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Science and Data Behind FDA Decisions, Says Commissioner

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Stephen Hahn told AdvaMed’s President and CEO Scott Whitaker during the Virtual Medtech Conference that FDA’s scientists have made decisions about medical products throughout the pandemic and will continue to do so.

In the weeks following his December 2019 start as FDA commissioner, Dr. Stephen Hahn said he learned an “important” point. "Trust the career scientists, trust the leadership of FDA—that has been a guidepost for me throughout the last year and has proven to be very, very helpful and effective as we’ve gone through what’s happened with COVID-19.

“Incredible expertise, a commitment to public health, protecting Americans, is within the DNA of FDA staff . . . and has helped us help the American public throughout the pandemic,” Hahn told AdvaMed’s President and CEO Scott Whitaker during Monday’s Virtual MedTech Conference livestream fireside chat.

“We basically doubled our work during the COVID-19 pandemic,” Hahn recounted. He pointed to the “fact that we maintained our goals for user fee agreements, we continued to approve new cancer drugs, got past the September deadline for tobacco applications and saw a significant decrease in use of e-cigarettes, at the same time responding to the pandemic. This is all due to the incredible career staff at FDA,” he said.

Whitaker asked Hahn about FDA’s vaccine approval process, pointing out that “some people are raising questions and skepticism about whether career scientists are still in charge.”

“Let me just be clear up front—our career scientists throughout this pandemic have made decisions about medical products and will continue to make those decisions,” Hahn said.

“When it comes to looking at data that we receive around a COVID-19 vaccine, and we have to make the assessment around safety, effectiveness, quality manufacturing, those decisions will be made by the career scientists and staff with the Centers for Biologics Evaluation and Research,” he added. “I can give input, but I like other previous commissioners have delegated that authority to the centers, and we have processes in place to make sure that the centers are protected from any outside pressure and that they are focused solely on looking at the science and the data.”

Hahn also touched upon agency priorities he had established before the pandemic and whether they had “to be put aside” during the response:

  • Empower consumers, get feedback, and include patient voice in decisions.
  • Unleash the power of data.
  • Stimulate choice and competition through innovation.

“What’s really interesting about those three strategic priorities for the agency—every one of them has become important during the COVID-19 pandemic, and every one can relate back to medical products like vaccines,” Hahn told Whitaker. “Particularly around the data issues, but definitely empowering the consumer, because your point about the questions . . . gets to the very heart—are we listening to the consumer, what are their fears, what are their concerns, and how do we address those.”  

In explaining the vaccine review process, he explained that a data safety monitoring board “looks at trial data at certain time points, and that there are prespecified criteria. Those criteria should be informed by the guidance we issued on June 30, which outlined what we at FDA need from a data point of view for safety and effectiveness. When those sponsors, the manufacturers, and the data safety monitoring board determine that the data are mature, that’s when they’ll turn to FDA with an application. So, FDA is not involved in that decision making—that’s an independent decision." He added that the agency provides technical assistance and that its scientists "will look at the data and examine it for safety and effectiveness" as well as "for manufacturing and quality.”

Hahn said that when the vaccine and biologics advisory committee convenes to review clinical trial data, it will be an open session for the public to attend and comment on. “We have to protect confidential commercial information . . . but our intention is to have this be an open process for everyone to see,” he said. He has been asked whether COVID-19 vaccines would be approved under EUAs or BLAs, and he said it would depend upon the sponsor’s application.

“The final point here is that our decision and what we made clear is that we expect to see safety and effectiveness data from at least one randomized phase III clinical trial—vaccine versus placebo—that shows data in a clear and compelling manner.”

Whitaker remarked on “the importance of public-private collaboration” and the value that the public sector and private sector have “in working together to get solutions for the American people particularly during a crisis.”

Hahn said that “we would not have been able to get the medical products we’ve gotten out to the American people as a country without that public-private partnership. . . . When you take ventilators, the industry partners that just stepped into the area that had never manufactured a ventilator before and stepped up to the plate to actually construct, develop, and create ventilators. And now we have many thousands in the Strategic National Stockpile—we are very well protected from a ventilator point of view. But you can go down the list—personal protective equipment, diagnostics tests—where the partnership that was in place, the dialogue that occurred, the urgency that everyone felt—again it is very similar to what I’m talking about vaccines. Nobody was talking about cutting corners, everyone was talking about how we work together to get to the right place, understanding that the science and the data had to be behind it in order for FDA to authorize moving forward.”

Hahn said that CDRH has “issued many hundreds of EUAs across the medical products spectrum” and has “many hundreds still in the pipeline,” and “we have learned a lot as an agency during the pandemic,” Hahn said. “A lot of it we have learned in dialogue with stakeholders such as AdvaMed and others.” 

Wrapping up the chat, Whitaker asked whether Hahn could speak about timing for a vaccine. Hahn said he could not “speculate,” and that it depends upon when the data are mature data from a phase III randomized trials. “We are looking forward to receiving applications, but from a timing perspective, I don’t have a crystal ball and cannot predict it.”

Whitaker said that “I think most people on this virtual conference will say, ‘we’re grateful that you are relying on the science and data to guide decision-making, because at the end of the day, the American people have to have confidence that the vaccine will work. And if they have that confidence, it will be a success process.’ ”

Watch the video for more insights from Hahn such as lessons learned during the pandemic response and on MDUFA here, and catch livestreamed sessions of the The Virtual MedTech Conference through October 7 and on-demand sessions through October 23.

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