FDA nominee Robert Califf must prove his independence from industry

This weekly column offers opinions on the latest pharmaceutical industry news.

As a US Senate committee meets on Tuesday to consider Dr. Robert Califf for the top job at the Food and Drug Administration, an open question remains whether he is biased toward industry.

Califf is held in high regard by drug makers and academics alike. A cardiologist by training, he spent years as a professor at the Duke University School of Medicine and is one of the most influential biomedical authors in the world. He’s also run numerous clinical trials and served on various FDA advisory committees.

But ever since Califf was named a deputy commissioner at the FDA in January and then nominated to be chief regulator in September, his long-standing working relationship with the pharmaceutical industry has prompted debate. Among those opposing his nomination are Democratic presidential aspirant Bernie Sanders and Public Citizen, a consumer advocacy group.

Califf was the founding director of the Duke Clinical Research Institute, which conducts studies for companies. Last year, six drug makers — including Merck and Novartis — partly supported his salary, and several others paid him for consulting work. He has also authored numerous papers with industry researchers. No other commissioner in the recent past has held such close ties to pharmaceutical manufacturers. (The last commissioner, Margaret Hamburg, for example, was a career public health administrator.)

All this has led some to challenge whether Califf can be an honest broker.

“I do think hard questions should be asked,” said Daniel Carpenter, a Harvard University political scientist, who has studied the FDA but has not taken a position on Califf. “He will have a fair amount of power to push for change.”

Of course, interacting with drug manufacturers is a vital part of the regulatory process. So possessing an intimate knowledge of industry procedures and the medicine-making machinery should certainly be a plus. In this way, Califf may be a smart choice.

What’s more, Califf may be better equipped to stand up to companies in the event of a dispute. Drug and device makers often complain the FDA doesn’t understand their needs, but that would be much harder for them to argue with Califf in charge.

“The country needs a strong and experienced leader who can keep the FDA focused on its mission,” Dr. Jeffrey Drazen, the editor-in-chief of The New England Journal of Medicine, wrote in an editorial last month urging the Senate to confirm Califf “as quickly as possible.”

The nomination comes at a pivotal time for the FDA. The agency is under increasing pressure from drug companies and patients to approve more medicines faster than ever. Congress is considering legislation designed to accelerate innovation, although some critics say the effort threatens to lower safety standards for approving some products.

This helps explain why a May 2014 presentation Califf made in Durham, N.C., has suddenly gained attention. On the second-to-last slide of a talk given to a group of biomedical researchers, lawyers, and industry experts, he wrote that government regulation is a “barrier” to innovation.

The presentation passed without notice at the time, but the slide deck is now circulating online as pundits chatter about Califf’s motivations. Some interpret the phrase to reflect his feelings about the agency and its role. Whether this view proves too simplistic remains to be seen.

A spokesman for the US Department of Health and Human Services, the parent body to the FDA, explained that Califf believes that federal drug regulators need to be as creative as possible, which creates an “inherent tension” in fulfilling its mission. He added that Califf has displayed the same slide in other presentations, and also noted that Califf donates his consulting fees to charity.

Still, Califf’s views toward FDA oversight are potentially worrisome.

After all, it’s one thing to advocate for change so that the FDA becomes more effective. It’s another thing to suggest that regulation, which is the agency’s raison d’etre, is an impediment to progress. More than just vetting the effectiveness of new products, the FDA is also chartered with ensuring safety.

Then there was a puzzling episode earlier this year. Califf recently coauthored three scientific papers that, in part, criticized the FDA’s oversight of clinical trials. But, as STAT reported last month, after he joined the agency, Califf asked that his name be removed before publication, which ran afoul of standard publishing procedures and ethics.

Perhaps Califf thought twice about airing his views, since an FDA commissioner is expected to adopt a more measured approach. Whatever his rationale, he provided still more fodder for his critics.

“It certainly gives the impression that Dr. Califf wanted to hide opinions he had previously planned to take credit for,” said Diana Zuckerman, who heads the National Center for Health Research, a think tank in Washington, D.C. “This is a serious error of judgment.”

Certainly, Califf has much to offer. Given his credentials, he can infuse the FDA with insights and experience that might otherwise be hard to come by. But overlooking his long-standing ties to industry — and the impression that he may be aligned with their interests — would be a mistake.

The Senate Committee on Health, Education, Labor, and Pensions should ask tough questions on Tuesday about Califf’s willingness to balance cries for relaxed regulation with an ongoing need to protect public health. Califf may well be qualified to lead the FDA, but he must demonstrate that he is truly independent.