FDA Vaccine Chief Resigns, Citing Concerns Over Kennedy's Stance on Vaccines; BIO Statement

The Food and Drug Administration's top vaccine official, Dr. Peter Marks, has resigned under pressure, directly criticizing Health Secretary Robert F. Kennedy Jr.'s approach to vaccine policy in his departure.

 

In his resignation letter to Acting FDA Commissioner Sara Brenner, Marks wrote: "It has become clear that truth and transparency are not desired by the secretary, but rather he wishes subservient confirmation of his misinformation and lies." Marks was reportedly given the option to resign or be fired during a meeting at the Department of Health and Human Services on Friday.

 

In a subsequent interview, Marks reinforced his concerns, stating: "This man doesn't care about the truth. He cares about what is making him followers."

 

John F. Crowley, president and CEO of the Biotechnology Innovation Organization (BIO), praised Marks' tenure in a statement following the announcement: "Under the extraordinary leadership of Dr. Peter Marks, the FDA shepherded in a new era of scientific breakthroughs -- from new vaccines to curative cell and gene therapies that have strengthened and saved the lives of millions of patients and families."

 

Crowley expressed concern about potential ramifications for healthcare innovation, noting: "We are deeply concerned that the loss of experienced leadership at the FDA will erode scientific standards and broadly impact the development of new, transformative therapies to fight diseases for the American people."

 

BIO emphasized its commitment to working with the new Commissioner and administration while stressing the importance of upholding scientific expertise and high standards at health institutions.


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Georgia Life Sciences has joined 43 state and regional life sciences organizations in signing a national Council of State Bioscience Associations (CSBA) letter calling on Congress to take immediate action on three bipartisan policy priorities that are essential to sustaining U.S. leadership in biomedical innovation and supporting patients nationwide. With Congress back in session and several critical programs at risk of expiring, the letter urges congressional leaders to advance the following provisions without delay: 1. Reauthorize the Rare Pediatric Disease Priority Review Voucher (PPRV) Program The PPRV program has been instrumental in incentivizing the development of therapies for children with rare and life-threatening conditions. Its lapse threatens to slow or halt research that families across the country are counting on. 2. Extend the SBIR/STTR Programs The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs provide crucial early-stage capital for emerging biotech and medtech companies—many of them in Georgia. Without reauthorization, hundreds of innovative small businesses face uncertainty, jeopardizing new therapies, diagnostics, and technologies in the pipeline, 3. Advance PBM Transparency Reforms Greater transparency and accountability within pharmacy benefit manager (PBM) practices are needed to ensure that savings reach patients and employers. Reforming PBM operations is essential to strengthening access and affordability across the healthcare system. A Unified Message from the Life Sciences Community The sign-on letter reflects broad, bipartisan alignment across the national life sciences ecosystem: researchers, entrepreneurs, investors, patient advocates, and state associations all share a common message— these programs underpin America’s global competitiveness and are vital to patients who rely on continued scientific progress. Georgia Life Sciences has shared the letter with members of Georgia’s congressional delegation and will continue engaging with policymakers to emphasize the importance of swift action.
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Georgia Life Sciences is proud to stand with patient advocates, providers, and employers across the state in urging Congress to take meaningful action on pharmacy benefit manager (PBM) reform. We recently signed on to a joint letter to Georgia’s Congressional Delegation stressing the urgent need for transparency, fair practices, and policies that ensure savings flow directly to patients.
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Georgia Life Sciences’ CEO, Maria Thacker Goethe shares her perspective on the value of Georgia’s research universities in this month’s issue of Georgia Trend. “Georgia research institutions have felt a very significant impact from the federal rollbacks, specifically in NIH and NSF funding. Thacker Goethe’s message about the impact of research cuts is simple: Disruption shatters the foundational trust researchers have in grant continuity….” To read the full article, click here .
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