Abortion Pill Order Sets Clock on Long-Awaited HHS Safety Study

A Trump-appointed judge set a ticking clock for the US Food and Drug Administration to deliver on a long-awaited abortion pill safety review, triggering frustration from abortion opponents and concern from reproductive rights supporters.

The Trump administration is facing accusations from anti-abortion advocates and others that it’s slow-walking a review of mifepristone, a prevalent form of abortion medication, for fear of political blowback ahead of the midterms.

Federal Judge David C. Joseph on April 7 added to the pressure on the administration, pausing a lawsuit from Louisiana seeking to block mailing of mifepristone until the FDA provides an update on its study. Joseph, of the US District Court for the Western District of Louisiana, told the administration he expected an update on the study within six months, and suggested he wouldn’t tolerate delay.

US Department of Health and Human Services spokesperson Andrew Nixon said in response to the ruling that the FDA “is taking care to do this study properly and in the right way.” In academia, such studies “often take approximately a year or more to conduct. The agency plan is to have this study done sooner than that timeframe,” Nixon said.

Louisiana is appealing the decision to the US Court of Appeals for the Fifth Circuit, which previously ruled in favor of restricting medication abortion. Liz Murrill, Louisiana’s attorney general, said the state will ask the court to do “the only thing left to do"—strip the FDA’s decision to allow mifepristone to be mailed, pending the litigation’s outcome.

As Louisiana’s lawsuit remains on hold, groups both in favor of and opposed to mifepristone access are on edge about the future of mifepristone access.

Erik Baptist, senior counsel at Alliance Defending Freedom, which represents a fellow plaintiff to Louisiana in the case, said his group was “extremely disappointed” in the decision, and that the stay “allows the FDA to delay accountability indefinitely.”

“Louisiana is temporarily hamstrung from enforcing its pro‑life laws while the FDA embarks on a study that has not even started and could easily surpass a year or more,” Baptist said.

But Emily Steinert McDowell, associate director of federal policy for Reproductive Freedom for All, warned Joseph’s ruling carries some concern for abortion advocates.

The decision, she said, “repeatedly incorporates anti-abortion disinformation about the safety and efficacy record of mifepristone without interrogating those baseless claims.”

Now, with Louisiana’s appeal, the case goes to “a conservative circuit court with even more Trump-appointed judges,” she said. “We have to be ready.”

Ready for Review

Reproductive rights groups say mifepristone has widely been proved to be safe, and the limited research stating otherwise has been discredited. A Guttmacher study found that in 2023, medication abortion accounted for over 60% of abortions in the US.

Nevertheless, in April 2025, conservative group Ethics & Public Policy Center put out a study claiming one in 10 abortion pill patients experience an adverse event. Following that report, the HHS agreed to conduct its own review.

The delay in that report triggered lawmakers to call for the government to move forward more quickly with its research.

Generic mifepristone manufacturer GenBioPro, a company involved in the Louisiana case, is confident the review will demonstrate the pill’s safety.

“We fully expect the FDA’s review of mifepristone to reaffirm the more than a quarter century of scientific research, FDA and regulatory review, and real-world use, showing mifepristone to be safe and effective, including when dispensed without an in-person visit,” Evan Masingill, GenBioPro CEO, said in a statement.

However, former White House Gender Policy Council deputy director Katie Keith said medication abortion is still under threat both by the Trump administration and courts.

“All eyes will now be on the FDA’s so-called ‘review’ of mifepristone and litigation in states like Missouri and Texas—which could lead to swift and severe nationwide limits on medication abortion,” Keith, who is also founding director of the Center for Health Policy and the Law at Georgetown Law, said in a statement.

In the Courts

Access to mifepristone is an issue that has gone all the way to the US Supreme Court.

In their 2024 decision in FDA v. Alliance for Hippocratic Medicine, the justices upheld abortion pill access, though they did so on standing, leaving the door open for future challenges.

“Regardless of what the FDA decides, the case will end up back before the Supreme Court,” said Greer Donley, a University of Pittsburgh law professor specializing in abortion.

The “review could take years, and even once it concludes, the FDA could reaffirm its prior decision,” Donley said. “On the other hand, if the FDA goes back on its prior decision, blue states and civil rights organizations will immediately sue the agency.”

The district court decision wasn’t entirely a loss for Louisiana.

Joseph’s opinion said Louisiana “has established injury that is traceable to FDA’s actions and redressable, at least in part, by the relief requested,” and thus has standing.

He also said President Donald Trump’s HHS “essentially acknowledged” procedural problems in mifepristone decision-making, and that the intent to review the drug was spurred in part by “recent safety concerns,” meaning Louisiana was likely to succeed in its challenge.

“Even the court acknowledged the destruction caused by the FDA policy on chemical abortion,” Tony Perkins, Family Research Council president and a former Louisiana legislator, said in a statement.