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Bernie Sanders Delays Califf's FDA Nomination

Bernie Sanders is the latest U.S. senator to place a "hold" on a vote to confirm Robert Califf as FDA commissioner.

Qmed Staff

Bernie Sanders

Add Democratic presidential contender Bernie Sanders to the list of U.S. senators seeking to delay Robert Califf, MD, from becoming FDA commissioner.

Sanders, D-VT, said Tuesday that he was joining Sen. Edward Markey, D-MA, to place a "hold" on a Senate floor vote. Sanders said he was concerned over what he described as Califf's close ties to the pharmaceutical industry.

"I share Sen. Markey's concerns that the FDA must change the way it approaches addiction. Too many Americans are dying from what has become an opioid epidemic," Sanders said in a news release. "I also strongly believe that at a time when millions of Americans cannot afford to purchase the prescription drugs they require, we need a leader at the FDA who is prepared to stand up to the drug companies."

"We need someone who will work to substantially lower drug prices, implement rules to safely import brand-name drugs from Canada and hold companies accountable who defraud our government," Sanders said.

Sen. Lisa Murkowski, R-AK, previously said that she, too, would place a hold on the vote. Murkowski wants 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 Murkowski's state, and Alaska has one of the largest salmon fisheries in the world, according to the Alaska Department of Fish and Game.

Califf, who has been FDA's deputy commissioner for medical products and tobacco since February 2015, has also 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. During his confirmation hearing, Califf stressed the importance of post-market surveillance for drugs and devices.

"It is encouraging to see senators' reluctance to speed a nominee through the revolving door to head one of our biggest federal agencies. This third hold on Dr. Robert Califf's nomination sends a clear message that the Senate is concerned about Califf," Danielle Brian, executive director of the Project on Government Oversight, told STAT.

Image from www.sanders.senate.gov/

Learn more about cutting-edge medical devices at MD&M West, February 9-11 at the Anaheim Convention Center in Anaheim, CA.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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