The Food and Drug Administration (FDA) recently granted approval to a new generic form of mifepristone, an abortion medication, a move that has drawn immediate backlash from conservative figures expressing concerns over safety and state-level abortion legislation. The approval was communicated through a letter to Evita Solutions LLC, a telehealth abortion provider that emphasizes its commitment to delivering "safe, affordable, high-quality, effective, and compassionate abortion care." The company's application, submitted in 2021, was approved after federal regulators concluded that it met the necessary U.S. statutory standards.
This decision arrives amidst an FDA review of the drug’s risks based on real-world data. The FDA's process for generic drug approval involves limited discretion, focusing on whether a drug meets the established criteria without requiring new evidence of safety or effectiveness. Andrew Nixon, Communications Director for the Health and Human Services (HHS), stated that an ongoing study is examining reported adverse effects to ensure the FDA's risk mitigation strategies are sufficient to protect patients.
The approval has been met with vocal opposition. Susan B. Anthony Pro-Life America President Marjorie Dannenfelser branded the decision as "reckless" and "unconscionable," citing concerns that chemical abortion drugs pose risks to women and girls, potentially enable abusers, and contravene pro-life statutes in various states. Missouri Senator Josh Hawley criticized the FDA for greenlighting the drug while safety evaluations are still underway, declaring a loss of confidence in the FDA leadership.
Safety concerns are backed by research, such as an Ethics and Public Policy Center analysis of insurance claims between 2017 and 2023, which found that nearly 11 percent of women taking mifepristone faced serious complications within 45 days. Critics argue that bypassing in-person screenings and allowing telehealth distribution could increase risks, especially with ectopic pregnancies or incorrect gestational dating.
The surge in chemical abortions is significant, with the Guttmacher Institute reporting that the use of mifepristone and misoprostol in abortions rose from 39 percent in 2017 to 63 percent in 2023, following the expansion of telehealth services and clinic closures post-Roe v. Wade.
Amidst this controversy, HHS Secretary Robert F. Kennedy Jr. has confirmed a separate review of mifepristone's safety and efficacy. During a Senate hearing, Kennedy accused the Biden administration of manipulating data to obscure safety concerns linked to the drug, intensifying conservative skepticism over federal regulatory integrity.
For opponents of the FDA's recent decision, this development underscores the ongoing contention surrounding chemical abortion safety, regulatory governance, and the expanding role of telehealth in facilitating abortion access. Conservative leaders have vowed to keep a close watch on the distribution of the new generic and to push for state-level measures to mitigate potential risks.
