FDA approves second generic mifepristone amid GOP pressure
Evita Solutions approved despite Kennedy's promised safety review
The FDA approved a second generic mifepristone product tied to Evita Solutions in early Oct. 2025, a routine generic approval under FDA standards for therapeutic equivalence.
Key People
5DM
Dr. Marty Makary
FDA Commissioner
As FDA Commissioner, Dr. Makary co-signed the Sept. 19, 2025 letter saying the FDA would review real-world safety data on mifepristone and leads the agency that issued the Oct. 2025 generic approval.
Robert F. Kennedy Jr.
HHS Secretary
As HHS Secretary, Kennedy co-signed the Sept. 19, 2025 letter pledging an agency review of mifepristone safety after requests from Republican state attorneys general.
G
GenBioPro
First U.S. generic mifepristone manufacturer
received FDA approval for a generic mifepristone on Apr. 11, 2019 and has been a major supplier of mifepristone in U.S. care.
ES
Evita Solutions LLC
Newly approved generic manufacturer
Evita announced FDA approval in early Oct. 2025 and posted the approval on its website prior to an FDA press release. The company stated plans to make product available in subsequent months.
SF
Students for Life Action and Senator Josh Hawley
Critics
Both publicly denounced the FDA's approval in Oct. 2025, framing it as a policy failure and calling for further review or restrictions.
Claims & Perspectives
True
True
The FDA approved Evita Solutions' generic mifepristone on Oct. 2, 2025.
Multiple national outlets reported the FDA action dated Oct. 2, 2025. [1][2] Drugs.com lists Evita as a recently approved generic entry consistent with those reports. [3] The approval was reported as a routine generic equivalence decision by the FDA. [1]
True
HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary sent a joint letter on Sept. 19, 2025 saying the agencies would review 'real-world outcomes' for mifepristone.
Kennedy and Makary co-signed a letter dated Sept. 19, 2025 committing the agencies to review evidence and 'real-world outcomes.' [1][3] State attorneys general publicly responded the same week. [2]
False
False
Evita Solutions filed its ANDA in 2021.
Major coverage of the approval does not state a 2021 ANDA filing for Evita. [1][2] The FDA notes generic reviews typically aim for a 10-month review, but news reporting does not confirm a 2021 submission date for Evita. [3] The 2021 filing claim lacks documentary support in the reviewed sources.
False
The FDA permanently 'permitted' online prescribing and mail delivery of mifepristone in 2021.
The FDA issued temporary pandemic-era flexibilities around 2020–2021, but permanent REMS modifications expanding dispensing were implemented in 2023. [1][2] Reporting since 2023 ties broader permanent changes to the 2023 REMS update, not a 2021 permanent rule. [3]
Disputed
Disputed
The mifepristone-plus-misoprostol regimen makes up about two-thirds of U.S. abortions.
Multiple outlets and industry statements describe medication abortion as the most common early abortion method and cite roughly two-thirds market share. [1][2] Public health data sources use different denominators and dates, so precise share estimates vary by report. [3]
Disputed
A second generic approval will not change access in states with near-total abortion bans.
Federal approval does not automatically nullify state bans because courts and state laws shape local access. [1][2] Courts have split on preemption and enforcement, so the practical effect of a second generic on state access remains contested. [3]
Disputed
The FDA's REMS still requires prescriber certification, but 2023 changes expanded pharmacy dispensing.
Manufacturer and reporting show the REMS still governs distribution and certification responsibilities. [1][2] The 2023 REMS changes expanded dispensing and made prescriber and pharmacy procedures more flexible. [3] Debates continue over how those rules operate amid litigation.
What you can do
Submit comment to FDA on REMS
civic action
Use the FDA's public docket to file comment on any proposed REMS changes and cite the agency's 25-plus years of safety monitoring.
Request congressional oversight
civic action
Contact members of the Senate HELP Committee to request hearings on agency review procedures when approval decisions overlap with political pressure.
Support legal defense funds
practicing
If you wish to back litigation defending access to medication abortion, consider established legal groups that litigate reproductive rights.