> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Senate Democrats Caution FDA on Mifepristone Review
- URL: https://www.fdaweb.com/senate-democrats-caution-fda-on-mifepristone-review/
- Published: 2025-11-07T12:00:00.000Z
- Updated: 2026-09-14T15:26:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160183

Senate Democrats says they are worried that FDA and HHS may rely on partisan “junk science” during its recently announced review of the existing safety and effectiveness data of the abortion drug mifepristone. In a [11/6 letter ](https://static.notus.org/52/63/4705b649458eb7ae0ac9d33947da/11-06-2025-letter-to-hhs-and-fda.pdf?ref=fdaweb.com)to FDA and HHS, the Democrats expressed concern that the administration might rely on a report from the conservative Ethics and Public Policy Center claiming nearly 11% of women experience serious complications after using mifepristone. The report is not peer-reviewed and has been widely criticized by health experts, they said.

“The FDA should be using gold-standard science and evidence when making decisions about medication access for the American people,” the senators wrote, demanding a response by November 28 outlining the evidence being reviewed, the process for review, and how the FDA will comply with the court’s order.

The letter also reminded FDA and HHS that a Hawaii court recently ruled that certification requirements for providers, mandatory documentation for patients, and pharmacy restrictions are “burdensome” and “unwarranted.” A U.S. District Court in Hawaii [ruled ](https://assets.aclu.org/live/uploads/2017/10/2025.10.30-Purcell-v.-Kennedy-Opinion.pdf?ref=fdaweb.com)that FDA acted unlawfully by imposing certain restrictions on mifepristone. The court found the agency failed to provide a reasoned explanation for its restrictive regulation of the medication. The case centered on an agency-mandated Risk Evaluation and Mitigation Strategy, which subjects the drug to stricter regulations than many other medications. The matter has been remanded to FDA to reconsider the mifepristone REMS.