- President Obama's nominee for FDA Commissioner, Dr. Robert Califf, has close ties to the biopharma industry and has received more than $200,000 in consulting fees from major pharmaceutical companies. The fees collected were given to non-profits, according to a government spokesperson.
- President Barack Obama nominated Califf for the Commissioner position last week. Califf is currently functioning as the deputy commissioner until the nomination is finalized. In February, Dr. Margaret Hamburg stepped down as FDA Commissioner after presiding in that post since 2009.
- The consulting fees received by Califf included remuneration from Johnson & Johnson, Merck, GlaxoSmithKline (GSK), and a medical device company.
Califf comes with a great deal of biomedical and leadership experience, including his previous role as a cardiologist and clinical trial researcher at Duke University. During his tenure, he not only helped build the Duke Clinical Resarch Insitute, but he also was instrumental in conducting many clinical trials that were used to help the FDA make approval decisions. For example, he led a clinical trial of Xarelto (rivoroxaban) for J&J, receiving $48,560 in fees in exchange—all of which supposedly has been given to not-for-profits.
At this point, the government maintains that Califf has fully divested his financial interests in drug companies and has been fully vetted for potential conflicts of interest. In fact, FDA commissioners are not supposed to have any financial stake in drug companies, because of concerns that it could cloud their judgement. However, because of the Open Payments system, it is now possible to look historically and see how much a physician receives from various drug companies for various types of service.
While Dr. Califf has not spoken out about this issue pubicly, the general consensus among many is that he is operating above board. But that hasn't stopped some advocacy groups and industry critics such as Public Citizen from calling on the Senate to reject Califf's nomination.