Califf: Advisory committee meeting structure needs an overhaul
Regulatory News | 14 February 2023 |
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FDA Commissioner Califf and moderator Kate Rawson
The US Food and Drug Administration’s (FDA) advisory committee system needs to be changed to allow fuller and more comprehensive discussion of the issues surrounding the approval of a medical product under review and should be less about the outcome, said FDA Commissioner Robert Califf.
Califf made these remarks at the Biopharma Congress meeting in Washington, DC on 13 February. During the meeting, which was moderated by Kate Rawson of Prevision Policy, Califf also renewed his call to fight rampant misinformation. He was asked to address his views on a wide range of issues, including the use of emergency use authorizations for COVID-19, recent reforms in the Food and Drug Omnibus Reform Act (FDORA) enacted last year and his long-term goals as commissioner.
Advisory committee reform
Califf said there is a need to revamp the advisory committee system to enable members to have “more space to meet and discuss the issues” with less emphasis on the vote, when asked his views on whether the advisory committee system needs to be reformed.
“The purpose of the advisory committee is not to produce gladiator votes, so people say the FDA does not agree with its advisory committees. The purpose is to get advice, and the best advice is not whether this drug should be approved. That decision should be made by full time civil servants,” he said.
Califf said that currently, time is “too compressed” and that the right experts might not be in the room for the meeting. He added that “the public deserves a full and fair discussion … I think we have lost a bit of that.”
The FDA chief also said that the purpose of these meetings is to provoke discussion and debate, and not always agree. He compared the advisory committee to a democracy, in that these meetings should “be messy” adding that “we should not always agree.”
Combatting misinformation
When asked whether the US won or lost the war against COVID-19, Califf responded that the US has both won and lost. While the country has won the technology battle, the country has lost the public health battle. “We won the battle to produce the vaccines and the COVID test,” but have not won the war on misinformation, Califf said, noting that while COVID vaccines have been proven to be safe and effective, millions of Americans have refused to receive them or stay up to date on their vaccinations.
Califf compared the disseminators of this misinformation to “snake oil salespeople who they can reach a billion people in ten minutes.”
When asked the major areas he would like to address before he leaves his job as commissioner, Califf joked that he can be “fired at any time, and my family would not be unhappy with that.”
Jokes aside, he said that combating misinformation and generating better higher-quality evidence to support product approvals are his two major priorities. “We have to fix both,” he said.
In other areas, he expressed disappointment that the Verifying Accurate Leading-edge IVCT Development (VALID) Act, failed to make its way into the user fee reauthorization package or into FDORA.
Biopharma Congress
Califf made these remarks at the Biopharma Congress meeting in Washington, DC on 13 February. During the meeting, which was moderated by Kate Rawson of Prevision Policy, Califf also renewed his call to fight rampant misinformation. He was asked to address his views on a wide range of issues, including the use of emergency use authorizations for COVID-19, recent reforms in the Food and Drug Omnibus Reform Act (FDORA) enacted last year and his long-term goals as commissioner.
Advisory committee reform
Califf said there is a need to revamp the advisory committee system to enable members to have “more space to meet and discuss the issues” with less emphasis on the vote, when asked his views on whether the advisory committee system needs to be reformed.
“The purpose of the advisory committee is not to produce gladiator votes, so people say the FDA does not agree with its advisory committees. The purpose is to get advice, and the best advice is not whether this drug should be approved. That decision should be made by full time civil servants,” he said.
Califf said that currently, time is “too compressed” and that the right experts might not be in the room for the meeting. He added that “the public deserves a full and fair discussion … I think we have lost a bit of that.”
The FDA chief also said that the purpose of these meetings is to provoke discussion and debate, and not always agree. He compared the advisory committee to a democracy, in that these meetings should “be messy” adding that “we should not always agree.”
Combatting misinformation
When asked whether the US won or lost the war against COVID-19, Califf responded that the US has both won and lost. While the country has won the technology battle, the country has lost the public health battle. “We won the battle to produce the vaccines and the COVID test,” but have not won the war on misinformation, Califf said, noting that while COVID vaccines have been proven to be safe and effective, millions of Americans have refused to receive them or stay up to date on their vaccinations.
Califf compared the disseminators of this misinformation to “snake oil salespeople who they can reach a billion people in ten minutes.”
When asked the major areas he would like to address before he leaves his job as commissioner, Califf joked that he can be “fired at any time, and my family would not be unhappy with that.”
Jokes aside, he said that combating misinformation and generating better higher-quality evidence to support product approvals are his two major priorities. “We have to fix both,” he said.
In other areas, he expressed disappointment that the Verifying Accurate Leading-edge IVCT Development (VALID) Act, failed to make its way into the user fee reauthorization package or into FDORA.
Biopharma Congress
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