Representatives from the medical device community are applauding President Barack Obama’s decision to nominate Robert Califf to be the next commissioner of the FDA.
“As one of the nation’s preeminent cardiologists, Dr. Califf understands the value medical technology brings to improving patient outcomes, and we look forward to working with him to ensure that American patients have timely access to the life-saving and life-enhancing innovations our industry provides,” says Steve Ubl, AdvaMed president and CEO, in an emailed statement to IDDM.
“As a long-time collaborative partner with the FDA on initiatives to promote the safe and effective use of medical imaging equipment, we look forward to ongoing cooperative efforts with the agency and Dr. Califf if he is confirmed,” adds Patrick Hope, executive director of the Medical Imaging & Technology Alliance.
To some, Califf always has been the obvious choice to head the agency. “When asked who was on my short list of potential commissioners, I said ‘Robert Califf is the short list,’” Peter Pitts, president and founder of the Center for Medicine in the Public Interest and a former FDA associate commissioner, tells IDDM.
Steve Niedelman, a former FDA official who now consults medical device companies, seconds that assessment, noting that Califf was a contender six years ago when Margaret Hamburg was nominated.
Not everyone has voiced support for Califf’s nomination, however. Michael Carome, director of Public Citizen’s Health Research Group, has urged the Senate to reject his nomination, citing Califf’s long history of financial ties to industry. “His nomination undoubtedly comes as welcome news to the pharmaceutical and medical device manufacturers, but is bad news for patients and public health,” Carome says in a statement.
Margaret Anderson, executive director of FasterCures and past president of Alliance for a Stronger FDA, is one of many who disagree with this assessment, telling IDDM that early in his tenure as deputy commissioner at the FDA, Califf spoke out about the science of patient input and related methodologies in clinical trials, a key focus of the 21st Century Cures Act.
Robert Harrington, chairman of the Department of Medicine at Stanford University, worked with Califf at Duke University for more than a decade, and says the nominee understands both the appropriateness of industry-academic collaborations and the necessary boundaries. By necessity, Califf has collaborated with research funders, including private industry, to plan and implement clinical trials, he says.
Pitts says Califf’s experience as deputy commissioner and his past dealings with FDA employees have earned the respect of senior agency staff.
If the Senate approves his nomination, Califf will come into his role as the agency is facing a number of challenges, including recruiting and retaining staff and assuming new responsibilities if the 21st Century Cures Act goes into effect. — Kellen Owings