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Gottlieb faces Senate committee as critics highlight industry ties (Regulatory)

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CREDIT: This post was originally published on this site

The day before Scott Gottlieb faced a Senate committee on Wednesday, the FDA commissioner nominee hit pushback from Democrats who say he’s too entangled in the pharma industry to be an independent regulator. And that line of questioning continued on Wednesday as his confirmation got underway on Capitol Hill.

At the same time, the pharma industry continues to hail President Donald Trump’s FDA pick as a pragmatic leader who understands both drug development and regulation—and much less dangerous to biopharma than the more unconventional candidates Trump had floated. On Wednesday, some members of Senate hailed his experience, with Sen. Richard Burr, R-N.C., saying the “criticisms are about his successes.”

RELATED: Trump pick Gottlieb likely to speed FDA nods without tossing agency’s risk-benefit model

Gottlieb appeared at the Senate’s Health, Education, Labor and Pensions committee on Wednesday, where he faced questions not only about his plans for the agency, but also about a web of financial and professional ties to the industry. Disclosures Gottlieb filed in advance of the hearing include pages full of investments, board seats, consulting jobs and other financial relationships.

Trump has repeatedly said he wants to chop regulations and speed drugs to approval, which likely played a role in his picking Gottlieb. The former deputy FDA commissioner is on record with suggestions for streamlining drug approvals—and opposition to some of pharma’s least favorite proposals, such as drug importation, now under consideration in Congress.

At the confirmation hearing, frequent pharma critic Sen. Bernie Sanders, I-Vt., pointed out that Trump campaigned on a pledge to “drain the swamp” but again nominated someone with strong industry ties. Sen. Patty Murray, D-Wash., also used much of her time to lambaste Gottlieb’s interests in the industry.

On the other side of the aisle, Sen. Lamar Alexandar, R-Tenn., told the committee he views Gottlieb’s industry dealings as a strength, pointing out that former FDA commissioner Robert Califf had similar job credentials. Sen. Tim Scott, R-S.C., said that Gottlieb would bring a “healthy balance” of experience to the job, adding that the nominee has support from Califf and another former FDA commissioner, Margaret Hamburg.

Still, Califf’s $60,000 income from pharmaceutical companies between 2013 and 2015 was far below Gottlieb’s 1-year income of about $3 million, CNN pointed out. Harvard government professor Daniel Carpenter told the news outlet Califf’s pharma ties were “due to his innovative clinical trial expertise” as opposed to Gottlieb’s “political connections at the FDA.”

Trump chose Gottlieb over other possibilities, acknowledged and rumored, who held much more radical views of the FDA. Venture capitalist Jim O’Neill, for instance, had said that the agency should scrap late-stage clinical trials to speed new treatments to market, a view unpopular with pharma companies that rely on the FDA’s imprimatur as a seal of quality.

The day before the hearing, Sens. Edward Markey, D-Mass., and Sherrod Brown, D-Ohio, argued that Gottlieb is too close with pharma to properly address the country’s opioid crisis. Markey said Gottlieb “will not do the job,” according to Forbes.

A cancer survivor, Gottlieb currently serves as a partner at venture giant New Enterprise Associates and as a resident fellow at the conservative think tank American Enterprise Institute. He’s a current member of GlaxoSmithKline’s R&D portfolio investment board and a board member at multiple other life sciences companies. He was a deputy FDA commissioner during the George W. Bush administration and has contributed to Forbes, among various other roles.

Aside from his role with GSK, Gottlieb is an independent board member for Daiichi Sankyo U.S. and Tolero Pharmaceuticals. He’s worked as a consultant for Vertex Pharmaceuticals and Bristol-Myers Squibb.

Public Citizen’s medical research group director Michael Carome is with those who are worried about the nominee, saying Gottlieb “spent most of his career dedicated to promoting the financial interests of the pharmaceutical industry.” Carome said in a statement the Senate “must reject” Gottlieb.

RELATED: Trump’s FDA choice Gottlieb offers solution to conflict-of-interest claims

Last week, Gottlieb wrote to the ethics head of the Department of Health and Human Services to say he’d recuse himself on decisions where there would be a financial conflict of interest. He’s also agreed to step down from a number of his positions upon confirmation and divest other financial interests. Critics say recusal isn’t enough because of the FDA commissioner’s broad industry influence.

Despite the critics, Gottlieb isn’t without strong backing from those who see his experience as credentials that show he can understand both government and industry. A Mizuho Securities poll before the nomination found that 72% of 53 execs supported Gottlieb for the job.

One anonymous exec polled wrote that Gottlieb is “eminently qualified to lead the FDA and to remove some of the regulatory roadblocks while ensuring that the health and safety of the public are preserved.”

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