publication date: Sep. 18, 2015

Robert Califf Tapped for FDA Commissioner Position

By Paul Goldberg

President Barack Obama nominated Robert Califf to the post of Commissioner of Food and Drugs.

Earlier this year, Califf was named FDA Deputy Commissioner for Medical Products and Tobacco, a de facto No. 2 post at the agency. Califf, 63, is an expert in cardiology, clinical research, and medical economics.

Califf, 63, spent the preceding 33 years at Duke University, most recently as vice chancellor of clinical and translational research.

At FDA, he oversaw the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Tobacco Products. He will also oversee the Office of Special Medical Programs in the Office of the Commissioner.

Califf has said that he has been interviewed for the job of FDA commissioner twice before, during the Bush and Obama administrations.

Califf has served as director of the Duke Translational Medicine Institute and professor of medicine in the Division of Cardiology. Prior to that, he was the founding director of the Duke Clinical Research Institute, which is described as the world’s largest academic research organization.

Califf is recognized by the Institute for Scientific Information as one of the top 10 most cited medical authors, with more than 1,200 peer-reviewed publications.

He was a member of the Institute of Medicine committees that recommended Medicare coverage of clinical trials and the removal of ephedra from the market, and of the IOM’s Committee on Identifying and Preventing Medication Errors.

In addition, he served as a member of the FDA Cardiorenal Advisory Panel and FDA Science Board’s Subcommittee on Science and Technology. Currently, he is a member of the IOM Policy Committee and liaison to the Forum in Drug Discovery, Development, and Translation.

Califf had no oversight authority over clinical trials of genomic predictors that were constructed by Duke scientists Joseph Nevins and Anil Potti. The predictors have since been discredited as fraudulent and publications describing them have been retracted.

High-level academic administrators at Duke were involved in keeping the research and clinical trials going, silencing a whistleblower and ignoring doubts expressed by lab insiders. Califf’s name doesn’t figure in any of the internal Duke e-mails obtained by The Cancer Letter.

Califf stepped into the scandal at a later date, helping investigate it and acting as a point person in interactions with a panel of the Institute of Medicine and speaking for Duke to the CBS news program 60 Minutes.

“We believe that with Dr. Califf’s diverse background, and his exemplary knowledge of clinical and translational medicine, he will continue to improve the FDA’s drug approval process while ensuring that patients are receiving the safest and most effective treatments as quickly as possible,” Friends of Cancer Research, a Washington group, said in a statement. “Friends looks forward to working with Dr. Califf on vital issues that directly impact patients’ lives and to being a resource to help drive FDA’s commitment to personalized medicine, and enhance the agencies engagement with stakeholders and patients.”

Biotechnology Industry Organization President and CEO Jim Greenwood commended the President for nominating Califf and urged the Senate to consider his confirmation as soon as possible.

“Dr. Califf is a respected cardiologist and clinical trial expert with a firm understanding of the challenges and opportunities of 21st century medicine,” Greenwood said. “The FDA deserves a strong, confirmed Commissioner to effectively fulfill its expanding obligations and maintain appropriate standards for the safety and effectiveness of advanced therapies.”

Michael Carome, Director, Public Citizen’s Health Research Group, urged the Senate to reject Califf.

“His nomination undoubtedly comes as welcome news to the pharmaceutical and medical device manufacturers, but is bad news for patients and public health,” Carome said. “During his tenure at Duke University, Califf racked up a long history of extensive financial ties to multiple drug and medical device companies, including Amgen, AstraZeneca, Eli Lilly, Johnson & Johnson, Merck Sharp & Dohme and Sanofi-Aventis, to name a few. Strikingly, no FDA commissioner has had such close financial relationships with industries regulated by the agency prior to being appointed.

“Califf’s appointment as FDA commissioner would accelerate a decades-long trend in which agency leadership too often makes decisions that are aligned more with the interests of industry, rather than those of public health and patients.”

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