Drugs

2nd Generic Mifepristone Approved, Prompting Backlash

FDA is facing mixed reactions after approving the second generic copy of the abortifacient drug mifepristone 10/2. The manufacturer, Evita Solutions, becomes the second company authorized to market a generic version of the drug, joining GenBioPro, whose generic version was approved in 2019.

The approval comes at a time of heightened scrutiny over mifepristone’s safety profile. Last month, HHS secretary Robert F. Kennedy, Jr., and FDA commissioner Martin Makary said the agency is leading a review of the drug’s safety based in part on a study by the Ethics and Public Policy Center (see earlier story). They said FDA is “conducting its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of the drug. Given the 2016 FDA decision to eliminate the REMS (Risk Evaluation and Management Strategy) requirement for certified prescribers to report non-fatal serious adverse events to the mifepristone sponsors, this review will contribute to the understanding of the drug’s safety profile.”

In a response, the advocacy group Democracy Forward said the drug’s safety and efficacy have been well established over its 25 years of approval and use. “This attempt to undermine medication abortion comes at the same time that the anti-science community, emboldened by the president, is pushing junk science to spread misinformation about autism and the use of acetaminophen,” it said. The group challenged the study, describing it as “an anti-abortion funded effort with significant flaws in methodology and findings.” It says the federal government should “heed medically accurate, peer-reviewed, and evidence-based approaches to medication regulation and utilize the expertise that has been developed over decades by the non-partisan career civil service.”

On Capitol Hill, several Republican senators immediately criticized the approval, accusing FDA and HHS of overreach and undermining pro-life principles. For example, Senator Josh Hawley called it a betrayal, saying FDA “flagrantly disregarded” demands for additional safety review. Democratic lawmakers and pro-choice advocates framed the decision as a win for patients' health and reproductive autonomy:

Meanwhile, the White House 10/3 defended FDA’s approval, stopping short of offering an endorsement of the drug. White House press secretary Karoline Leavitt said the agency was legally required to approve the drug. “It’s not an endorsement of this drug by any means. They are just simply following the law,” Leavitt told reporters. “By law, the secretary of the Department of Health and Human Services must approve a generic drug application if the application demonstrates the drug is the ‘same’ as the brand-name drug.”

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome