Califf Confirmed to Head FDA

The U.S. Senate voted overwhelmingly to approve Robert Califf, MD, to head FDA, despite concerns about his record on prescription painkillers and about labelling of genetically modified salmon.

Nancy Crotti

Senators voted 89 to 4 in favor of approving Califf, 64, a well-regarded Duke University cardiologist and researcher, after months of delays by Democratic presidential candidate Bernie Sanders and others. Sanders said he was concerned over what he described as Califf's close ties to the pharmaceutical industry.

After his confirmation, Califf told the Washington Post he would focus on bolstering FDA's staffing and "scientific infrastructure."

"My experience in the year I've been there is that we do really well at FDA when we have good evidence," the Post quoted Califf as saying. "And when we don't have good evidence, it's a matter of opinion and politics, and it often doesn't go as well because no one knows the right answer."

Califf, who has been FDA's deputy commissioner for medical products and tobacco since February 2015, faced scrutiny over how he helped manage a clinical trial at the heart of an investigation into the popular blood thinner Xarelto.

A medical device error may have distorted results in favor of Johnson & Johnson and Bayer, which developed the blood thinner. Xarelto has been targeted in lawsuits from more than 3000 plaintiffs in the United States, who allege that the drug is responsible for a host of adverse events, including abdominal bleeding and blood clots that can cause strokes or heart attacks.

Sen. Lisa Murkowski (R-AK) put a hold on the confirmation, saying she wanted assurances that FDA will require labeling of genetically modified salmon, which the agency approved last year. Seafood is a $5.8-billion-a-year industry for Alaska, according to the state's Department of Fish and Game.

Califf also faced tough questions during a November Senate committee confirmation hearing about how he would handle medical device and drug regulation as FDA chief. Califf said FDA should use the same system to track adverse events for both, citing the success of the agency's Sentinel Initiative for managing drug-related adverse events. Although he did not specifically mention the MAUDE database, the current method for tracking adverse events related to medical devices, Califf said that a Sentinel-like system might have done a better job of tracking duodenoscope-related infections.

Califf also told the Post that he would bolster FDA's staff to enable it to better respond to a quickly changing medical technology landscape, and "do a better job of explaining its decisions and policies on all fronts, including the public,"he said. "I think my record shows that I'm for medical products that work and are effective. When they're not, I've been outspoken."