United States Supreme Court Justice Samuel Alito on Friday steps in temporarily block lower court decisions imposing restrictions on mifepristone, a pill used for a medical abortion. The measure essentially halts a Texas judge’s ruling last week to revoke the drug’s approval by the Food and Drug Administration. It also overrides the Fifth Circuit Court of Appeals’ try late on Wednesday to limit access to drugs.
That means mifepristone is still legal to use and can continue to be mailed and used until the 10th week of pregnancy—at least until midnight Wednesday, April 19 , when the holding period expires.
The Justice Department is appealing the 5th Circuit decision, and the Supreme Court has given all parties until noon Tuesday, April 18, to submit their responses.
The legal storm over mifepristone erupted on April 7, when Judge Matthew Kacsmaryk of the Northern District of Texas ruled to revoke FDA approval, overcoming decades of scientific consensus on the drug’s safety. . Kacsmaryk’s ruling stated that the pill was unsafe and that the FDA did not do due diligence when approving it in 2000. This is the first time a court has intervened to withdraw a long-approved drug. from the market and is the most important reproductive rights ruling since the Supreme Court overturned Roe sues Wade.
On the same day as Kacsmaryk, a judge in Washington state issue a contradictory ordersays 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 weigh its safety and effectiveness. It is also approved in the United Kingdom, Sweden and dozens of other countries. As the first pill in a two-step regimen, it blocks the hormone progesterone needed for pregnancy. The second drug, misoprostol, is given 24 to 48 hours after mifepristone to complete the abortion. The two-pill combination can be used until the first 10 weeks of pregnancy. As of 2020, medical abortion accounts for just over half of all abortions in the US.
Late Wednesday, a federal appeals court Kacsmaryk’s command is partially blocked, keeps mifepristone on the market but imposes some key restrictions on its access. The ruling, which came from the conservative U.S. Fifth Circuit Court of Appeals, will block mailing of the drug and shorten the time it takes to receive it, from 10 weeks to seven weeks. These new restrictions will roll back changes the FDA has made in recent years to expand drug availability, especially during a pandemic, when telehealth becomes essential. for some patients.
On Thursday, April 13, U.S. Attorney General Merrick Garland said the Justice Department had sought “urgent relief from the Supreme Court to defend FDA’s scientific judgment and protect access to safe and effective reproductive care for Americans.” The department filed an appeal with the Supreme Court on Friday morning.
Legal experts and pharmaceutical industry insiders are concerned that court intervention in FDA’s jurisdiction could lead to access to other drugs at riskespecially those that are considered politically sensitive, such as hormonal birth control, drugs to prevent HIV infection or even vaccines.
