Will Robert Califf, cardiologist and founding director of the Duke Clinical Research Institute, become the next head of the FDA?

President Obama nominated Califf in September 2015, and he sailed through a Senate confirmation hearing in November. Earlier this month, the Senate Health, Education, Labor and Pensions (HELP) Committee voted unanimously to approve him.

But Califf finds himself hampered by Sen. Lisa Murkowski (R-AK), who has threatened a hold on Califf over the Obama administration’s approval of genetically engineered salmon, and Sen. Bernie Sanders (D-VT) who takes issue with Califf’s ties to the pharma industry.

“We need someone who will work to substantially lower drug prices, implement rules to safely import brand-name drugs from Canada and hold companies accountable who defraud our government. Dr. Califf is not that person,” Sanders said in a recent statement. “His extensive ties to the pharmaceutical industry give me no reason to believe that he would make the FDA work for ordinary Americans, rather than pharmaceutical industry CEOs.”

With red flags raised by a moderate Republican and a liberal Democrat, Califf—who has served as deputy commissioner of the FDA since early last year—has problems on both sides of the aisle. Also, a nomination by a Democratic president at the end of his final term, with a majority Republican house, could lead to Califf’s nomination floundering indefinitely.

Perhaps Sanders will change his mind. Sen. Elizabeth Warren (D-MA) previously had problems with Califf’s ties to the drug-development industry, but earlier this month announced satisfaction with Califf’s integrity as an academic researcher.

Califf’s ProPublica “Dollars For Docs” profile, it turns out, isn’t at all eye popping for a doctor who has been a pharma industry insider for years. Most of the funds he received from pharma companies were for travel or consulting under $5,000. Califf collected such funds from Merck, Johnson & Johnson, GlaxoSmithKline, AstraZeneca and Eli Lilly. His biggest consulting payment of $87,500 came from Johnson & Johnson in 2012.

Peter Pitts, the former FDA associate commissioner for external relations who served as senior communications and policy adviser to the commissioner, said that when Califf was at Duke, he was very much an explorer, ever on the hunt for new and better ways to conduct clinical trials.

“He is exactly the right man at the right time in the right place,” said Pitts, now president and co-founder of the Center for Medicine in the Public Interest, a nonprofit funded by PhRMA and Pfizer. “This is an opportunity for the FDA to step forward and have a real impact not just on applications that come from drug developers, but also to be in the center of the development of the healthcare ecosystem, where it can really help the public and private sectors unite to bring new types of science to bear on medicine.”

What of the Xarelto trial? A watchdog group called Project on Government Oversight (POGO) recently pointed to signifiant problems with trials for the drug Xarelto. The problem for Califf? He co-chaired the executive committee of the trial.

A senior FDA official wrote that a “lack of care” in the trial’s design and execution could have led to avoidable strokes among test subjects. Yet the FDA approved Xarelto in 2011 over the objections of the primary FDA scientists assigned to study its safety and effectiveness.

“Dr. Califf’s handling of the Xarelto trial raises concerns about his judgment in overseeing the pharmaceutical industry,” said POGO Executive Director Danielle Brian in November. “As senators consider Dr. Califf’s confirmation to run the FDA, they should ask tough questions about the Xarelto clinical trial.”

It’s now up to Republican senate majority leader Mitch McConnell to decide whether Califf’s nomination will be put to a vote before the full senate. This could happen at any time, or Califf’s nomination could stall out indefinitely.

But Califf’s contemporaries feel very confident that he can put aside his ties to the drug industry, and let his years in drug development inform him as he leads the agency fairly, with innovation and safety held top of mind. 

Eric Peterson, executive director of the Duke Clinical Research Institute, said, “Dr. Califf is built to serve the mission of the FDA—to protect the public’s health. He knows what is needed to pave the way for evidence-based medicine and disruptive technologies to flourish in the coming years and fulfill the promise of personalized medicine.” 

Suz Redfearn is an award-winning journalist and former senior staff writer for ClinPage.com. Her articles have appeared in numerous publications, including the Atlantic.com, the Washington Post, Slate, Salon, Politico, Men's Health, MedPage Today and Physicians Practice. Suz holds a degree in print journalism from Loyola University in New Orleans and has been a medical writer since 1990, focusing on clinical research since 2007. Email suzredfearn@gmail.com.

This article was reprinted from Volume 20, Issue 03, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »