FDA Abortion Pill Safety Review Expected to Conclude by September, Congress Members Were Told

Since the Wall Street Journal reported on June 4 that the FDA's mifepristone safety study had officially launched after moving through the data collection phase, the timeline for a final ruling has come into sharper focus. A lawmaker who asked to remain anonymous told the Daily Signal that a few members of Congress were told to expect the review to be complete by September.

The Daily Signal's exclusive is the primary source for the September target. The Department of Health and Human Services did not respond to the Daily Signal's request for comment, so the timeline remains an informal congressional read-out, not an official FDA announcement.

What the Review Could Actually Do

The FDA's study is a retrospective analysis of hundreds of thousands of mifepristone cases, according to a senior FDA official who spoke to CBS News. The interim results of the study could be released in July, the official said, though the final timeline depends on the design of a secondary analysis that follows those interim findings.

If the review concludes the drug poses unacceptable risks under current conditions, the FDA could revise mifepristone's Risk Evaluation and Mitigation Strategy, known as REMS, to reinstate the in-person dispensing requirement. In April 2021, the Biden administration's FDA stopped requiring that abortion pills be dispensed to women in person, allowing them to be prescribed at telehealth appointments and shipped through the mail. The Biden FDA made the change permanent in 2023. Those changes allowed mifepristone to be prescribed via telehealth and mailed directly to patients.

The Trump administration's position, stated by White House spokeswoman Allison Schuster to the Daily Signal, is that the review has been underway for months and is not a new launch. "The Trump Administration is pursuing a rigorous review of mifepristone in response to widespread safety concerns, adhering to the highest scientific standards," Schuster said. The FDA's own spokesperson disputed framing the study as newly started, calling such reports "either false or based on a fundamental misunderstanding of how complex scientific safety studies work."

The Safety Data in Dispute

The core number driving the pro-life push is from the Ethics and Public Policy Center, which released a study in April 2025 finding that roughly 11% of women who used mifepristone experienced serious adverse events — sepsis, infection, or hemorrhaging — within 45 days. That figure is dramatically higher than the less than 0.5% rate reported in the clinical trials that appear on the FDA's approved drug label.

A McLaughlin & Associates poll cited by the Daily Signal found that seven in ten American voters say they don't believe it is safe for abortion drugs to be sent through the mail.

The Other Side of This Argument

Proponents of current access make a straightforward case: mifepristone has been FDA-approved since 2000, used by more than 7.5 million patients according to Planned Parenthood CEO Alexis McGill Johnson, and its safety record in clinical trials is well-established. Johnson called the FDA review "a politically motivated farce" in a statement reported by CBS News. The concern is that the review's conclusion is predetermined. Whether the EPPC's 11% adverse-event figure represents a true causal harm rate or reflects confounding factors in retrospective claims data is a scientific dispute the FDA's own analysis is supposed to resolve.

Congressional Maneuvering and the Courts

Pro-life members on the House Appropriations Committee considered inserting a provision into an agriculture and FDA funding bill that would have nullified the Biden mail-order rule outright. They held off, according to the Daily Signal, specifically to let the FDA review run its course first. That pause could evaporate if the September deadline slips.

The legal track is running parallel. Louisiana filed suit challenging the mail-order rule. On May 4, the 5th U.S. Circuit Court of Appeals temporarily reinstated the in-person dispensing requirement. The Supreme Court stepped in the following week and set that order aside, allowing mail-order access to continue while the Louisiana case proceeds. Rosalie Markezich, who alleges her boyfriend ordered mifepristone online from a California provider and coerced her into taking it, is a co-plaintiff in that suit.

What Changed at the FDA

Former FDA Commissioner Marty Makary resigned last month amid criticism from Republican lawmakers and anti-abortion groups who believed he was delaying action on mifepristone. His replacement, acting commissioner Kyle Diamantas, contacted pro-life leaders shortly after taking the role and signaled the review would move forward. CBS News noted that HHS Secretary Robert F. Kennedy Jr. had already written to Republican state attorneys general last September stating that an FDA review was underway.

No investigation, charge, or formal enforcement action against any prescriber or pharmacy operating under the current mail-order rules has been announced. The review remains a regulatory process, not a legal one, and no charges have been filed against anyone in connection with the current dispensing regime.

The open question is whether the interim results, which could be released in July, will be made public or shared only internally — and whether the White House will act on them before the full review concludes in September.