WASHINGTON — A Texas judge could decide as soon as next month whether to force the U.S. Food and Drug Administration to pull its two-decade-old approval of the abortion pill, which accounts for more than half of pregnancy terminations in the United States.
A nationwide injunction in the case, as requested by anti-abortion groups, would deny abortion medication even in states where abortion is legal and affect millions of individuals’ reproductive rights decisions. The legal fight is viewed as likely to eventually make its way to the Supreme Court, which in 2022 overturned the landmark Roe v. Wade decision that legalized abortion rights.
The FDA is urging the federal judge — an appointee of former President Donald Trump — not to issue a preliminary ruling in the case that centers on whether the agency exceeded its authority to approve mifepristone in 2000, whether it erred in making changes to when and how the medication can be used in 2016 and if sending the medication through the mail is legal.
The federal government, in a court filing on Jan. 13, said the anti-abortion groups’ lawsuit to force the FDA to pull the pharmaceutical from the market “is extraordinary and unprecedented.”
“Plaintiffs have pointed to no case, and the government has been unable to locate any example, where a court has second-guessed FDA’s safety and efficacy determination and ordered a widely available FDA-approved drug to be removed from the market — much less an example that includes a two-decade delay,” wrote attorneys for the U.S. Justice Department.
The 52-page opposition to a preliminary ruling says such a decision “would cause significant harm, depriving patients of a safe and effective drug that has been on the market for more than two decades.” Read more