The top spot at the FDA remains vacant, and the change in presidential power has some healthcare observers wondering about possible changes for the regulator. One month removed from serving as FDA commissioner, Robert Califf says the agency can be improved through a combination of precedent, experience, and evidence.
Califf, who served less than one year as FDA commissioner, made his comments in an address to the CED Life Sciences Conference in Raleigh, NC, on Tuesday. Mark McClellan, FDA commissioner from 2002 through 2004 under President George W. Bush, later spoke at the conference in a separate keynote. Though Califf and McClellan served at the FDA under different presidents, they now share a campus. Califf has returned to North Carolina as a professor at the Duke School of Medicine; McClellan is a professor of business, medicine, and health policy at the university.
Califf did not mention President Trump or comments he has made about cutting red tape, speeding up drug approvals, and slashing drug prices. (Both keynotes took place before the president addressed Congress Tuesday night.) Califf did acknowledge shortcomings of the agency, saying that the system regulating drugs and medical devices is “far from perfect” and needs to adapt to a changing world. But he said that the way to improve the FDA is to work with what’s already there. Califf noted that the American legal system defers to the FDA as a science-based organization. If political appointees approach drugs and devices from a political perspective, that deference would be lost.
“Every decision would be opened to reinterpretation by lawyers,” he said.
McClellan acknowledged the challenges and uncertainty facing the FDA. But he also pointed to opportunities for the agency. As an example, he referenced the 21st Century Cures Act, a wide-ranging law passed last year with bipartisan support. The law bolsters federal funding for biomedical research at the National Institutes of Health, and aims to speed up the regulatory review of new drugs and devices, among other provisions. To achieve those objectives, the FDA will need to hire more people, McClellan said.
Advances in technology are making the job of regulating medical products more complex. Califf noted that the convergence of information technology with traditional devices is spawning combination products that are more difficult to review. That complexity is also evident in … Next Page »