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Health and legal experts: Ruling overturning FDA approval for abortion pill is a worrisome first

Published: Monday, April 10, 2023 - 6:05pm
Updated: Tuesday, April 11, 2023 - 9:02am

On Friday, a Texas judge ruled to overturn the FDA’s approval of mifepristone — a drug that has been widely used over the last 20 years to induce an abortion within 10 weeks of pregnancy. Legal and public health experts say it's the first ruling of its kind and is likely headed for the U.S. Supreme Court, but it could have broader impacts for other medications. 

On a call with reporters Monday, Dr. Lynn Goldman, a physician, epidemiologist and the Dean of George Washington University's Milken Institute School of Public Health, said physicians rely on FDA approval to trust the medications they give to patients. 

"And those decisions, for us to trust the consequences of that review, need to be made by scientific experts who understand those data, and can best evaluate them. And those experts are not judges and they are not courts of law," she said.

In his ruling, Judge Matthew Kacsmaryk said the FDA had violated its statutory duty by approving the drug and ignoring what he called "legitimate safety concerns."

Goldman said the drug is a safe way to end a pregnancy, but said she worried the ruling could be a gateway to restrict other drugs —  like some rheumatoid arthritis medications — that can be used to induce abortions but are intended to treat other conditions.

The Justice Department us appealing Kacsmaryk's ruling and the case is now on hold for a week. 

Williams Shultz, a former deputy FDA commissioner who also served as general counsel to Health and Human Services, told reporters the agency’s mandate from Congress is to evaluate the safety and effectiveness of a drug.

"Basically to determine whether the benefits of the drug outweigh the risk. This is a complex decision involving medicine, statistics, and sometimes epidemiology," he said on the call.

Shultz said this is the first time a court has overturned a drug’s FDA approval on the grounds that the agency’s assessment was wrong. 

On Monday, Attorney General Kris Mayes announced Arizona was joining a coalition of 24 states filing suit against the order.

Fronteras Abortion