Ex-FDA commissioner Califf sees patient-groups, patient input as necessary to FDA’s future

The future of the FDA will depend even more on patient groups and patient input on drug evaluation, and will need to rely more on outside watchdogs to eliminate “imposters,” according to former commissioner Califf.

Califf, who resigned from his FDA post last week, spoke to a crowd in Silicon Valley early this morning about the future of the FDA and regulation in the industry.

“If I had a disease with an ineffective advocacy group, I’d be worried right now,” Califf said, according to an Xconomy report.

Califf did offer a caveat, though, saying that often patient groups receive funding from drug companies, and can end up being controlled by their funders interests.

On the topic of devices that use rapid incorporation of data and computation, Califf said the FDA would have to navigate some regulatory gray areas – giving an example of a defibrillator which uses computations to operate, which should be regulated, and a watch which measures heart rate, which would not need the same oversight.

In between the 2 devices though, Califf suggested that the agency should be lighter, according to the Xconomy report. “And I predict that we will have problems,” Califf added.

Califf also suggested that researchers in deep-knowledge fields, such as gene editing, may need “transparent sharing” so that, despite facing most likely shrinking resources under Trump, “imposters and non-truth-tellers,” will be able to be weeded out without the FDA being an investigative unit, according to the Xconomy report.

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