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At stake in mifepristone case: Abortion, FDA's authority and return to 1873 obscenity law

Sarah Varney, KFF Health News on

Published in Political News

The Biden administration and a manufacturer of mifepristone, Danco Laboratories, have argued in legal filings to the Supreme Court that federal judges do not have the scientific and health expertise to evaluate drug safety and that allowing them to do so undermines the FDA’s regulatory authority.

That view is supported by food and drug legal scholars who wrote in court filings that the lower courts had replaced the “FDA’s scientific and medical expertise with the courts’ own interpretations of the scientific evidence.” In doing so, they wrote, the courts “upend the drug regulatory scheme established by Congress and implemented by FDA.”

In his ruling, Kacsmaryk cited two studies purporting to show an increase in emergency room visits and a greater risk of hospitalizations from medication abortion. They were retracted in February by medical publisher Sage Perspectives. The journal said the researchers erred in their methodology and analysis of the data and invalidated the papers “in whole or in part.”

The research, supported by the Charlotte Lozier Institute, an anti-abortion group that filed a brief in the mifepristone case, “made claims that were not supported by the data,” said Ushma Upadhyay, a professor of reproductive sciences at the University of California, San Francisco.

Legal scholars say the Supreme Court’s conservative justices have demonstrated a willingness to accept discredited abortion-related health claims. Justice Samuel Alito, writing the majority opinion in Dobbs v. Jackson Women’s Health Organization, which overturned the constitutional right to abortion, cited statements about harm to maternal health presented by the state of Mississippi that contradict mainstream medical consensus.

“If this case is successful, it will be because the Supreme Court decided to ignore evidence that demonstrated mifepristone’s safety and said to a federal agency, the expert on drug safety, ‘You were wrong,’” said Rachel Rebouché, dean of Temple University Beasley School of Law.

 

The mifepristone case crystallizes “the politicization of science” in abortion regulation, Rebouché said. “But the stakes are getting higher as we have courts willing to strip federal agencies of their ability to make expert decisions.”

Rebouché said that if the Supreme Court overrides the FDA’s expertise in regulating a 24-year-old drug like mifepristone, anti-abortion groups, like Students for Life of America, could find judges receptive to false claims that birth control pills, intrauterine devices, emergency contraception, and other forms of hormonal birth control cause abortion. They do not, according to reproductive scientists and U.S. and international regulatory agencies.

Justice Clarence Thomas wrote in his concurring opinion in Dobbs that the Supreme Court should reconsider the 1965 decision that guaranteed a constitutional right to contraception, Griswold v. Connecticut, and decide whether to return the power to allow or regulate access to birth control to the states.

Tucked into the Alliance Defending Freedom’s filings is what scholars describe as an audacious legal strategy once on the fringes of the conservative Christian movement: an appeal to the Supreme Court’s conservative members to determine that the Comstock Act, a dormant 1873 anti-vice law, effectively bans medical and procedural abortion nationwide.

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©2024 Kaiser Health News. Visit khn.org. Distributed by Tribune Content Agency, LLC.

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