FDA’s Marks weighs in on adcomm reform

The US Food and Drug Administration’s (FDA) advisory committee system needs reform, but Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) still sees value in allowing those outside experts to vote on whether to recommend approval of biopharmaceutical products. Marks made his comments at a meeting held by Politico.

FDA Commissioner Robert Califf has repeatedly stated that the agency’s advisory committee system needs reform and has even said that he doesn’t find the votes that external experts take on whether to recommend a product to be useful (RELATED: Califf tells stakeholders to stay tuned for advisory committee reform, Regulatory Focus 18 May 2023).

“Part of the problem is, especially when dealing with rare diseases, it's hard to find non-conflicted experts,” said Marks. “The other issue is it's very challenging to give someone a hundred pages and say read this and become an expert on this when they have a week to do so.

“I think we do need to try to find ways to do this better and it's not because our advisors aren't good, it's because of the complexity of what we're dealing with,” he added.

FDA is currently allowed to waive conflicts of interest for panel experts, allowing them to participate despite those conflicts.

“I think in certain cases it’s helpful to have voting,” said Marks. “For instance, in the case of the [COVID-19] vaccines, the fact that there were votes that were unanimous was actually helpful in reassuring people who may have felt anxious about the vaccines.”

Marks isn't the first FDA official to express support for the status quo regarding advisory committee recommendations. Richard Pazdur, director of the Oncology Center of Excellence, told STAT recently that it helps the agency take a pause in some cases before making a final decision.

Marks also addressed pending legislation that would improve CBER’s capacity to address future pandemic and counterterrorism preparedness.

Earlier in the day, the Senate Health, Education, Labor, and Pensions (HELP) Committee passed a bill reauthorizing the Pandemic and All-Hazards Preparedness Act (PAHPA) that included an amendment to create a team within CBER that would be tasked with various activities to support the development and authorization of countermeasures to emerging pathogens. The team also would conduct surveillance of such countermeasures and activities to ensure the safety and availability of the US blood supply (RELATED: Senate HELP advances PAHPA reauthorization bill, Regulatory Focus 20 July 2023).

During committee discussions, Republican lawmakers argued that the FDA Office of Counterterrorism and Emerging Threats (OCET) works on countermeasure-related issues and that a second office was not needed.

Marks, however, said that during the pandemic, CBER had to reassign staff to help develop COVID-19 vaccines, backburnering work on other product applications. The new team would be able not only to tackle future crises but also actively look for signs of the next pandemic and respond faster, he said.

“The idea of this particular provision is to have a cadre of people who are always working in this area so that we are ready for the next one of these,” said Marks.

He also dismissed any notion that the next pandemic may be in the distant future and noted that before the COVID-19 pandemic, the world was dealing with endemics such as Ebola and Zika.

“These things are constantly popping up and rather than having to essentially reassign whole groups of people and disrupt things, the idea is to have a group of people who are constantly working on this,” said Marks, adding that the team also could be assigned to support the Department of Defense in developing vaccines and other products as needed.

FDA’s Marks weighs in on adcomm reform

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