From the pages of the Washington Examiner …
Industry ties could be at issue for possible FDA pick
Respected cardiologist Dr. Robert Califf appears to be a top candidate to be the next head of the Food and Drug Administration but may face heated Senate queries over close ties to pharmaceutical companies if nominated for the post.
The Duke University cardiologist and researcher was appointed as the agency's deputy commissioner for medical products and tobacco by the FDA last month and will start in March.
At the time, several FDA and industry insiders believed the appointment signaled that Califf would be FDA Commissioner Dr. Margaret “Peggy” Hamburg's eventual successor.
Now that Hamburg officially resigned last week, insiders continue to believe Califf will be selected by President Obama to fill the position.
“I have a short list of one person, and that is Robert Califf,” Peter Pitts, president of the think tank Center for Medicine in the Public Interest, told the Washington Examiner.
Pitts, a former FDA associate commissioner, said Califf would have bipartisan appeal. He was interviewed for the top job during the Bush administration and the Obama administration.
Califf currently serves as vice chancellor of clinical and translational research at Duke University, and was founding director of the Duke Clinical Research Institute, which conducts clinical trials for several drugmakers. He will take a leave of absence from the university to fill the deputy director position.
Califf is a logical choice because he is an accomplished researcher who has more than 1,000 manuscripts to his name, which is a rare feat, Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, told the Examiner.
Nissen and Califf clashed at times while serving on FDA advisory committees, but Nissen said his colleague has a high degree of scientific integrity.
Califf was part of the Institute of Medicine committees that recommended Medicare coverage of clinical trials and the removal of the unsafe weight-loss supplement ephedra from the market, the FDA said.
While Califf has extensive research credentials, he also has extensive ties to the pharmaceutical industry.
He has received research grants from pharmaceutical giants Novartis, Johnson & Johnson, Lilly, Merck and Schering-Plough. He also consulted for Boehringer Ingelheim, Bayer, Bristol Myers Squibb, device giant Medtronic and other companies, according to a disclosure statement on the Duke institute website.
Califf was named to the board of directors for San Francisco drug manufacturer Portola Pharmaceuticals in 2012 but resigned soon after being appointed to the FDA post.
Nissen conceded that the ties could be a liability and may come up during a confirmation hearing.
The issue is “what if he is in the position to make decisions about companies with whom he has working relationships,” Nissen said. “I think his integrity makes that less of an issue, but that is in the eye of the beholder.”
Public advocates and some members of Congress have previously criticized the FDA for being too close to industry. The advocacy group Public Citizen noted recently that during Hamburg’s tenure the FDA grew even “more cozy with the industries that it regulates.”
Another potential focal point during confirmation could be Califf’s handling of a data fabrication scandal while at Duke. Califf was vice chancellor of Duke’s clinical research division when Dr. Anil Potti was caught in 2012 fabricating cancer research. Califf told CBS News that year he is responsible for retracting Potti’s various papers in medical journals and implementing new oversight procedures at Duke.
To be confirmed, Califf must first be vetted by the Senate Committee on Health, Education, Labor and Pensions.
The White House hasn’t announced a timeline for selecting a replacement. Press secretary Josh Earnest said during a briefing Friday the president will want someone with “impeccable medical and scientific credentials” that can also muster strong bipartisan support.
Califf did not return a request for comment as of press time. During a recent conference call with reporters on the deputy director appointment, Califf said that such a promotion “has not been a part of the discussion,” according to the Wall Street Journal.