New FDA Head Moves Closer to Approval

FDA approval

Dr. Robert Califf, President Barack Obama’s nominee to head the Food and Drug Administration, moved closer to being confirmed after winning the backing from a Senate committee last week. Next stop, consideration from the full Senate. His consideration will bring a spotlight on how quickly the FDA should be moving to approve new drugs in its pipeline.

The Senate Committee on Health, Education, Labor and Pensions voted to confirm Califf as FDA Commissioner, a position left open since Dr. Margaret Hamburg left a year ago. Thus far most Senators have downplayed criticism from consumer watchdog groups that he is too closely linked with the pharmaceutical industry to lead the agency impartially.

Although Republican Senator Lisa Murkowski of Alaska voted in favor of moving the nomination to the full Senate, she repeated her threat to oppose the nomination if the FDA does not satisfy her demand for mandatory labeling of genetically engineered salmon.

Concerns Califf is too close to the Pharmaceutical Industry 

Democratic presidential candidate Bernie Sanders voted by proxy against the nomination, saying in a statement that the FDA needs a leader “who is prepared to stand up to the drug companies” and that Califf is not that person.

Califf is already working with the FDA, having started a year ago as a deputy commissioner. He is a prominent cardiologist who previously held senior positions at Duke University. However, as Sanders and others point out, while he was at Duke he founded a large academic research center that received more than half of its funding from the drug industry.

How fast should the FDA be moving?

Califf has also led multiple large-scale company-funded clinical trials and published more than 1,200 papers. His interest in streamlining the clinical trial process dovetails with those of patient groups and members of Congress who are eager to see new drugs brought to the market faster. Moving drug down the pipeline more quickly is important to Congress, the U.S. House of Representatives has passed a bill known as the 21st Century Cures Act that, among other things, would require the FDA to further loosen its clinical trial requirements. A similar bill is being considered in the Senate. No word on if the recent tragedy in France will affect this push.

Consumer watchdogs argue against the trend, saying the emphasis on speed risks sacrificing patient safety. Public Citizen says the Senate should reject Califf and nominate someone “better suited to protect public health.”

In 2015 the FDA seemed to be moving more quickly without the aid of new laws. The agency approved 45 new drugs, a huge increase when compared with an average of 28 a year over the last nine years. In a blog post earlier this month the agency said 60 percent of its drug applications were reviewed and approved on some sort of accelerated time-line and 64 percent of all new drugs were approved in the United States before any other country.

The FDA also regulates food, dietary supplements, tobacco and cosmetics, so drugs aren’t its only concern. Right now the agency is in the midst of implementing sweeping new food safety rules and is expected to issue a new rule this year giving it authority over the burgeoning e-cigarette industry.

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Lindsey McCoy MPA, is an Executive Medical Recruiter and former CEO in the not for profit sector.

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