FDA approves second generic mifepristone amid GOP pressure

Public Comment Template: FDA Dockets - REMS for Mifepristone

Subject: Comment on REMS Requirements for Mifepristone Following Evita Approval

Docket Number: [Check FDA docket for current mifepristone/REMS docket] Submit to: dockets@fda.hhs.gov

Comment:

I am writing to comment on the Risk Evaluation and Mitigation Strategy (REMS) requirements for mifepristone following the FDA's Oct. 2, 2025 approval of Evita Solutions LLC's generic mifepristone.

Background: On Oct. 2, 2025, the FDA approved Evita Solutions LLC's generic mifepristone, a second generic alternative to Danco Laboratories' branded Mifeprex, for use through about 10 weeks of pregnancy. This approval followed a Sep. 19, 2025 letter from HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary saying the agencies would review real-world safety data.

Key points:

• The FDA has monitored mifepristone safety for 25-plus years with extensive real-world data
• Medical groups have defended decades of safety data supporting mifepristone use
• The approval of a second generic increases access and competition
• Any REMS changes should be based on scientific evidence, not political pressure

Specific concerns:

1. REMS requirements should not be used to restrict access beyond what is medically necessary
2. Any changes to REMS should be based on safety data, not political considerations
3. The FDA should maintain its scientific independence in evaluating medication safety

Request: I request that the FDA maintain evidence-based REMS requirements for mifepristone and resist any pressure to impose restrictions not supported by 25-plus years of safety monitoring data.

Contact information: [Your name, address, email]

Submission: Submit to: dockets@fda.hhs.gov Phone: 855-543-3784 Or submit online through FDA docket portal

Phone Call Script: Senate HELP Committee - FDA Approval Process Oversight

Opening: Hi, I'm calling as a constituent to request that the Senate Health, Education, Labor and Pensions Committee conduct oversight hearings on the FDA's approval process, particularly regarding political pressure on agency decisions.

Key points to mention:

• On Oct. 2, 2025, the FDA approved Evita Solutions LLC's generic mifepristone
• This approval followed a Sep. 19, 2025 letter from HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary saying the agencies would review real-world safety data
• The decision drew swift criticism from anti-abortion groups and Republican lawmakers
• Medical groups defended decades of safety data
• There are concerns about political pressure influencing FDA approval decisions

Impact explanation: When political pressure influences FDA approval decisions, it undermines the agency's scientific integrity and public trust. The FDA should make decisions based on safety and efficacy data, not political considerations.

Questions to ask:

1. Will the Senate HELP Committee hold oversight hearings on the FDA's approval process for mifepristone?
2. How will the Committee investigate whether political pressure influenced the FDA's decision-making?
3. What safeguards exist to protect FDA's scientific independence from political interference?
4. Will the Committee examine the role of HHS Secretary Kennedy and FDA Commissioner Makary in the approval process?

Specific request: I'm asking the Senate HELP Committee to conduct oversight hearings on the FDA's approval process, investigate any political pressure on agency decisions, and ensure the FDA maintains its scientific independence.

Contact: Senate HELP Committee: 202-224-5375 Website: help.senate.gov

Thank you for your time.