Senators Hint at Confirmation of Califf as Next FDA Commissioner

Posted 17 November 2015 By Zachary Brennan

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Senators on both sides of the aisle offered their support for Robert Califf to be the next commissioner of the US Food and Drug Administration (FDA) at the confirmation hearing Tuesday despite a couple of heated questions on drug pricing and industry’s influence on him.

Califf did his best to quell any concerns over industry influencing his decisions as head of the agency and the majority of senators at the hearing seemed confident that his experience makes him the right candidate to succeed Margaret Hamburg.

Chairman of the Senate Committee on Health, Education, Labor and Pensions (HELP), Sen. Lamar Alexander (R-TN), set the tone of the hearing at the outset, noting that Califf has been put through an exhaustive vetting process and that neither Alexander nor his staff have encountered any issues that might prevent Califf from becoming commissioner.

Similarly, Sen. Patty Murray (D-WA) called Califf a “strong candidate” for the position and said she would encourage her colleagues to vote for him.

The issue of rising drug prices, which has been an increasingly hot topic for Congress, cropped up several times and Califf stressed that pricing does not fall under the purview of the agency though there are several tactics FDA could employ to address the issue, including work around cleaning up and expediting the clinical trials process.

Questioning

The most heated questions of the hearing came from Democratic presidential candidate Sen. Bernie Sanders (D-VT), who even before the hearing said he would oppose Califf. Sanders specifically questioned the former director of the Duke Clinical Research Institute over how FDA is able to import seafood from all over the world but not brand name drugs from Canada.

“We can bring in vegetables and fish from all over the world, but not brand name drugs from a country like Canada?” Sanders said. “I can’t accept that … We need a commissioner who’s going to stand up to the industry – you are not that person.”

Califf stressed that FDA has the capability to allow drug imports from countries like Canada, but he noted the cost and burden on the under-funded FDA to create such a system.

Sen. Elizabeth Warren (D-MA) also raised questions about whether Califf might lower the standards for FDA's approval of drugs, though Califf maintained that he would not.

“I’ve never been a proponent of lowering standards for anything,” Califf said. Warren added that she will not vote on his nomination until she reads all of Duke's contracts with industry while he oversaw the research.  

A handful of other senators raised questions about FDA’s use of non-binding guidance, rather than rulemaking, which is legally binding, to regulate the industries it oversees. But Califf didn’t hint at any policy changes and said the guidance documents are important for industry.

As far as what he would focus on, Califf mentioned several times the need for a better system to monitor medical devices once they’re on the market, the possible need for a new pathway to regulate drug/device combination products and new ways to ensure all clinical research gets published.

On the nagging issue of the generic drug backlog at FDA, Alexander asked how FDA can reduce it and Califf noted that the agency is well ahead of its Generic Drug User Fee Act goals “but we can do better.” He also explained that manufacturing issues and incomplete applications are a few of the reasons why more abbreviated new drug applications are not being approved more quickly.

In addition, Califf said the agency is still in the process of working through industry and other comments on a generic drug labeling rule mentioned by several senators.

As far as when to expect a yea or nay vote on Califf, the Senate HELP committee has yet to offer a definitive date though none of the senators at the hearing indicated that they would stall a vote.

 

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Categories: Biologics and biotechnology, Blood, Combination products, Drugs, In vitro diagnostics, Medical Devices, Clinical, Government affairs, Manufacturing, Postmarket surveillance, Preclinical, Research and development, Quality, Regulatory strategy, Regulatory intelligence, News, US, FDA

Tags: Califf, Senate HELP, FDA commissioner, Senate confirmation hearing, Duke University, Margaret Hamburg, Elizabeth Warren, Bernie Sanders

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