FDA commissioner on drug approvals: The problem isn’t innovation or speed

There’s “no question” that the US is the top pharma innovator for the world, FDA commissioner Robert Califf said yesterday at the Milken Institute’s Future of Health Summit, but he also pointed to the falling life expectancy in the US, which is now five years shorter than some other high-income countries.

“The problem is not innovation and getting products out quickly. We’re not figuring out how to use them well,” Califf said.

Discussing the biggest upcoming opportunities for the FDA, Califf said “medical products are in good shape” after the passage of the user fee agreements. The “biggest area” for growth over the next five years will be in developing out FDA’s regulation of cell, regenerative and gene therapies.

The FDA’s office that regulates these advanced products is looking to add about 100 new experts, but competition with industry for top people is fierce.

“We’ve got jobs by the way,” he said of the agency’s new hiring funds. “You can see everything if you’re on the inside.”

Namandjé Bumpus

On the topic of diversity in clinical trials, which is something Congress sought to add to the user fee deals but then pulled out before passing them, Califf said the agency is working on a “manuscript,” pointing to new FDA chief scientist Namandjé Bumpus and Hilary Marston, FDA’s chief medical officer, as leaders.

“We have made a lot of progress,” he said. If you look at NIH-funded trials, “it looks pretty good,” Califf said, and if you look at FDA’s drugs snapshots, “it’s getting better.”

Geography is becoming more important, he noted, especially as rural areas lack the resources and access to medical specialties that their urban peers have better access to.

“It’s asking clinical trials to overcome a health system that created these disparities,” he said. “It doesn’t happen in a vacuum, it’s in the context of the health system we’re in.”

As far as the accelerated approval reforms that have been floated as a potential add-on to an upcoming congressional spending bill, he said the criteria and concept of the accelerated pathway is supported by the general public, FDA and Congress. But “where we miss is getting the follow-up studies done” and knowing which treatments are best.

Califf discussed the issues around accelerated approvals with OCE head Richard Pazdur last month, and previously called on Congress to address the reforms expeditiously.

On misinformation, a topic which Califf has highlighted as a priority for his tenure given the vaccine misinformation that’s spread quickly online, he said he can’t find anyone with a solution.

That’s resulted in risks to people who got their initial vaccines but stopped there.

“We are seeing increased deaths in those who have not gotten up to date,” he said.

He also called for the creation of a network of people dedicated to disseminating reliable information.

“There’s no question the social components are playing out,” he said.

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