on mifepristone and concluded that the drug was safe enough to lift several of the restrictions, including the requirement that patients obtain the drug in person from a provider.