FDA says its safety review of abortion pill will continue into next year

WASHINGTON (AP) — The Food and Drug Administration says its ongoing safety review of the nation’s main abortion pill will continue into next year, a timeline that was quickly condemned by abortion opponents hoping to see the drug’s use curtailed.

The FDA gave a court-ordered update on its progress in a legal filing late Wednesday, providing the first substantive information about the controversial reevaluation ordered by Health Secretary Robert F. Kennedy Jr.

Mifepristone was first approved by the FDA in 2000. The agency has repeatedly reaffirmed the pill’s safety and effectiveness over the years, in addition to easing a number of restrictions on the drug, including dropping a requirement that it be dispensed in person.

But since President Donald Trump returned to the White House, anti-abortion groups and their allies in Congress have pushed the administration to revisit the pill, in the hopes of restricting its use.

The FDA said in its filing that it expects to complete a safety study of the pill by mid-December this year. A report on the findings is expected “no later than March 2027,” after which the agency will decide whether to impose new restrictions or other changes on the drug’s use.

Gavin Oxley of Americans United for Life, an anti-abortion group, criticized the move as a lack of “true leadership” by Trump administration officials.

“The administration continues to find itself on the wrong side of women’s health, clearly uninterested in mitigating the ongoing harms caused by the abortion pill,” Oxley said.

The two-drug regimen of mifepristone, combined with a second drug misoprostol, is the most common form of abortion in the U.S.

The FDA was directed to provide the latest update by a federal judge in a case brought by the state of Louisiana alleging that mail-delivery of mifepristone undermines the state’s abortion ban. It’s one of several state lawsuits related to mifepristone winding their way through the courts.

Last month a three-judge panel for the 5th U.S. Circuit Court of Appeals questioned the merits of Louisiana’s case, including whether the state had the legal standing to challenge FDA’s oversight of mifepristone.

Any ruling from the 5th Circuit on the Louisiana case would not immediately change the landscape because the Supreme Court has blocked changes to the drug until it sees the case again.

The FDA said Wednesday it is using a “statistical data mining method” to discover “unknown safety concerns,” that may exist with the drug. The data comes from an electronic database that collects reports of medical injuries and drug side effects from major health networks and insurers.

In addition to the safety study, the agency said it is considering a number of petitions proposing changes to how mifepristone is prescribed and distributed.

Abortion opponents have focused most of their efforts on a 2021 decision allowing doctors to prescribe the drug online and send it through the mail during COVID-19. That decision, made permanent under President Joe Biden in 2023, had the effect of undermining a number of state abortion bans, since women can receive the drug through the mail.

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