HELP Committee Considers Nominees to Lead NIH, FDA
This overview is excerpted from , Manatt’s subscription service that provides in-depth insights and analysis focused on the legal, policy and market developments. For more information on how to subscribe and to activate a complimentary one week trial to Manatt on Health, please reach out to .
On March 5 and 6, the Senate Health, Education, Labor, and Pensions (HELP) Committee held hearings to consider two of President Trump’s nominees: Dr. Jayanta Bhattacharya to serve as director of the National Institutes of Health (NIH) and Dr. Martin Makary to serve as commissioner of the Food and Drug Administration (FDA). These are the first health nominees to receive consideration in the Senate since confirmation of Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. last month, and both are expected to advance with bipartisan support.
Bhattacharya, currently a Stanford University professor of medicine, economics, and health research, answered questions from HELP members on the structure of and resource allocation at NIH, particularly from Republican committee members who broadly commended the administration’s efforts to trim excessive government spending. Democrats, on the other hand, focused their questions nearly universally on the NIH’s , announcing an immediate 15 percent indirect cost rate cap for go-forward expenses on NIH grants. The indirect cost cap is currently subject to a nationwide federal injunction issued on March 5 prohibiting its implementation but if fully implemented, the policy change would cut billions in biomedical research across the country. Though Bhattacharya noted that he was not involved in the indirect cost cap guidance or recent staffing or funding decisions at the agency, he said that the cap on indirect costs “reflects distrust in universities and the scientific process,” and NIH and its grantees must be more transparent in order to restore public confidence in NIH-funded medical research.
Makary, a surgeon at Johns Hopkins, faced a slew of questions from both sides of the aisle. Republicans criticized the decision under the Biden Administration to remove the in-person requirement for prescription of mifepristone. The nominee did not commit either to maintaining or rolling back the existing regulations but said he would examine the data. Additionally, Democrats criticized the recent layoffs at FDA, noting potential delays of FDA reviews, inspections, and approvals of medical products. Additionally, like Kennedy, the nominee faced questions on his beliefs on vaccines, particularly in light of the recent measles outbreak in Texas and FDA’s cancellation of the annual Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting. (Makary vowed to examine the rationale behind the cancellation of the VRBPAC meeting while also noting support for reevaluating the roles of FDA advisory committees generally.)
On March 13, the Committee is set to vote on both of these nominations during an and will also hold a to consider David Weldon’s nomination to be the director of the Centers for Disease Control and Prevention (CDC). Both Bhattacharya and Makary are expected to receive bipartisan support in their committee vote, which will virtually guarantee their confirmation by the full Senate. Following this HELP Committee activity, on March 14, the Senate Finance Committee will hold a to consider the nomination of Dr. Mehmet Oz, the president’s nominee to lead the Centers for Medicare & Medicaid Services (CMS).
For more information on how to subscribe and to activate a complimentary one week trial to , please reach out to .