Last week, the U.S. Senate held confirmation hearings for Jay Bhattacharya, MD, PhD, as director of the National Institutes of Health (NIH) and Martin Makary, MD, MPH, for commissioner of the Food & Drug Administration (FDA).
Both nominations have the potential to significantly impact federally funded healthcare research, federal responses to public health emergencies and federal regulation of drugs and medical devices. Barring any unforeseen circumstances, both are expected to be confirmed to their respective appointments.
National Institutes of Health
In his opening statement, Dr. Bhattacharya outlined his five goals if confirmed to lead the 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; and
- Limit risky research in a nod to controversies over the origin of COVID-19.
Of note, the hearing was held in the wake of the Trump Administration’s recent moves to freeze NIH funding, cut the NIH workforce and cap indirect costs for NIH grants at 15%. Amid questioning from members of the Senate Committee on Health, Education, Labor and Pensions (HELP), Dr. Bhattacharya emphasized 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. He also reiterated he wants to ensure all NIH workers “have the resources they need,” and stated he would “follow the law” on indirect costs but raised the potential for audits of NIH-funded research. These are indications that reduced staffing levels may be permanent and that the Trump Administration may pursue a backup option to reduce indirect costs.
Food & Drug Administration
At his hearing, Dr. Makary distanced himself from recent high-profile disruptions at the agency, while also reassuring lawmakers that, if approved, he would continue the FDA’s tradition of following good science. He made several notable commitments to committee members, including commitments to complete an assessment of the FDA’s current staffing levels and to improve the current pathway for approval of biosimilars and generic drugs without cutting corners on scientific review. He also highlighted that artificial intelligence could be used to improve drug development, streamline FDA operations and enhance market surveillance capabilities.
Further, Dr. Makary stated he would reevaluate the cancellation of a recent Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting. He also hinted that the FDA should emphasize the input of U.S. scientists on vaccines, thus limiting the impact of international health bodies on FDA decision making related to vaccines.
Summary
The HELP Committee will vote on March 13 to advance both nominations to the Senate floor for confirmation. Both nominees are expected to be confirmed. The confirmation hearing for CMS nominee Mehmet Oz, MD, MBA, will be held on March 14. The ACR is steadfastly committed to ensuring that the NIH and FDA remain science-based, transparent and accountable to the public. For further information about the ACR’s regulatory advocacy efforts, email the ACR’s advocacy team at [email protected].
