FDA approved generic abortion pill before government shutdown

Key takeaways:

• The FDA approved a second generic form of mifepristone.
• HHS is reportedly reviewing mifepristone after state attorneys general raised concerns about its safety and efficacy, but experts support its use.

The FDA has approved a generic form of the abortion pill mifepristone on Sept. 30, just before the government shutdown.

The new generic formulation is manufactured by Evita Solutions. It is the second generic for mifepristone. The first generic — produced by GenBioPro — was approved by the FDA in 2019.

Mifepristone is used with Cytotec (misoprostol, Pfizer) to induce abortions up to 10 weeks after the first day of the last menstrual period, according to Evita Solutions.

Medication abortion accounted for 63% of all abortions in the U.S. in 2023, an increase from 53% in 2020, according to the Guttmacher Institute.

The FDA issued a letter to Evita Solutions stating that the company’s mifepristone tablets are the “bioequivalent and therapeutically equivalent” to the brand-name Mifeprex (Danco Laboratories) tablets. The FDA did not announce the approval in a press release, as it often does for major approvals.

According to Evita Solutions, the mifepristone tablets are available only under the FDA-approved Mifepristone Risk Evaluation and Mitigation Strategy Program.

Several news outlets have reported in recent weeks that HHS and the FDA plan on reviewing the safety of mifepristone after 22 Republican state attorneys general sent a letter to HHS Secretary Robert F. Kennedy, Jr. and FDA Commissioner Martin A. Makary, MD, MPH, outlining their concerns with the drug. In the letter, the state attorneys general claimed the drug is not as safe and effective as stated on the drug’s label.

According to reporting from The New York Times, Kennedy Jr. and Makary said the concerns “merit close examination,” and their review of the evidence will include “real-world outcomes.”

But major medical organizations like ACOG and Planned Parenthood have maintained that the mifepristone is essential to patient care.

“Mifepristone has been conclusively studied and proven to be both safe and effective,” ACOG President Steven J. Fleischman, MD, MBA, FACOG, told Healio. “We hope that the approval of the generic will also make it more accessible and affordable.”

For more information:

Steven J. Fleischman, MD, MBA, FACOG, can be reached through Jamila Vernon at jvernon@acog.org.