NPR: https://www.npr.org/2023/04/21/1170742958/u-s-supreme-court-blocks-lower-court-decision-in-fda-approval-of-abortion-pill-c
Health

The Supreme Court doesn’t let abortion pill access be stopped

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The Supreme Court’s ruling on the nationwide prohibition of mifepristone: “The case against illegal abortion” is now before the next court of appeals

The latest legal clash over abortion began April 7 in Texas when U.S. District Judge Matthew Kacsmaryk, a onetime anti-abortion activist, imposed a nationwide ban on mifepristone, declaring that the FDA had improperly approved the drug 23 years ago. Within minutes of that decision, U.S. District Judge Thomas O. Rice in Washington state issued a contrary ruling. Rice decided the current FDA rules need to remain in place, despite the 17 states and the District of Columbia trying to expand the use of mifepristone.

But the justices, for now, left the case in the hands of the 5th U.S. Circuit Court of Appeals, which has scheduled oral arguments in the case for May 17. The case will almost certainly end up at the Supreme Court with a chance for a decision next term as the 5th Circuit rules.

The drug will be widely available in states where the procedure is legal if you are at least 10 weeks into a pregnant woman.

The stay that would apply if we failed to broaden it would not be removed from the market, argued Alito in his dissent. It would simply restore the circumstances that existed (and that the Government defended) from 2000 to 2016 under three Presidential administrations.”

Biden said that he had stood by the FDA’s approval of mifepristone and his administration would defend FDA’s authority to review and approve drugs.

“The stakes could not be higher for women across America. I will continue my fight against attacks on women’s health. The American people have the power to change the Congress, and they should use their vote to restore the rights of the unborn, Biden stated.

The appeals court is unlikely to change its view after hearing the case in person. Its 42-page preliminary order is based, in part, on the Comstock Act, a law that for generations has not been enforced. In order to prevent the mailing of obscene or lewd materials, as well as to prevent the mailing of drugs used for birth control or for the purposes of “unlawful abortion”, the statute was enacted in 1873.

The approval of the pill nationwide was revoked by a Texas judge on April 7. The plaintiffs in the case, antiabortion doctors, argued that the drug is unsafe and the FDA’s authorization was improper because pregnancy is not an illness. However, the drug has a decades-long track record of safety, and a comprehensive review conducted by the National Academies of Sciences confirmed that it has a very low rate of serious complications.

GenBioPro, the manufacturer of a generic form of mifepristone, entered the fray this week with a lawsuit against the FDA. The generic version of Gen BioPro would be temporarily suspended if the approval of Mifepristone were to be revoked. The company alleges that if the FDA complies with Kacsmaryk’s ruling, it would violate the established legal process for withdrawing a previously approved drug from use.

Ameet sarpatwari is an assistant professor of medicine at Harvard Medical school and he says there is a very detailed procedure of removing drugs from the market. Kacsmaryk’s ruling circumvents that established process, Sarpatwari says. The FDA and manufacturers have taken drugs off the market before, either because of low demand or other reasons, but never has a court removed a long approved drug from use.

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