Califf Praised As 'Thoughtful' Choice To Lead FDA

After months of growing speculation, President Barack Obama on Sept. 15 made it official – declaring his intent to nominate Robert Califf as the next commissioner of the FDA.

Califf's nomination, which was immediately praised by many in the biopharmaceutical research and development community, must be confirmed by the U.S. Senate before he can take the reins of the agency.

Sen. Lamar Alexander, chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee, which has jurisdiction over the FDA, called Califf's credentials "impressive."

Alexander said he would ensure the HELP Committee would move "promptly" to consider Califf's nomination.

Francis Collins, director of the National Institutes of Health, said he was "absolutely delighted" with President Obama's "ideal" choice to lead the FDA.

"Rob is a renowned leader in the biomedical community, a stellar researcher, a skilled administrator and a visionary who really knows how to get things done," Collins told Scrip in a statement.

The Pharmaceutical Research and Manufacturers of America (PhRMA) said it supported having a permanent commissioner for the FDA, but did not comment on Califf's nomination specifically.

If confirmed, Califf will be heading an agency in the midst of more transition as the sixth round of the Prescription Drug User Fee Act (PDUFA) converges with Congress' latest attempt to overhaul the agency as part of a larger bill to revamp the U.S. biomedical enterprise – doubling the challenges for any commissioner – and therefore, he will need to be able to negotiate with PhRMA and the other drug industry groups.

Califf, a cardiologist and former vice chancellor of clinical and translational research at Duke University, already has been at the FDA since February after being appointed deputy commissioner for medical products and tobacco.

The move into that job, which was first revealed in January, got the Washington rumor mill going that Califf was a sure bet to be the next FDA commissioner – with many in the biopharmaceutical research and development community assuming he was brought into the agency early to get him ready to be chief pending the likelihood Margaret Hamburg would step down, which she did in early April.

Tony Coles, CEO of Yumanity, who was one of Califf's medical students in the coronary care unit at Duke in the 1980s, said he was not surprised at all by President Obama's choice.

"I liked him immediately, and more importantly, respected him immediately," Coles told Scrip. "He always had the highest degree of integrity and with a real bend towards the scientific truth. I've always admired that he really understands the issues and that he works hard to uncover the scientific truth and what's the best, most balanced and wise decision in matters of health and health policy."

Coles praised Hamburg for "being thoughtful about putting in place a mechanism by which a smooth transition could occur."

"Dr. Hamburg saw in Rob Califf what we've all seen for so many years, which is that he really does understand, not just the technical aspects of clinical trials and the interpretation of data, but how to translate that information into balancing risk and benefit. And that's one of the most important jobs any FDA commissioner has to do," Coles said.

He said Califf's job as deputy commissioner, where the FDA said he's been providing executive leadership to the drug, device and tobacco centers and oversees the agency's Office of Special Medical Programs, was a big hint that Hamburg was "taking a lot of very good care in thinking about how the agency could extend the legacy she left."

Coles insisted that Califf was prepared to handle any situation that confronts the FDA and was capable of "reasoning his way through and then building consensus."

"He's the perfect person to lead the agency at this moment and be responsible for the safety of Americans," Coles said. "It is not an easy job, but I honestly cannot think of a better person to do it today than Rob Califf. We have some important challenges ahead in delivering outstanding health care to Americans paved with scientific innovation. I think the thoughtful, wise expert as Rob is, is exactly the profile of a commissioner who can navigate these waters years ahead."

"Rob understands that getting new medical products from discovery to patients requires all sectors – academia, industry, government, clinical care, nonprofits and patients – to work together throughout the research and development process," said Margaret Anderson, executive director of the nonprofit R&D advocacy group FasterCures.

She praised Califf's "steadfast commitment" to integrating patients’ perspectives into regulatory decision-making.

Jump From Academia To Government

At Duke, Califf's roles included serving as the director of the university's translational medicine institute. He also was a professor of medicine in the division of cardiology at the school's medical center in Durham, N.C.

Califf also was the founding director of the Duke Clinical Research Institute.

In addition, he previously was the editor-in-chief of American Heart Journal – the oldest cardiovascular specialty journal.

Before joining the FDA, Califf had an established history with the agency – serving on its Cardiovascular and Renal Drugs Advisory Committee, where he was known to often spar with fellow member Steven Nissen, head of cardiology at the Cleveland Clinic in Ohio.

This past July, Califf said his perspectives about a lot of things had changed since joining the FDA after spending decades in academia – declaring that his eyes had been opened to the impact PDUFA has had on the drug development and regulatory processes and the role various stakeholders, including the patient advocacy community, play.

"As a relatively newcomer to the FDA, I'm actually almost overwhelmed with the importance and the magnitude of the PDUFA process, in particular," Califf said on July 15 at a public meeting the US agency was required under law to hold to gain input before starting the negotiating process with the biopharmaceutical industry on the sixth user fee round, which would run from 2018-2022.

At that July PDUFA VI meeting, Califf made a point of thanking Stephen Ostroff, the current acting commissioner of the FDA, who took the reins in early April after Hamburg departed after nearly six years on the job.

That hat tip to Ostroff on July 15 led some to believe the two men's roles were about to change.

Ostroff previously was the FDA's chief scientist – a job he held for only about a year before taking on the lead role in a temporary capacity.

Ostroff had joined the FDA in 2013, taking on the role of chief medical officer at the agency's Center for Food Safety and Applied Nutrition. He came to the FDA from the Centers for Disease Control and Prevention (CDC), where he was the deputy director of its National Center for Infectious Diseases.

The University of Pennsylvania School of Medicine-educated physician also previously served as the acting director of CDC's Select Agent Program, which oversees the possession, use and transfer of biological select agents and toxins that have the potential to pose a severe threat to public, animal or plant health or to animal or plant products.

Cures/PDUFA Crash

Ostroff has been the person leading the PDUFA VI efforts and stepped into his acting role just as the House was at the height of trying to get the 21st Century Cures Act across the finish line, which it did in July. The Senate is expected to unveil a draft of its companion bill sometime this fall.

With it unclear how soon Califf can be confirmed – or if he will be, given there's always the potential something could be uncovered during the confirmation hearing process as lawmakers delve into the candidate's personal and professional finances and other details, which could derail the nomination – Ostroff will likely continue to be at the helm of the PDUFA VI negotiations and biomedical bill activities for the FDA.

But Califf is likely to be right at the acting commissioner's side as the FDA deals with the crash of those major legislative actions. And if installed as commissioner, Califf will be left to sort it all out – trying to figure out how to implement what's likely to be multiple provisions with undoubtedly not enough funds.