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Duke-Margolis Center director defends FDA vaccine approval process in House hearing

<p>Former FDA Commissioner Mark McClellan spoke on Wednesday to the House Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce.</p>

Former FDA Commissioner Mark McClellan spoke on Wednesday to the House Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce.

Mark McClellan, founding director of the Duke-Margolis Center for Health Policy and professor of the practice of business administration, spoke on Wednesday to the House Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce as part of a panel of public health scholars. 

McClellan and the other witnesses fielded questions from representatives about the integrity of the U.S. Food and Drug Administration vaccine approval process and the politicization of public confidence in a future COVID-19 vaccine.

At the hearing, McClellan, a former FDA commissioner, drew on his experience as commissioner during the first major coronavirus outbreak, of SARS, to state his confidence in the approval process.

“Throughout my career, I've experienced firsthand the integrity, expertise and commitment of the FDA’s career staff, particularly in responding to public health emergencies,” McClellan said. “The vaccine experts and the biologics center are globally respected for their decades of experience in overseeing all aspects of vaccine development, manufacturing and post-market monitoring.”

McClellan praised the Trump administration’s Operation Warp Speed response, noting that it has converted what is “typically a long and uncertain sequential development process” into a shorter one by conducting clinical trials and scaling up manufacturing simultaneously. 

He said, however, that statements from the White House implying that the FDA’s plan to release additional written guidance on its expectations for Emergency Use Authorization is “unnecessarily raising the bar” are not true.

“Congress designed the Emergency Use Authorization process to provide FDA with exactly this flexibility to set standards that are appropriate for the different contexts that arise during the pandemic. All of these well-established systems for vaccine safety and effectiveness are hard to disrupt, and they have kept the COVID vaccine development process robust and on track,” he said.

Though Warp Speed is accelerating the pace of vaccine development, a process that McClellan recognized “makes people nervous,” he stressed the FDA’s role: To “make sure we're not cutting corners on the safety and effectiveness evidence.”

The committee further discussed the public’s loss of confidence in the vaccine approval process. McClellan said that despite recent political actions, the process of approval at the FDA requires intense regulatory oversight that is “not an easy process to disrupt.” The process, he said, involves the federal agency and an entire system of regulatory oversight and scientific expertise.

“The data safety monitoring boards, which [the National Institutes of Health] is generally involved in for these trials, the NIH expertise… [Centers for Disease Control and Prevention] expertise and CDC drawing in a whole set of independent experts for their Advisory Committee on Immunization Practices, which will also provide a review as part of this well-established process. It is a system like no other in the world,” he said.

While McClellan refrained from speaking explicitly about politics, stating, “The more we can keep the politics out of this, the better,” other witnesses on the panel were less circumspect. 

“I don't understand why we're having this meeting, to be honest with you,” said Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia. “We shouldn't need this meeting because we should trust the FDA. We don't trust the FDA, largely because of what has happened with the administration's pushing the FDA to do things it shouldn't have been doing.”

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