Califf tells stakeholders to stay tuned for advisory committee reform

WASHINGTON – The US Food and Drug Administration (FDA) plans to reform its advisory committee system, and stakeholders should expect upcoming changes, FDA Commissioner Robert Califf said in a video presentation at the Food and Drug Law Institute (FDLI) Annual Conference.

FDA has nearly 50 advisory committees comprised of external experts, including academics, physicians, industry representatives, and patient and consumer advocates. The agency calls on them to discuss issues and make recommendations that can be exceptionally complex and sometimes controversial. While the committees provide their expert opinion to FDA, the agency is not obliged to follow their recommendations.

During his keynote speech, Califf outlined a full slate of activities the FDA undertook over the past several years while also addressing the COVID-19 pandemic. He argued that while the US has maintained its leadership role in getting medical products to market, the agency now must strengthen its structures, methods, data collection, and science to be even more efficient, flexible, and effective.

“As a former long-term advisory committee member, I believe strongly in the value of interchange among our experts at the FDA and experts who work outside the agency,” Califf said. “For certain complex issues, seeking the advice of an advisory committee not only makes our decisions better but also adds an element of transparent societal discussion that’s important.”

“But I also believe that our advisory committee system can be improved to enable our experts to get the best advice possible,” he added. “Stay tuned for developments in this area.”

In a blog post back in February, Califf used almost identical language to advocate for reforming FDA’s advisory committee system, saying that while he appreciates the system, it is “messy” and needs to be reformed.

The impetus for reform comes in part from the agency’s approval of Aduhelm (aducanumab-avwa), an Alzheimer’s disease treatment from Biogen, despite an advisory committee vote against recommending it (RELATED: FDA approves aducanumab for use in Alzheimer’s disease, Regulatory Focus, 7 June 2021).

Ultimately, three advisory committee members resigned over the agency’s decision; further, Billy Dunn, director of the Office of Neuroscience, who oversaw the controversial approval, retired from FDA service earlier this year (RELATED: Billy Dunn, FDA’s top neuroscience official to depart agency, Regulatory Focus, 27 February 2023).

Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), declined to comment on the internal discussions regarding advisory committee reform but noted that the agency wants to ensure that the right experts are selected for advisory committees.

“We want to make sure we are getting the top and appropriate experts on the panels, and in today’s world, many of those people might be conflicted out because of their involvement in product development,” he told Focus. FDA currently allows waivers for panel experts who may have a conflict of interest.

Califf indirectly addressed the Aduhelm decision and the data FDA has gathered since, noting that the new data could improve Alzheimer’s disease treatment.

“I also call your attention to two areas that are shaping up possibly to be major game changers in our ongoing battle with chronic diseases that are causing the vast majority of death and disability in our country,” Califf said. “We are awaiting final submissions, but if the submitted data matches up with the press releases, it is possible that we could see significant reductions in the rate of progression in Alzheimer’s disease.”

He also said new classes of drugs appear to have a major impact on obesity and diabetes that could have significant implications for treating chronic diseases.

“I want to stress again that we have to wait on the data, but both of these areas will raise major questions about the interface between approval by FDA for an intended use and broader use for tens of millions of Americans,” said Califf. “This is a good problem to have, and we are having productive discussions with our [Centers for Medicare and Medicaid Services] colleagues, for example, but we all need to be working on these issues.”

FDLI Annual Conference