WASHINGTON, D.C. (LifeSiteNews) — Federal health officials have responded to the pro-life uproar over the U.S. Food & Drug Administration’s (FDA) approval of a new version of the abortion pill, claiming it had no legal choice but to approve generic equivalents of already-approved products.
On Thursday, it was revealed that the FDA approved a new generic version of mifepristone manufactured by Evita Solution and sold with the help of GenBioPro, finding them “bioequivalent and therapeutically equivalent to” Mifeprex. Evita’s stated mission is to “normalize abortion” and make it “accessible to all.”
Many conservative and pro-life voices responded with shock and outrage to the news, including Sen. Josh Hawley (R-MO), Lila Rose, and Kristan Hawkins, with several calling it a betrayal of the Trump administration’s commitment to a thorough review of the safety data on mifepristone.
Health & Human Services (HHS) Secretary Robert F. Kennedy Jr. responded that “federal law requires approval when an application proves the generic is identical to the brand-name drug,” and insisted that the FDA’s review was still ongoing. “The Biden administration removed mifepristone’s in-person dispensing rule without studying the safety risks. We are filling that gap,” he said. “Recent studies already point to serious risks when mifepristone is used without proper medical oversight.”
HHS spokesman Andrew Nixon reiterated that answer to the Washington Post, stressing the FDA “has very limited discretion in deciding whether to approve a generic drug,” adding that the agency is “conducting a study of the reported adverse effects of mifepristone to ensure the FDA’s risk mitigation program for the drug is sufficient to protect women from unstated risks. The FDA does not endorse any drug product and directs prescribers to follow all labeling.”
However, the Post noted that the FDA does have various tools that can be used to delay such approvals, “such as requesting more data from manufacturers. The agency took 10 years to approve the first generic version of mifepristone, made by GenBioPro.” So it is unclear why this new version could not have been delayed until after the review is finished, and with it a policy change on all versions of mifepristone.
The matter is particularly urgent in light of the fact that unregulated, no-oversight distribution of abortion pills across state lines has arguably become the abortion lobby’s most effective tactic for circumventing state pro-life laws, as pills can be mailed, received, and taken in complete privacy, without any sign law enforcement can act on.
As for the political implications, an unidentified pro-life consultant told the Post, “It’s a delicate situation, because I think the intelligent people in the pro-life movement don’t want to go to war with the administration. What they want to do is find a reasonable solution,” because “if you do something that embarrasses Trump and the HSS [sic] secretary and the high-profile people, then you wind up with Trump digging in his heels — and you don’t want that.”