fda

Califf clears key hurdle to FDA top job

pharmafile | February 23, 2016 | News story | Manufacturing and Production, Medical Communications, Research and Development  

Dr Robert Califf, President Obama’s nominee to head up the US Food and Drugs Administration as commissioner, has edged a step closer to being confirmed in the role, as the Senate voted overwhelmingly Monday to advance the matter to a final vote.

Legislation dictated that yesterday’s vote was required, to prevent opponents to Califf blocking his confirmation indefinitely. Senators voted 80-6 in favour of limiting further debate on his appointment to no longer than 30 hours, meaning the FDA could finally have its new leader confirmed as early as today in a final, binding vote.

Democrat senators Edward Markey and Joe Manchin were among those attempting to block the confirmation vote; both having concerns with the FDA’s approach to the approval process for opioid painkillers.

In the US, addiction to such products is seen as a growing epidemic, and the Agency was forced to overhaul its policy earlier this month: agreeing amongst other measures to toughen warning labels.  

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Presidential candidate Bernie Sanders joined Markey and Manchin in opposing Califf, due to what they consider a weak response on the opioid issue, as well as the candidate’s historic links to the pharmaceutical industry from his time as a researcher at the Duke University.

Manchin said yesterday that the FDA “must break its cosy relationship with the pharmaceutical industry”, and noted that more people die of legal prescription drug abuse in West Virginia than any other cause.  

Despite such opposition, Dr Califf, who has served as deputy commissioner at the FDA for a year, is now almost certain to take the top job this week after the 30 hours of debate are over, following what are sure to be forceful arguments from the opposing senators.  

Joel Levy

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