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Why Califf Still Faces Hurdles to Become FDA Commissioner

U.S. senators concerned over genetically modified salmon and too much industry coziness could hold up a full Senate floor vote for Robert Califf, MD. More medical device regulation issues could crop up, too.

Chris Newmarker

Updated January 13, 2016

Robert Califf
Robert Califf

FDA commissioner nominee Robert Califf, MD, received an important U.S. Senate committee approval this week. But the Duke University cardiologist still faces important hurdles.

Sen. Lisa Murkowski, R-AK, told fellow Senate Health, Education, Labor and Pensions Committee members on Tuesday that she planned to place a "hold" on a full Senate floor 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.

"Sometimes I feel like my issues are very parochial. But you know what, that's what we do around here. ... When it comes to the FDA, the one thing that is very important is what is going on with fish," Murkowski said.

"If there are issues, I hope those conversations can be speedy because of the size of the responsibility he has at FDA. We need an impressive leader in a confirmed position there," Sen. Lamar Alexander, R-TN, the committee's chairman, said while wrapping up the Tuesday meeting.

Another potential vote hold could come from Sen. Bernie Sanders, D-VT. Sanders, who is vying for the Democratic presidential nomination, said Tuesday FDA needs a leader who is prepared to stand up to the drug companies.

"Dr. Califf is not that person. His extensive ties to the pharmaceutical industry give me no reason to believe that he would make the FDA work for ordinary Americans, rather than pharmaceutical industry CEOs who are more focused on making obscene profits than saving lives," Sanders said in a statement posted on his website.

Besides the potential vote holds from Murkowski and Sanders, there is a chance that Califf may end up facing more questions about FDA's medical device approval process. For example, a letter obtained by NBC News shows the Senate Judiciary Committee, chaired by Sen. Charles Grassley, R-IA, seeking information about how FDA handled potentially deadly problems with CR Bard blood filter products.

Califf, who has been FDA's deputy commissioner for medical products and tobacco since February 2015, has himself 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.

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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