The FDA has recently approved a generic version of mifepristone, a medication commonly used in abortions. This marks the second generic version available, following GenBioPro’s approval in 2019. Mifepristone is usually taken with another pill called misoprostol, and together they account for nearly two-thirds of abortions in the U.S.
The approval happened on a rather quiet Tuesday, just before the government shutdown began. In its letter to Evita Solutions, the FDA noted that this new version is “therapeutically equivalent” to Mifeprex, the original brand name that has been around since 2000.
Evita Solutions is on a mission to make abortion care more accessible. They claim that their generic version will offer an affordable option for those seeking medication abortion, expected to be on shelves by January 2026.
Two weeks before this approval, Health and Human Services Secretary Robert F. Kennedy Jr. indicated that the FDA would review mifepristone’s safety, spurring significant reactions. Critics, like Marjorie Dannenfelser from SBA Pro-Life America, expressed outrage, arguing that the FDA’s decision undermines assurances made to the public regarding safety.
Interestingly, a recent survey found that medication abortion methods, including mifepristone, are preferred by over 70% of individuals seeking abortions. This poses a strong case for their acceptance in the medical community, despite ongoing controversies.
Brittany Fonteno, CEO of the National Abortion Federation, reiterated that medication abortion is both safe and effective. Research has consistently shown that serious complications from these medications are rare, a fact supported by peer-reviewed studies.
However, there are voices calling for tighter regulations. Recently, 22 Republican attorneys general urged the FDA to reconsider the approval of mifepristone, citing concerns from a non-peer-reviewed report claiming higher rates of adverse effects than previously reported. It’s important to approach such findings with caution, as many experts in reproductive health have dismissed them as unreliable.
As discussions around mifepristone continue, it’s clear that the landscape of abortion care is evolving, balancing public health needs with ongoing political debates. For more detailed information on medication abortion statistics, you can check the Guttmacher Institute’s findings here.
