FDA Commissioner Wants To Revamp The Evidence Generation System

FDA Commissioner Wants To Revamp The Evidence Generation System

July 18th, 2022 // 2:27 pm @

FDA Commissioner Rob Califf said last week that he wants to combat scientific misinformation and create new ways to increase the use of the evidence generation system that FDA relies on to make its drug approval decisions.

Califf referred to the agency as a decision-making machine and an organization that is ‘a referee that plays by a set of rules.’ Califf made it clear that in his next term as FDA commissioner, he will focus on embracing new data, which may be a look back to his work with the company Alphabet, which is owned by Google. He led the company’s policy and health strategy for two years.

Califf told the media that the agency’s delivery of evidence to support its decision making is a fraction of what it should be, given the technology that the US has access to. He said when there is enough evidence, there are still disagreements about how it should be interpreted. But he noted that things are very different when the agency must make a decision based on a user-fee mandate and the evidence is murky. He noted that is when there is another argument to be had there and it often doesn’t lead to the best possible decisions.

Califf said in three years’ time, he wants to have an FDA that is bolstered by better scientific evidence, as well as have a better strategy to combat scientific misinformation. He added that everyone in the US has an electronic health record that is full of data that can be used to conduct clinical studies at a low price. This is very important, he noted, with medical products, where approvals are often accelerated.

He noted that there is often a lack of evidence generation in the United States. For example, ‘who would think that we would need to rely on data from Israel for the fourth dose of COVID-19 vaccines?’

As far as the timeline for user fee reauthorization, which Congress is coming up against with the August recess deadline, he made clear that the FDA will lay off reviewers if the reauthorizations are not completed on time. He added that the FDA commitment to drug application review timelines for drug sponsors won’t be met if those funds are not available.

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