Gallego, Senate Dems Demand Answers on Trump Admin’s New “Review” of Mifepristone

"We are seriously alarmed by this administration's obvious attempts to interfere with the science and politicize the drug review process in order to restrict abortion access."

WASHINGTON - Today, Senator Ruben Gallego (D-AZ) joined the entire Senate Democratic caucus in writing to U.S. Department of Health and Human Services (HHS) Secretary Kennedy and U.S. Food and Drug Administration (FDA) Commissioner Makary expressing alarm over the Trump administration's plans to conduct "its own review of the evidence" on the safety and effectiveness of mifepristone.

Mifepristone was approved by the FDA in 2000 and is used in the overwhelming majority of abortions in the United States. Access to medication abortion is more critical than ever in the aftermath of the Supreme Court's disastrous Dobbs decision that overturned the Constitutional right to abortion and allowed dozens of states to enact extreme abortion bans that threaten women's health and lives. According to data from Guttmacher, medication abortion accounted for nearly two-thirds of abortions in the U.S. in 2023, the first year after the Dobbs decision.

"Decades of evidence and hundreds of studies prove the safety and efficacy of mifepristone, which is not only the most common method of abortion in the U.S., but is also frequently prescribed to women to help manage early pregnancy loss or miscarriage. We are alarmed by the Department's obvious attempts to politicize the review, regulation, and approval of mifepristone at the FDA, and we write to request more information," the senators wrote.

The letter lays into a recent junk science "report" put out by the Ethics and Public Policy Center (EPPC), an avowedly anti-abortion think tank, that appears to be the basis for the Trump administration's announced review of mifepristone. The EPPC report parrots anti-abortion disinformation, was not peer-reviewed or published in any medical journal, and has been widely criticized by reputable health organizations since its release.

"By elevating the sham EPPC report as rationale for restricting access to mifepristone, HHS is blatantly undermining well-established science and weaponizing disinformation to fit the Trump administration's clear agenda to cut off abortion access in any way possible," the senators continued. "FDA relying on a partisan, sham report as part of the evidence review for any drug is deeply concerning-and in this case, it's clear that the Trump administration is downright eager to do away with established science if it helps further their extreme anti-abortion agenda."

Mifepristone is already subject to burdensome Risk Evaluation and Mitigation Strategy (REMS) requirements that must be followed for prescribing and dispensing mifepristone-in fact, FDA already restricts mifepristone more heavily than 99.5% of the over 20,000 prescription drugs it regulates. On October 30th, a federal court ruled that the FDA's explanation for its current restrictions on mifepristone is unreasoned, unsupported, and illogical.

"The bottom line is that access to mifepristone allows patients to receive time-sensitive, essential health care, including abortion care and miscarriage management," the senators continued. "If HHS insists on rejecting the science that clearly proves mifepristone is safe and effective, and instead decides to impose additional restrictions on its use, this will force countless women to carry pregnancies to term against their will-regardless of the consequences for their health or lives."

The senators concluded by demanding answers on what exactly prompted the administration to initiate the review, what process will be used to conduct it, whether there is any unreported data on adverse events it is considering, and how FDA will ensure compliance with the court order in Purcell v. Kennedy.

"The American people need to be able to trust that any reviews, regulations, and approvals of medication by HHS and FDA are based on science and evidence-not on partisan attempts to attack abortion access," the senators concluded. "It is critical that scientific experts and evidence are central to any FDA review or REMS initiative. Mifepristone has long been shown to be safe and effective, and there is no new evidence to justify burdensome restrictions that block women from getting the health care they need."

Read the full letter HERE.

11/7/25