Dr. Robert Califf is expected to become the next head of the U.S. Food and Drug Administration even though he's faced controversy since being nominated earlier this year.
Califf is scheduled to testify this week before the Senate Health, Education, Labor and Pensions (HELP) Committee, which likely will ask about his reported financial ties with the pharmaceutical industry, among other concerns voiced by critics.
Califf's nomination to replace Dr. Margaret Hamburg, who stepped down in March after six years in the role, was lauded by trade groups such as the Biotechnology Industry Organization and the Generic Pharmaceutical Association. They both cited Califf's expertise in clinical research as the basis for his qualifications.
But critics say Califf was paid by drugmakers while serving as director of the Duke Clinical Research Institute and that raises questions about his ability to remain impartial.
Opponents include Democratic presidential candidate Sen. Bernie Sanders of Vermont, who plans to vote no. “At a time when millions of Americans cannot afford to purchase the prescription drugs they need, we need a new leader at the FDA who is prepared to stand up to the pharmaceutical companies and work to substantially lower drug prices,” Sanders has said.
New England Journal of Medicine Editor-in-Chief Dr. Jeffrey Drazen came to Califf's defense last month in an editorial endorsing his nomination. Still, these controversies are unlikely to block his confirmation, as a number of conservative members of the Senate HELP Committee—including the chairman, Sen. Lamar Alexander—have voiced their support.
