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Obama FDA commissioner nominee Califf defends big pharma ties

Published on 18/11/15 at 03:12pm
US Capitol building
Some members of the US Senate have questioned the nomination of Dr Robert Califf as FDA Commissioner

President Obama’s nominee to head the FDA was forced to defend his history of ties to the pharma industry as he was questioned by US senators at his confirmation hearing for the position.

Although it appeared the majority of senators at Dr Robert Califf’s two-hour confirmation hearing supported his nomination, certain senators raised doubts, and revealed they would not be voting for the 64-year old to take the top job.

Democratic candidates pressed Califf hardest, with some calling into question his commitment to lowering drug prices to ensure patient access and decreasing drug approval times, as well as payments he has received from pharma companies in the past.

Califf, a cardiologist who currently holds the number two position at the FDA of deputy commissioner, spent 30 years at the Duke University, where he founded a $200 million research institute funded mainly by pharma and received consulting fees which reached $29,000 in 2014.

The university oversaw many major clinical trials during Califf’s tenure, including for Johnson & Johnson's Xarelto (rivaroxaban), for which he received some $50,000. 

The Obama administration has stated that Califf donated his consulting fees to non-profit organisations, and that he had also divested any stakes he previously held in pharma companies.

Democratic presidential nominee candidate Bernie Sanders, who has vowed to crack down on the pharma industry and made drug pricing a central part of his campaign, stated his intention to oppose Califf’s nomination, saying his ‘isn’t strong enough’ on the issue.

"I believe we need a commissioner who is going to stand up to the pharmaceutical industry and protect American consumers," Sanders commented. "You are not that person…I respect the work you have done, but at the end of the day, people are dying. We have been extraordinarily weak in taking on the pharmaceutical companies.”

During the hearing, Califf defended his record and denied his past amounted to a conflict of interest, saying: “Yes, the industry funds studies. But we have an independent voice guaranteed by a contract… I think the American public completely depends on having confidence that the FDA is independent.”

Califf, who joined the FDA in February, also noted that his work was open to scrutiny, as it had all been published. When asked by Senator Elizabeth Warren about the ‘significant compensation’ he had received from pharma companies, and the influence they may have resultantly had over his research and drug approval times, Califf argued that his record spoke for itself and that he had “never been a proponent of lowering standards.”

He also claimed that he had declined to conduct 70% of studies because the drug companies involved would not meet his criteria for trial data transparency.

While Warren did not say she would reject Califf's nomination as FDA chief, she added she would not vote until reviewing all his contracts from his Duke years.

Despite focused criticism, some senators had no qualms about offering their support to the candidate, with much of the positive remarks coming from the Republican aide of the house.

In his opening remarks to the hearing, Tennessee Senator Lamar Alexander, who had previously expressed doubts over Califf’s suitability, said: “My staff has spent two months carefully reviewing everything you submitted and has not found anything that would call into doubt your ability to lead the FDA fairly and impartially.

Republican Utah Senator, Orrin Hatch, added: “I’m very impressed with what you do...You’d add a great deal to the FDA.” Hatch also argued in favour of longer drug patents.

Califf’s nomination is expected to be successful at the confirmation vote, which is yet to be scheduled.

Joel Levy

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