Two Days, Two Hearings: NIH and FDA Nominees Go Before the HELP Committee
Dr. Jayanta (Jay) Bhattacharya, nominated to be Director of the National Institutes of Health (NIH), and Dr. Martin Makary, nominated to be the Commissioner of the U.S. Food and Drug Administration (FDA), appeared before the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) this week for their confirmation hearings. Dr. Bhattacharya's hearing was held on March 5, 2025, and Dr. Makary's hearing was held on March 6, 2025.
Common themes from both hearings broke down among party lines. Republican members focused on the nominees' respective commitments to increase transparency in federal health agencies and advance President Donald Trump's Make America Healthy Again agenda. Democratic members highlighted concerns about recent actions by the Trump Administration to reduce the size of federal healthcare agencies and impacts on the nation's research enterprise.
The HELP Committee will vote on March 13, 2025, to advance both nominations to the Senate floor for confirmation. Both nominees are expected to be confirmed.
NIH
In his opening statement, Dr. Bhattacharya outlined his five goals if confirmed to lead NIH:
- focus NIH research on chronic diseases
- ensure science is "replicable, reproducible and generalizable"
- foster a culture of free speech in science
- prioritize NIH funding for innovative, cutting-edge biomedical research
- limit "risky" research in a nod to controversies over the origin of COVID-19
Republican members of the HELP Committee focused their questions on enhancing transparency in federally funded research, with many criticizing the Biden Administration's response to the COVID-19 pandemic for sowing confusion and mistrust about vaccines and federal health institutions. Dr. Bhattacharya was emphatic throughout the hearing that he wants to implement policies to rebuild trust in the NIH, including by providing "good data" to inform patient health decisions and spreading NIH funding to "non-traditional" entities. His answers indicate the NIH may reform its grant application review process to prioritize research institutions working on topics that have been historically underinvested in, a priority for HELP Committee Chair Bill Cassidy (R-La.) as outlined in his 2024 NIH Modernization white paper.
Dr. Bhattacharya also advocated for prioritizing new scientific perspectives and research methods, mentioning in response to questions from Sen. Josh Hawley (R-Mo.) about the use of stem cells from fetal tissue that "products of science should be ethically acceptable to everyone." Fetal tissue research has previously been controversial though federal law prohibits abuses. Nonetheless, his response implies the NIH may move closer toward a federal funding ban on this or other research some find controversial.
Democratic members of the HELP Committee pressed Dr. Bhattacharya on efforts by the Trump Administration and the U.S. Department of Government Efficiency (DOGE) to reduce the size of the NIH workforce by firing probationary workers. Dr. Bhattacharya reiterated he wants to ensure all NIH workers "have the resources they need," underscoring that reduced staffing levels may be permanent. In addition, members pressed Dr. Bhattacharya on the Trump Administration's effort to cap indirect cost rates for NIH awardees, to which Dr. Bhattacharya stated he would "follow the law" on indirect costs but raised the potential for audits of NIH-funded research. Although the order to cap indirect cost rates at 15 percent is currently paused in court, his answer indicates the Trump Administration may pursue a backup option to reduce indirect costs.
FDA
Dr. Makary was pressed by both sides of the aisle for his views on various vaccines and medications approved by the FDA. Dr. Makary was asked by both Republican and Democratic members about recent cancellations of vaccine advisory committee meetings, as well as the approval of mifepristone. Though Dr. Makary did commit to reevaluate the cancellation of a recent Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting if confirmed, he indicated that the FDA should prioritize recommendations from U.S. scientists on influenza and other vaccines, stating that he does not believe the U.S. should simply follow recommendations of international health bodies. He did not commit to maintaining the approval of mifepristone or the current FDA-required Risk Evaluation and Mitigation Strategies (REMS).
Dr. Makary shared limited insights into his priorities within drug approval processes if confirmed as FDA Commissioner, stating he supports regulatory pathways that are customized for specific disease states and indications. He noted rare diseases with limited patient populations may not need to complete multiple clinical trials and emphasized the importance of real-world data when considering new drug applications. Dr. Makary also highlighted that artificial intelligence (AI) could be used to improve drug development, streamline FDA operations and enhance market surveillance capabilities.
Dr. Makary made several notable commitments to committee members, including commitments to complete an assessment of the FDA's current staffing levels, improve the current pathway for approval of biosimilars and generic drugs "without cutting corners on scientific review," transition more products from prescription to over-the-counter (OTC) classification and reassess the current system for approving chemicals used in foods. On the latter, he noted the U.S. allows many products and ingredients to remain on the market that European nations do not. Similar to statements U.S. Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr. made during his confirmation hearing, Dr. Makary highlighted the generally recognized as safe (GRAS) standard as one that may require revisiting to ensure products that have been on the market for decades continue to be safe or require future additive ingredients to meet a higher regulatory threshold of safety.
Dr. Makary's commitment to members on these items increases the chances of new regulations or guidance being issued after his confirmation.