Q&A: FDA Chief Califf Talks Clinical Trial Diversity, Using AI/ML For Inspections, User Fees, And More
The commissioner of the US agency, Robert Califf, answered questions on a variety of timely issues at a 12 July fireside chat. Here are three key takeaways for medtech.
Robert Califf, the commissioner of the US Food and Drug Administration, is concerned that a laser focus on ensuring diversity in clinical trials is a sideshow from the real problem: “lack of equity in our health care system.”
Speaking at a 12 July fireside chat sponsored by the Alliance for a Stronger FDA, the agency head said that if the disparity was fixed and health equity was ensured, “clinical trials will follow suit.”
“But having said that, …we’ll work hard on helping to increase diversity in clinical trials,” Califf added.
Below are three memorable questions answered by the commissioner during the chat. Questions have been edited by Medtech Insight for clarity and brevity.
I’ve noticed that certainly, in my life in Silicon Valley, people came and went fairly rapidly from one organization to another. And who wants to work in an organization if you’re afraid that these jobs are not even going to exist in the next short period of time? So we really need to avoid that. But in addition to that, we’ve got to consider the consequences for the public, for the American people. If the user fees are not funded, …we’ll review products as quickly as we can, but the timelines go away. And the commitment to the timelines goes away, because there’s no way you could meet those commitments. We wouldn’t have the people to do it.
…It’s just hard for anyone to believe that the user fees wouldn’t get passed, but it’s really important that we get them passed so that the transition into the next phase can occur without disrupting employment and function at the FDA.
“Machine learning and AI – I think one of the biggest uses by FDA in the near future is going to be to help us with inspections.”
And then the final thing is within FDA, we have work to do on equity, we have a shortage of people of color, and Hispanic people in the leadership roles at FDA. And so, watch for those, it’s going to be a very active effort on our part to diversify the workforce. And as we’re now living in a hybrid work environment, that means we can recruit from other places and include people who might not be able to move to Silver Spring, for example, and include them in the workforce so we got some real opportunity there.