US Supreme Court Judge Samuel Alito intervened Friday to temporarily block decisions of lower courts to impose restrictions on mifepristone, a pill used for medical abortion. The move is essentially a pause on a Texas judge’s ruling last week to strike down the drug’s approval by the Food and Drug Administration. It also vacates the decision of the Fifth Circuit Court of Appeals I try Wednesday afternoon to curb access to drugs.
It means that the use of mifepristone remains legal and can continue to be distributed by mail and taken up to the 10th week of pregnancy, at least until midnight on Wednesday, April 19, when the temporary suspension 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 storm over mifepristone erupted on April 7, when Judge Matthew Kacsmaryk of the Northern District of Texas ruled to revoke its FDA approval, overturning decades of scientific consensus on the drug’s safety. Kacsmaryk’s ruling asserted that the pill was unsafe and that the FDA failed to do its due diligence when it approved it in 2000. It was the first time a court had intervened to remove a long-approved drug from the market, and the ruling most important reproductive rights since the Supreme Court struck down Roe vs. Wade.
On the same day as Kacsmaryk’s ruling, a Washington state judge issued a contradictory ordersaying the FDA should keep 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 weighed its safety and efficacy. It’s also approved in the UK, Sweden, and dozens of other countries. The first pill in a two-step regimen blocks the hormone progesterone, which is necessary for pregnancy. A second drug, misoprostol, is taken 24 to 48 hours after mifepristone to complete the abortion. The combination of two pills can be used up to the first 10 weeks of pregnancy. As of 2020, medical abortion accounted for just over half of all abortions in the US.
On Wednesday night, a federal appeals court partially blocked Kacsmaryk’s order, keeping mifepristone on the market but imposing certain key restrictions on its access. The ruling, which came from the conservative US Court of Appeals for the Fifth Circuit, would prevent dispensing the pill by mail and would shorten the window in which it can be obtained from 10 weeks to seven. These new restrictions would reverse changes the FDA made in recent years to broaden the availability of the pill, particularly during the pandemic, when telehealth became a necessity for some patients.
On Thursday, April 13, US Attorney General Merrick Garland said the Justice Department sought “emergency relief from the Supreme Court to uphold the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care. The department filed its appeal with the Supreme Court on Friday morning.
Legal experts and those in the pharmaceutical industry fear that court intrusion into the FDA’s authority could put access to other risk medicationsespecially those considered politically sensitive, such as hormonal birth control, drugs to prevent HIV infection, or even vaccines.