Senate Urged to Question Overton on FDA's Scientific Decision-Making

An upcoming Senate hearing on FDA commissioner-nominee Heidi Overton's confirmation should examine how she intends to make regulatory decisions, including her commitment to scientific evidence, transparency and established agency procedures, according to Steven Grossman, who previously held senior positions in the Senate and at HHS and is now the author of the FDA Matters blog (www.fdamatters.com).

In a 9/22 column, Grossman urged Senate Health, Education, Labor, and Pensions Committee chairman Bill Cassidy (R-LA) to look beyond individual policy controversies and focus on the decision-making principles Overton would apply in leading FDA.

Grossman said Overton is likely to face questions about vaccine policy, mifepristone, the Make America Healthy Again food agenda, her management experience and the degree of FDA independence from HHS and White House directives (see earlier story). However, he argued that the committee should also examine how Overton would ensure that FDA decisions are grounded in scientific evidence and that the agency clearly communicates the reasoning behind its regulatory actions.

Grossman proposed that Cassidy ask Overton whether she agrees that FDA should use science-based decision-making, how she would implement that approach and whether she believes the agency should be transparent about how and why it reaches particular decisions. The questions reflect Grossman's concerns about FDA's recent regulatory practices. He criticized Overton's predecessor for what he characterized as decisions made without adequate consideration of evidence or adherence to established agency procedures.

Grossman argued that departures from established review practices and public notice requirements have contributed to uncertainty among patients, consumers and regulated industry about the basis for FDA decisions. He cited public health advocate Paul Kim, who expressed concern that a lack of transparency can make it difficult to distinguish legitimate scientific and regulatory reasons for a drug rejection from potential political considerations.

Grossman emphasized that FDA's credibility depends on its willingness to consider differing perspectives, issue guidance explaining its regulatory expectations and publicly communicate the scientific and regulatory basis for its decision.

Meanwhile, former FDA commissioners Scott Gottlieb and Mark McClellan say Overton has an opportunity to strengthen the agency's scientific capabilities, restore regulatory stability and support biomedical innovation, while emphasizing that career scientists and physicians must remain responsible for regulatory review decisions.

In a 9/22 opinion column published in STAT, Gottlieb, who led FDA from 2017 to 2019, and McClellan, who served as commissioner from 2002 to 2004, expressed support for Overton ahead of her 9/ 24 confirmation hearing

The former commissioners said Overton's White House policy experience and relationships with administration officials could help her coordinate regulatory initiatives across federal agencies. They cited her work during the initial COVID-19 response and her experience implementing health policy reforms.

Gottlieb and McClellan emphasized the importance of maintaining FDA's scientific expertise as biomedical innovation accelerates, particularly in gene and cell therapies, artificial intelligence and other emerging technologies.

They also pointed to China's expanding clinical research capabilities, noting that more Phase 1 clinical trials now begin in China than in the United States. They argued that strengthening FDA's regulatory expertise and clinical development capacity will be important to maintaining U.S. biomedical innovation.

The former commissioners said recent FDA leadership decisions suggest an emphasis on continuity following turnover in the agency's drug and biologics centers. They stressed that the FDA commissioner and political advisers should not participate directly in individual application reviews, which should remain the responsibility of the agency's career scientific and medical staff.