Warren and Sanders grill Obama nominee for FDA chief

Traci Badalucco | Medill News Service

WASHINGTON – President Obama’s pick to head the Food and Drug Administration came under scrutiny Tuesday, but it wasn’t the Republicans who were complaining. Democrats sharply questioned Dr. Robert Califf on the affordability of costly pharmaceuticals and the hefty funding drug companies provided for clinical trials he oversaw at Duke University.

Sen. Bernie Sanders, D-Vt., taking time away from his presidential campaign, criticized what he called Califf’s inability to stand up to pharmaceutical companies who are “ripping off the American people.”

Americans pay the highest prices for drugs in the world, said Sanders, who advocated for re-importing drugs from Canada where he said they go for a fraction of the cost in the United States.

After listening to Califf’s testimony before the Health, Education, Labor & Pensions Committee, Sanders told him: “You still don’t get that. You are not strong enough on this issue” of affordability. Sanders said Medicare, the huge government insurer of older Americans, should have the right to negotiate drug prices for its customers.

Califf, 64, a cardiologist from Anderson, South Carolina and current FDA deputy commissioner for medical products and tobacco, a position he’s held since January, was nominated by the president to lead the FDA in September.

A researcher at Duke University Medical Center prior to taking his current position, Califf led clinical trials at the university, leading to concerns from some lawmakers who cited his ties to pharmaceutical companies and questioned the sources of funding for his studies.

Sen. Elizabeth Warren, D-Mass., said “significant financial support” from pharmaceutical companies for Carliff’s research was “no secret.” She said it raised questions about the nature of his relationships with drug companies.

Cadiff argued that all the clinical trial studies he oversaw have been published, adding that, “In no case did we allow the company to provide analysis.”

In many cases, he said he was unable to pursue a promising trial because potential financial supporters were unwilling to meet the standards set by the university.

Cadiff was firm in his stand against moving lower cost generic drugs to the marketplace too quickly. He said safety must come first, no matter how long the process takes.

Generic drugs are similar to original products, he conceded, but “you’ve got to treat each one differently.”

The FDA is charged with overseeing pharmaceutical drug approval in the U.S., as well as food labeling.

Califf drew mostly positive comments from the senators, suggesting his nomination will likely be approved in committee and cleared for a vote by the full Senate. “He is a great man,” said Sen. Richard Burr, R-N.C. “And I think that stands out most in his qualifications.”