Scrutinizing a drug regulator’s ties to industry
The Obama administration’s decision to name Dr. Robert Califf the next commissioner of the U.S. Food and Drug Administration remains steeped in controversy. He spent most of his career as a clinical researcher engaged in pharmaceutical industry-funded clinical trials.
Califf joined the FDA as deputy commissioner last March after 30 years as a medical researcher at Duke University School of Medicine. He was immediately charged with overseeing the agency’s office handling drugs, medical devices and tobacco products.
While at Duke, Califf gained the experience and expertise to head the FDA. He is credited with leading its efforts to improve research processes, and helped develop and lead the national Patient-Centered Outcomes Research Network, an initiative to enhance the quality of clinical evidence used in guiding health decisions.
But critics question Califf’s impartiality in regulating the pharmaceutical industry. As recently as 2014, his salary was supplemented by funding from several drug companies.
If confirmed this week by the Senate, Califf will oversee an agency under mounting pressure from drugmakers and lawmakers to streamline its review process. The 21st Century Cures Act has received bipartisan support, and passage by a Congress looking to avoid the “do nothing” label in this election year is a distinct possibility.
Consumer and safety advocates fear the law’s relaxation of FDA regulatory standards will come at the expense of product safety and efficacy. Califf’s interpretation of the law, should it pass, will be closely watched.
“In the history of the FDA, no other commissioner has had such a close financial relationship with big pharma as him,” said Dr. David Gortler, a former FDA senior medical officer who is now a drug safety and FDA policy expert. “There are dozens of other people who have research records equal to or superior to Dr. Califf’s without the overwhelming number of conflicts of interest.”
Pending position Commissioner designate
Organization U.S. Food and Drug Administration
Current position FDA deputy commissioner
Tenure in job
11 months Dr. Robert Califf