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US Supreme Court Justice Samuel Alito on Friday moved to temporarily block lower courts’ decisions on the abortion pill mifepristone. The move comes on the heels of a Texas judge’s decision last week to deny the drug’s Food and Drug Administration approval. Also, the Fifth Circuit Court of Appeals will overturn an attempt to limit the use of the drug late Wednesday.
This means mifepristone will remain legal to use, and will continue to be distributed by post and taken until the 10th week of pregnancy – at least until midnight on Wednesday 19 April when the temporary hold expires.
The Justice Department is appealing the Fifth Circuit’s decision, and the Supreme Court has given all parties until noon on Tuesday, April 18, to file their responses.
The legal firestorm over mifepristone ignited on April 7, when Judge Matthew Kaczmaric of the Northern District of Texas decided to overturn the FDA’s approval, overturning decades of scientific consensus on the drug’s safety. Kaczmaric’s ruling said the pill was unsafe and the FDA did not exercise due diligence when it was approved in 2000. It is the first and most important decision a court has made to take a long-approved drug off the market. Since the Supreme Court overturned reproductive rights Roe v. Wade.
On the day of Kaczmaric’s ruling, a judge in Washington state issued a controversial order saying the FDA must make mifepristone available in 17 states and the District of Columbia.
Mifepristone has been available in France since 1988, and was approved by the FDA in 2000 after the agency carefully evaluated its safety and efficacy. It is also approved in the United Kingdom, Sweden and dozens of other countries. The first pill in two steps blocks the hormone progesterone, which is important for pregnancy. A second drug, misoprostol, is taken 24 to 48 hours after mifepristone to induce an abortion. The two-pill combination can be used up to the first 10 weeks of pregnancy. In the year By 2020, medication abortions will account for more than half of all abortions in the US.
Late Wednesday, a federal appeals court partially blocked Kacsmaryk’s order, which kept mifepristone on the market but imposed some key restrictions on its introduction. The ruling from the conservative U.S. Fifth Circuit Court of Appeals prevents the pill from being distributed by mail and shortens the window in which it can be found from 10 weeks to seven. These new restrictions roll back changes the FDA has made in recent years to expand access to the drug, especially during the pandemic, when telehealth became necessary for some patients.
On Thursday, April 13, US Attorney General Merrick Garland said the Justice Department “has sought emergency relief from the Supreme Court to prevent FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care.” The department filed an appeal with the Supreme Court on Friday morning.
Legal experts and courts in the pharmaceutical industry worry that interference in the FDA’s authority could jeopardize access to other drugs, particularly political issues such as hormonal birth control, anti-HIV drugs or vaccines.
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