New FDA Nominee May Face Challenges for His Pharma Ties

A report in The New York Times identifies challenges that could be raised based on Califf's past associations with the drug industry.

Last week, President Obama announced the nomination of Robert Califf, MD, to take charge of the regulatory body from Stephen Ostroff, MD, who filled-in after Margaret Hamburg, MD, left early this year. However, a report in The New York Times points to challenges that could be raised based on Califf’s past associations with the drug industry.

Califf, currently the deputy commissioner for medical products and tobacco at the FDA, has had ties with the pharmaceutical industry, more so than any of the past leaders of the FDA. While Hamburg had a public health background prior to joining the FDA, Califf, a cardiologist by training, managed a multimillion-dollar clinical research center at Duke University with more than 60% industry funding.

According to The Times report, Califf has coauthored research papers with scientists from drug companies, he has consulted for drug companies and a device manufacturer, and his salary when at Duke was partially supported by industry funding. Interestingly, he has been on the advisory board of both Sanofi and Amgen, 2 companies currently competing for market share for their new, and very expensive, PCSK9 inhibitors.

To his credit, a department of Health and Human Services (HHS) spokesman told the paper that Califf had gone through “a comprehensive screening process for conflicts of interest,” and that measures to ensure his recuse from matters that would give rise to conflicts were in place. Additionally, there are reports of Califf donating all his consultation fees to nonprofits.

Colleagues and peers spoke to Califf’s integrity and expertise, which makes him suitable for the position for which he has been nominated. “His integrity in scientific matters is impeccable, and his innovation in clinical trial design is legendary,” said Steven Nissen, MD, a cardiologist at the Cleveland Clinic.

Referring to a slide presentation by Califf to biomedical researchers and industry experts where he identified regulation as a “barrier” to drug and device development, the HHS spokesman said that the slide was meant to “identify the challenge and the tension inherent in the FDA’s charge.”