By Tyler Arnold
Washington, D.C. Newsroom, Mar 26, 2024 / 15:45 pm
United States Supreme Court justices on Tuesday pressed the Food and Drug Administration (FDA) on the safety of the abortion pill mifepristone but appeared skeptical that a pro-life doctor’s group challenging the agency had any legal standing to sue.
The justices heard oral arguments on March 26 for a lawsuit brought by the Alliance for Hippocratic Medicine (AHM), which seeks to impose more restrictions on the prescription of mifepristone. The drug is approved to chemically abort a child up to 10 weeks into the mother’s pregnancy.
AHM, which represents pro-life medical groups, sued the FDA in November 2022 to challenge the agency’s approval of mifepristone. The lawsuit further challenged the FDA’s subsequent deregulation of the drug, particularly its permission to prescribe the medicine without an in-person doctor’s visit and to dispense the drug through the mail.
FDA questioned on abortion pill’s safety
During oral arguments, the court’s more conservative justices questioned the FDA’s lawyer, U.S. Solicitor General Elizabeth B. Prelogar, on whether the FDA followed proper protocol when deregulating mifepristone.
This Supreme Court case is the most-watched abortion-related decision since the court overturned Roe v. Wade, which allowed states to impose restrictions on abortion. Six justices voted to overturn the precedent: Clarence Thomas, Samuel Alito, Amy Coney Barrett, John Roberts, Brett Kavanaugh, and Neil Gorsuch.
Barrett, who was appointed by former President Donald Trump, expressed concern that ending the in-person requirement could “lead to mistakes in gestational aging” because doctors would not be able to perform an ultrasound. She asked whether this “could increase the need for a [dilatation and curettage procedure or increase] the amount of bleeding.”
Alito questioned why the agency only studied the effects of the deregulatory actions individually rather than studying how they could pose a safety risk when taken together as a whole.
In defending the FDA’s decisions, Prelogar told the justices that the FDA “demonstrated that these changes … were safe” through its analysis of studies and that the deregulation being safe was not reliant on “other different safeguards in place.” She also noted that ultrasounds had never been required by the FDA.
“I don’t think you can fault the agency for not giving even more explicit attention to this issue,” she said.
Prelogar said the FDA found that some studies suggested the deregulation would increase emergency room visits but found no evidence that it would increase adverse effects. She said the “FDA’s actions were lawful” and that AHM “just disagree[s] with the agency’s analysis of the data before it.”
“That’s a question that Congress has entrusted to the FDA,” Prelogar said.
Jessica Ellsworth, a lawyer representing mifepristone provider Danco Laboratories, similarly expressed concern about courts assuming the authority to determine how the FDA handles its protocol related to studying the safety of drugs and deregulation.
“Courts are just not in a position to parse through [the studies] and second guess [the FDA’s conclusion],” Ellsworth said.
Erin Hawley, a lawyer for Alliance Defending Freedom (ADF), which is representing AHM, later countered the arguments from the FDA and Danco, saying that in-person visits would increase the likelihood of the woman receiving an ultrasound before being prescribed the drugs, rather than “to be able to order these online with a couple of screening questions.”
Does AHM have legal standing to sue?
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When Hawley was questioned about the lawsuit, the justices focused heavily on whether AHM had any legal standing to sue the FDA.
Hawley argued that her clients, some of whom are emergency room doctors, have standing to sue because they are forced to care for women suffering from complications with the abortion pill, even if the doctors object to abortion.
“[They are] forced to manage abortion drugs’ harm,” she said.
Although federal law allows doctors to refrain from providing services that violate the doctor’s conscience, Hawley claimed that objections in these situations are not practical because of the “emergency nature of these procedures.”
Hawley said the lack of in-person care leads to inadequate follow-ups for the women who use the drug, which leads them to seek care in emergency rooms.
“[The FDA’s deregulations] turn emergency rooms into that follow-up visit,” Hawley said.
Justice Ketanji Brown Jackson, who was appointed by President Joe Biden, said that federal law already protects their right to object and questioned why the court would need to impose “an order preventing anyone from having access to these drugs at all” to remedy these concerns.
During the conversation, Trump-appointed Justice Neil Gorsuch similarly expressed concern about a district court’s ability to restrict access to a drug nationwide based on the legal objections from a handful of doctors.
Both Alito and Thomas pressed the FDA’s lawyer on who would be allowed to sue the FDA in this situation if not AHM. Prelogar said it would be hard to identify any person or group who would have the legal standing to file a lawsuit.
The Supreme Court is expected to decide the case by June.
