WASHINGTON – The doctor who will likely head the U.S. Food and Drug Administration promised a new, more robust system for monitoring the performance of medical devices.
Dr. Robert Califf told senators at a confirmation hearing Tuesday that he wants to extend a system now used to measure drug performance to the device industry to address a current lack of information about how well FDA-approved devices function.
“The Sentinel system is a model in drugs,” Califf said. The system includes “over 170 million Americans’ claims data. So when there is a problem with a drug, we can work on it in real time. We need the same system on the device side. We have plans to do that.”
But Califf said the FDA would have to work with Congress on how to pay for the expansion of device safety reporting.
Questions of device safety, drug costs and industry influence on drug and device approval dominated the two-hour hearing. But only one member of the Senate Health, Education, Labor and Pensions Committee — Democratic presidential candidate Bernie Sanders — opposed Califf’s nomination.
Sanders said he did not believe Califf, a cardiologist whose medical research has sometimes been funded by big drug companies, would be aggressive enough in trying to lower medication costs.
Other committee members, including Democratic Sen. Al Franken of Minnesota, did not challenge Califf’s fitness to serve as FDA commissioner.
Still, plenty expressed concern about expensive prescription drugs, the time it takes for approval of cost-saving generics, food labeling, lack of public information, burdensome regulations and the ability of the device and drug industries to control research studies they pay for.
Sen. Elizabeth Warren, D-Mass., told Califf that his “financial relations with industry raises questions.” Warren asked Califf to provide proof that he had never altered research at the behest of corporate sponsors.
In response to several senators’ questions about the objectivity of corporate-sponsored research and consulting fees paid to researchers, Califf pointed to policies in place at Duke University, where he worked before coming to the FDA. He held them up as a model for how industry and academia could coordinate while maintaining the integrity of the research process.
“The database [of raw data] is really the critical factor here,” Califf said. “In all of our contracts we require that we have access to the database. So we actually have the database on site. That’s been ironclad.”
Califf said he had been unable to do 70 percent of the corporate-funded studies he wanted to do because companies refused to grant him the right to independently access and publish databases.