By AMERICAN HEART ASSOCIATION NEWS

Robert M. Califf approved as commissioner of the FDA

Robert M. Califf, M.D., Commissioner of the Food and Drug Administration

The Senate voted 89-4 on Wednesday to confirm Robert M. Califf, M.D., as commissioner of the Food and Drug Administration, ending a long and contentious confirmation process.

Califf is a globally recognized leader in cardiovascular medicine and currently serves as FDA’s deputy commissioner of medical products and tobacco. Before beginning his service at FDA, Califf served as the founding director of the Duke Clinical Research Institute. As a member of the American Heart Association, Califf assisted with the design of a community program in the state of North Carolina that helps residents maintain a healthy blood pressure through regular monitoring and guidance from health care professionals.

Califf was nominated by President Obama in September of last year, but faced questions by lawmakers about his work with pharmaceutical companies while serving at the clinical research center, which delayed his confirmation. In addition, several senators used the nomination process to begin a national conversation about the FDA’s regulation of opioids and the agency’s response to the nationwide opioid epidemic, further delaying the vote.

Despite the delay, Califf was confirmed with widespread support from lawmakers on both sides of the aisle.

“I think the fact that 89 Democrats and Republicans voted ‘yes’ and four voted ‘no’ tells you that it works – people saw that you can have integrity with a long history of working with industry,” Califf told the AHA’s Board of Directors on Wednesday night.

Califf briefed the board via telephone about the FDA’s priorities promoting and protecting the public health. He also fielded questions.

“I think it’s a great time in our country and around the world for medical science,” Califf said. He cited an “explosion” in biomedical science and a radical change in information technology as key reasons for his optimism.

One aspect of biomedical science that Califf said excites him is not typically categorized as science – social media.

“We’re really driven by centering on what we can do for patients and consumers,” he said. “With social media, we have this amazing opportunity to go directly to people and find out what they’re thinking, what their issues are, how they are doing and directly collect data about risks and benefits of products.”

His first day in his new position was spent discussing several issues that the AHA is deeply involved in, including precision medicine and tobacco regulation. The FDA has been trying to figure out for some time exactly which tobacco products to oversee, while the agency also is expected to release new regulations governing e-cigarettes sometime this year.

“Our goal is to as quickly as we can reduce deaths and disability from tobacco,” he said, adding that the growing electronic cigarette industry is a major concern. “The data are coming in very fast that more teenagers are starting on e-cigarettes every month, so we’re anxious to get this under control.”

On Thursday, Califf was headed to the White House for a meeting on precision medicine – which was also a key topic of discussion at the AHA’s Board meeting; the AHA has recently launched the Institute for Precision Cardiovascular Medicine.

These efforts rely on vast amounts of genetic data for research aimed at more personalized treatments and prevention strategies, and Califf said he’s confident that people will participate to help build out such studies.

“If you look at recent surveys of Americans, including focus groups, the vast majority of Americans want their data to be used for research,” he said. “In return, they want to make sure they are being used by responsible people, and they’ll get something in return through the research.”

Earlier Wednesday, AHA chief executive Nancy Brown praised Califf’s appointment.

“His dynamic résumé makes him a triple threat when it comes to combating public health problems in this country,” she said.

His “experiences, combined with his commitment to improving the health of our nation that make him a perfect fit for this role. Americans will greatly benefit from his expertise and his unique ability to work with all stakeholders,” she added.