Trump Taps Scott Gottlieb to Head FDA

Regulatory NewsRegulatory News
| 10 March 2017 | By Zachary Brennan 

Dr. Scott Gottlieb, a resident fellow at the American Enterprise Institute (AEI) and former US Food and Drug Administration (FDA) official, has been selected by President Donald Trump to lead FDA as commissioner. The White House confirmed the move on Friday and Gottlieb will face a Senate hearing and vote.

A clear front-runner for the position, FDA’s former deputy commissioner for medical and scientific affairs also was recently included in a Centers for Medicare & Medicaid database as having pulled in $199,951 in 2015 from industry, including more than $60,000 from GlaxoSmithKline, more than $50,000 from Daiichi Sankyo and more than $65,000 from Vertex Pharmaceuticals. Gottlieb told Focus last July that he sits on the GSK research and development board, serves on the board of directors for Daiichi and acts as a senior adviser to Vertex.

He’s also been a vocal critic of FDA. In May, he told Focus the agency needed to be more mindful of company expenses on updating generic labels: “FDA needs to bear more responsibility for updating the labels of old generic drugs and can take on that role, rather than foisting it onto generic drug makers in a way that will not only increase generic costs and expose them to the same sort of failure to warn suits that plague branded companies, but will undermine the generic model by creating incongruities between the labelling of the same generic drug, solely by virtue of the manufacturer and what CBE [changes-being-effected] supplements they happened to file. I think this is the most inefficient way to achieve what FDA purports to be their public health goal here, which is why I believe this was politically contrived, or at least politically influenced.”

In explaining his opposition to growing expenses for generic drug reviews, he seems clear on wanting to speed the process up.

“In 2003, when I began working at the FDA, we estimated that it cost less than $1 million for a firm to file a generic-drug application. A drug would have to fetch about $10 million in annual revenue before it would be subject to generic competition. Today, filing a generic application requires an average of about $5 million and can cost as much as $15 million,” he wrote in the Wall Street Journal. “This means that a drug may not face brisk generic competition until it exceeds $25 million in annual revenue. Thanks to these changes, infrequently used generics—such as clomipramine for major depression—may now have only one competitor and cost as much as branded drugs.”

And unlike some at FDA, he’s been a fan of review vouchers and also called to prioritize generic applications just as the agency began prioritizing them for sole-source products.

He wrote: “The FDA should prioritize applications for generic categories where competitors are exiting. Companies that pursue copies of ‘abandoned’ generics could receive a voucher that gives them expedited review of another generic drug. The value of this voucher would give firms more incentive to market copies of low-volume generics.

Gottlieb's also been an advocate of speeding the approval process through shorter trials.

“Longer, larger trials that require drug makers to evaluate “hard” endpoints (like how long a cancer patient lives) rather than "surrogate" endpoints (like a drug's ability to shrink tumors) give FDA reviewers more statistical confidence. Reviewers prefer these drawn-out trials because they insulate the FDA from critics who say that it isn't focused enough on safety. But bigger trials increase the time needed to develop a drug, keeping it out of the hands of patients,” he also wrote in the Wall Street Journal in 2010.


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