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Monday, December 09, 2019

Senate Panel Approves Obama’s Pick For FDA Commissioner

By Vera Bergengruen, McClatchy Washington Bureau (TNS)

WASHINGTON — A Senate panel on Tuesday cleared President Barack Obama’s nominee to head the Food and Drug Administration, cardiologist Dr. Robert Califf.

While he was approved on a voice vote by the Senate Committee on Health, Education, Labor and Pensions, Califf’s close relationship to the pharmaceutical industry still raised concerns.

“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 CEOs who are more focused on making obscene profits than saving lives,” Vermont independent Sen. Bernie Sanders, who sits on the Senate health committee, said in a statement Tuesday.

Sanders, who is a candidate for the Democratic presidential nomination, did not attend Tuesday’s vote but voted no by proxy and said he is considering holding up Califf’s nomination.

Alaska Republican Sen. Lisa Murkowski also said she will block Califf’s path to a full Senate vote over a clash about labeling genetically modified salmon. She said she was angry that the FDA issued guidelines calling for voluntary, not mandatory, labeling of genetically modified foods after Califf promised to listen to her concerns.

Despite this opposition, Califf’s nomination has strong bipartisan support, and the voice vote Tuesday indicates that while other White House nominations still may be held up, FDA leadership is a priority. The position has been open since Dr. Margaret Hamburg stepped down last February.

Tuesday’s committee vote “reflects the importance of having a strong leader at the FDA and shows that Dr. Califf is uniquely qualified to fill that role,” said Dr. Ellen Sigal, chairwoman of Friends of Cancer Research nonprofit group.

“While we had hoped this could have been done before the new year, the vote today should push the full Senate to confirm Dr. Califf immediately,” she said.

Califf was serving as deputy commissioner, the agency’s No. 2 spot, when Obama nominated him to lead the FDA in September. A prolific researcher, the Columbia, S.C., native previously spent three decades at Duke University, where he founded Duke’s Clinical Research Institute.

His institute receives $320 million in annual funding, and more than 63 percent of its projects are funded by pharmaceutical and medical companies, according to its annual report. This, in addition to his role as a consultant to several drug companies, raised some skepticism at his confirmation hearing.

According to federal government open payments data, in 2014 Califf personally received more than $29,000 in consulting fees, meals and travel expenses. Several lawmakers and advocacy groups have questioned his close ties to the pharmaceutical industry, which could prove to be a conflict of interest when regulating former clients.

Califf will inherit an agency that faces a slate of challenges in the last year of the Obama administration. The FDA is under increasing pressure to speed up the drug approval process and to extend its regulation of tobacco to include electronic cigarettes. The agency also is in the middle of overhauling how it controls food safety practices for companies in order to prevent foodborne illnesses and to end delays on labeling cheaper copies of biologic drugs, known as biosimilars.

Califf’s nomination for FDA commissioner will now go before a full Senate vote.

©2016 McClatchy Washington Bureau. Distributed by Tribune Content Agency, LLC.

Photo: Food and Drug Administration Commissioner nominee Doctor Robert Califf testifies at his nomination hearing at the Senate Health, Education, Labor and Pensions Committee on Capitol Hill in Washington, November 17, 2015. REUTERS/Gary Cameron  

 

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