United States Supreme Court Judge Samuel Alito intervened on Friday to temporarily block lower court decisions to impose restrictions on mifepristone, a pill used for medical abortion. The measure is essentially a break from a Texas judge’s decision last week to overturn the drug’s Food and Drug Administration approval. It also reverses the attempt by the Fifth Circuit Court of Appeals Wednesday night to restrict access to the drug.
This means that the use of mifepristone remains legal and can continue to be distributed by mail and taken until 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 submit their responses.
The legal firestorm over mifepristone erupted on April 7, when Judge Matthew Kacsmaryk of the Northern District of Texas ruled to revoke its FDA approval, reversing decades of scientific consensus on the drug’s safety. Kacsmaryk’s ruling asserted that the pill was unsafe and that the FDA failed to exercise due diligence when approving it in 2000. It was the first time a court had intervened to remove an approved drug of the market, and the most important decision on reproductive rights since the Supreme Court overturned Roe vs. Wade.
On the same day as Kacsmaryk’s ruling, a Washington state judge issued a contradictory order, saying the FDA must 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 assessed its safety and effectiveness. It is also approved in the UK, Sweden and dozens of other countries. The first pill in a two-step diet, it 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. In 2020, medical abortion accounted for just over half of all abortions in the United States.
Late Wednesday, a federal appeals court partially blocked Kacsmaryk’s order, keeping mifepristone on the market but imposing some key restrictions on its access. The ruling, by the conservative Fifth Circuit US Court of Appeals, would prevent the pill from being distributed by mail and shorten the window in which it can be obtained, from 10 weeks to seven. These new restrictions would reverse changes made by the FDA in recent years to expand the availability of the pill, especially during the pandemic when telehealth became a necessity for some patients.
On Thursday, April 13, U.S. Attorney General Merrick Garland said the Justice Department had requested “emergency assistance from the Supreme Court to uphold the FDA’s scientific judgment and protect the access of Americans 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 interference with FDA authority could jeopardize access to other drugs, especially those considered politically sensitive, such as hormonal contraceptives. , drugs to prevent HIV infection or even vaccines.
