Seems like smooth sailing for Califf’s FDA nomination

Dr. Robert Califf, President Obama’s nominee to be the Commissioner of the Food and Drug Administration (FDA), coasted through questions at a confirmation hearing Tuesday in front of the Senate Health, Education, Labor and Pensions (HELP) Committee. Although many thought the process may hit a few bumps due to his ties with the pharmaceutical industry, Republicans and Democrats alike seem to support his candidacy and the nomination seems expected.

Califf’s background

A cardiologist and clinical trial expert from Duke University, Dr. Califf has been a consultant to drug companies and ran a research institute that received a majority of its funding from the industry. Dr. Califf said in his prepared statement that we need “an unbiased FDA that can work with industry to advance critical technologies while still making independent determinations to ensure that scientific potential is translated into safe and effective products. To advance, we must find common ground with industry and academia on the science without compromising this fundamental role of the FDA.”

Califf’s ties to the industry raised concerns among some public health groups and some Democrats say that he is too close to the industry he is being called on to regulate. Many medical experts dispute that, saying that industry is a principal funder of research in the United States and that working with companies does not present an inherent conflict.

Although essentially friendly, the hearing was punctuated with a few skeptical questions from Senators Elizabeth Warren (D-Mass) and Bernie Sanders (I-VT), who is running for the Democratic presidential nomination. In response to questions from Warren, Califf told the committee that the clinical trials he conducted at Duke, if funded by a drug company, had “ironclad” contracts giving the investigators the final rights to publication. Sanders said aid that the FDA needs a candidate who can stand up to an industry that has been “ripping off” the American people by charging “outrageous” prices for medicines.

Vote

The HELP committee will vote on whether to approve Califf’s nomination, which must then be approved by the full Senate. Patient groups and medical associations are hoping that Califf will help to speed new drugs to market and have publicly supported Califf.