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# Califf Says Evidence Generation is ‘Mediocre’ At Best
- URL: https://www.fdaweb.com/califf-says-evidence-generation-is-mediocre-at-best/
- Published: 2022-07-13T12:00:00.000Z
- Updated: 2026-09-14T17:51:42.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5152266

FDA commissioner **Robert Califf** wants to see evidence generation greatly improved during his tenure as the agency’s chief executive, a tenure that he foreshadowed will likely run through the end of the current Administration. Speaking during an Alliance for a Stronger FDA online fireside chat 7/12, Califf said today’s standards for evidence generation are “mediocre” at best, and opportunities are being missed to utilize electronic health records for demonstrating safety and effectiveness.

“I think we do a really good job of developing medical products up through the early phases, and that system works well,” Califf told the Alliance. “It’s very expensive, but it delivers a quality product. But if you ask the question ‘do we understand what the right doses of drugs are, how to use devices, how to combine and compare choices that we have to make with medical products?’ then I’d say we’re doing a lousy job of generating that evidence. And yet, everyone in the United States has an electronic health record packed full of data that could be used to do studies very inexpensively.”

Improved evidence generation is more important now, considering there is increasing use of the accelerated approval process and where such products have only been demonstrated to reasonably suggest the benefits outweigh the risks, Califf said. To illustrate the problem, he pointed to Biogen’s [controversial accelerated approval](https://www.fdaweb.com/uproar-greets-fdas-aduhelm-ok-for-alzheimers/) of Aduhelm (aducanumab) for treating Alzheimer’s patients and the company’s estimate that it will take nine years to do the follow-up confirmatory study. He acknowledged the public uproar that ensued due to such an unreasonable timeline. “And you’ve got to ask, you know, ‘what’s the system that would generate the evidence that we need for those sorts of post market studies?’” Califf continued. “It's simply inadequate.”

Asked what good evidence generation would look like, Califf said that for every medical product approved “we would understand the benefits and risks and understand how the product should be used in practice so that the labels were actually informative to the people that have to make the decisions.” To further illustrate the frustration the current evidence generation system in the U.S. creates, Califf pointed to the data used to support Covid-19 booster vaccines in the U.S.: “Who would have thought we’d have to depend on Israel to give us the information about the decision on the fourth dose of the vaccine? We just didn't have the data in the U.S to inform that decision. We’ve got to do better.”

Additionally, Califf said one of his top issues to address during his tenure is misinformation. “We’re losing a battle on misinformation,” he told the Alliance. “Now, it's not just an FDA issue. It’s a science issue in general, and an issue for all other federal agencies and clinical practices that people are being distracted by misinformation and disinformation.”

Before rejoining FDA, Califf said he spent considerable time at Google working to understand misinformation because it became clear that it was a growing issue. “We know a lot about misinformation,” he said. “We know how it’s generated. We know how it spreads. It really is a fact that for the most part misinformation travels faster and further than truthful information. I haven’t found a single expert, and I’ve had access to all of them, who has a solution to the problem that they think will work at this point, and we are losing that battle.” As evidence, he said misinformation has contributed to the U.S. ranking 67th in the world in terms of Covid vaccination status, and “most Americans should be mystified how that can be the case.”

Califf said all federal partners are interested in helping develop a strategy to deal with misinformation, but the federal government alone cannot solve the problem. “There’s too much mistrust already in the government,” he said. “We have a significant and very important role to play but we need all of you to be activated. We need a network of people who are committed to the promulgation of reliable, truthful information. And remember that the best antidote to someone who has been misled by information is an interaction with another human being that they trust, like physicians, pharmacists, nurses, and teachers.”