MedPath

Senate Confirms Makary and Bhattacharya to Lead FDA and NIH Amid Healthcare Reform Push

• The Senate health committee has voted to advance Dr. Marty Makary as FDA Commissioner and Dr. Jay Bhattacharya as NIH Director, with the full Senate expected to confirm both nominees due to Republican majority.

• Both nominees gained prominence as COVID-19 contrarians and have pledged alignment with the Trump administration's "Make America Healthy Again" agenda, focusing on chronic diseases and scrutinizing food additives and advisory panel conflicts.

• The confirmations come during a tumultuous period for federal health agencies, with FDA experiencing layoffs, rehirings, and workforce reduction initiatives that may impact regulatory operations.

The Senate health committee voted on Thursday to endorse Dr. Marty Makary as Food and Drug Administration commissioner and Dr. Jay Bhattacharya as director of the National Institutes of Health, advancing both nominees toward likely confirmation by the full Senate.
The committee voted 14-9 to advance Makary, with Democratic senators Maggie Hassan (N.H.) and John Hickenlooper (Colo.) joining Republicans in support. Bhattacharya's nomination passed by a narrower 12-11 margin along party lines. With Republicans holding a majority in the Senate, both nominees are expected to be confirmed in the upcoming full chamber vote.
"The American people's trust in public health institutions must be restored," said Senate health committee Chairman Bill Cassidy (R-La.) before the vote. "Dr. Bhattacharya and Dr. Makary have demonstrated that they are ready to take on this responsibility."

Agency Turmoil and Workforce Challenges

The nominations come during a period of significant disruption at both agencies. The FDA recently experienced a roller coaster of personnel changes, with hundreds of probationary employees overseeing medical devices, food, and tobacco initially laid off in February, only to be rehired a week later.
However, ongoing workforce reduction initiatives—including a $25,000 buyout offer, mandatory return-to-work orders, and the threat of future layoffs—continue to create uncertainty within the agency. These disruptions raise questions about the FDA's capacity to fulfill its regulatory mission effectively in the coming months.
Similar workforce challenges face the NIH, where layoffs and cuts to university funding through indirect payments have created instability in the research community.

Makary's Vision for the FDA

Dr. Makary, a pancreatic surgeon at Johns Hopkins, faced relatively mild questioning during his confirmation hearing. When pressed about recent FDA controversies, including a canceled vaccine advisory committee meeting and workforce reductions, he distanced himself from these decisions while promising to assess the situations.
While offering limited specifics on day-to-day operational plans, Makary indicated interest in:
  • Leveraging real-world data and artificial intelligence to accelerate product reviews
  • Streamlining approvals for biosimilars, generics, and over-the-counter drugs to reduce costs
  • Implementing stricter scrutiny of food additives
  • Revisiting potential conflicts of interest on public health advisory panels
  • Further studying the abortion drug mifepristone
On vaccines, Makary stated they save lives but stopped short of explicitly recommending them to combat the current measles outbreak, a position that aligns with the administration's more cautious stance on vaccine promotion.

Bhattacharya's Research Priorities

Dr. Bhattacharya, a Stanford health economist, similarly aligned himself with the Trump administration's "Make America Healthy Again" (MAHA) agenda, particularly its focus on chronic diseases. Like Makary, he acknowledged the value of vaccinations while leaving the door open to further federal research addressing vaccine critics' concerns.
When questioned about specific NIH programs, Bhattacharya avoided firm commitments on reinstating certain research initiatives, such as grants for LGBTQ+ research, or reversing caps on indirect payments to universities. This ambiguity has left research institutions uncertain about future funding priorities and availability.

Controversial Backgrounds

Both nominees share similar political trajectories. Initially known for critiquing flaws in the U.S. healthcare system, they gained wider recognition as COVID-19 contrarians. Makary opposed certain vaccine and mask mandates, while Bhattacharya co-authored a controversial memo advocating for herd immunity during the pandemic.
These positions brought them closer to Health and Human Services Secretary Robert F. Kennedy Jr., ultimately leading to their nominations for these key healthcare leadership roles.

Mixed Reactions from the Medical Community

The nominations have elicited divided responses from healthcare professionals. Supporters and colleagues have expressed confidence in both candidates' abilities to perform their duties and resist political pressure that contradicts scientific evidence.
Critics, however, worry that their contrarian tendencies might persist, potentially undermining established scientific consensus on important public health matters.

CDC Leadership Vacancy

In a related development, President Trump withdrew the nomination of Dave Weldon to lead the Centers for Disease Control and Prevention hours before Weldon was scheduled to appear before Cassidy's committee. Senator Cassidy indicated that Weldon lacked sufficient support from senators but declined to elaborate on specific concerns that may have been communicated to the White House.
This withdrawal leaves a significant leadership gap at the CDC as the administration works to implement its healthcare agenda across federal agencies.

Implementation Challenges Ahead

As Makary and Bhattacharya prepare to assume their roles, they face the complex task of implementing the administration's MAHA agenda while navigating workforce challenges, addressing ongoing public health concerns, and maintaining the scientific integrity of their respective institutions.
Their ability to balance political priorities with evidence-based approaches will be closely watched by healthcare professionals, researchers, and the public in the coming months.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

© Copyright 2025. All Rights Reserved by MedPath