Scott Gottlieb – April 5, 2017 Zach Gibson/Getty Images
Senate Democrats didn’t waste any time in raising their objections to Scott Gottlieb as the next FDA commissioner.
Senator Patty Murray (D-Washington) started her remarks at Gottlieb’s confirmation hearing this morning voicing her concerns about “whether you can withstand political pressure” in maintaining an unbiased, science-based approach in maintaining the gold standard on safety and efficacy reviews of new drugs.
Murray complained that senators had only days to review Gottlieb’s “unprecedented financial entanglements” in the pharma industry — with dozens of drugs from the companies he’s worked with headed to the FDA — as well as more than 800 listed publications which “raise concerns about potential conflicts of interest.”
Gottlieb, though, came prepared to rebut those suggestions, making promises to maintain an independent FDA committed to finding new efficiencies at the agency while making sure that all the new products the agency approves are safe and effective, meeting the agency’s long-term gold standard on R&D.
“I’ve seen the importance of the FDA’s work as both a doctor and a patient,” Gottlieb, a cancer survivor, said in his opening statement. He added that his investments and endeavors were aimed at improving healthcare in the US. Some have worked, others didn’t and many others are still in development.
Regardless of those ties, he vowed to be an “impartial and independent advocate for the public health” maintaining a rigorous approach to reviewing drugs. “We’re at an inflection point in biomedical science,” he added, and the challenge at the FDA will be getting the most bang for its regulatory bucks.
“We should reject the false dichotomy that it all boils down to a choice between speed and safety.” Better efficiency and safety are both possible, he said, while maintaining the gold standard. And he added that “it’s incumbent on us to have a world class work force,” hiring the best for regulatory work, which Senator Lamar Alexander noted was Gottlieb’s pick as his most important challenge.
Gottlieb also helped soothe any industry concerns that he might want to come in as an abrasive reformer, working at odds with staff.
“I think everything is a bottom-up approach in the agency,” he told the lawmakers. “The ideas really need to come from the career staff in the centers.” That’s going to be a challenge as the agency recruits replacements for a lineup of senior agency officials who are due for retirement.
Gottlieb promised to bring best practices to those areas in the FDA that have been lagging. There’s been an “uneven adoption” of the breakthrough drug program, he added, which now requires broad adoption. The prospective commissioner also said that while he was not critical of Phase III, there is a possibility with new technology to compress Phase II and Phase III into an adaptive design.
And, as expected, he relished the prospect of tackling a slew of complex generics awaiting an approval at the FDA. Many drugs are sold at high prices, he said, but should be subject to competition.
A few days ago Gottlieb carefully delineated ties to some two dozen biopharma companies he’s been working with over the past eight years of the Obama administration. He’s worked with GlaxoSmithKline, Vertex and Bristol-Myers, so you can check the box on industry conflicts of interest that Democrats will condemn.
Among Gottlieb’s other lines of work, the former deputy FDA commissioner penned a series of articles on biopharma for Forbes, and the Dems have been giving them a close look. Two pieces floated to the top of the reading list. One centered on his proposal to move responsibility for identifying the opioid suppliers who were breaking the law from the DEA to HHS. The other dealt with his criticism of the REMS programs, which set up post-marketing safety programs to limit risks seen in certain drugs.
Add it all up, says Sherrod Brown (D-Ohio), and you find someone who will “roll over for his Big Pharma friends,” as The Hill reports.
Republicans, though, were largely content to limit their comments to praise for the nominee and his three young daughters, who were seated behind the candidate. And it’s the Republicans who have the votes to make this happen.
The industry, meanwhile, has made it clear that after hearing some of the ideas backed by other commissioner candidates like Jim O’Neill – who’s suggested approving drugs as soon as they’re determined safe — Gottlieb is the best candidate by far. In a snap poll of qualified Endpoints News subscribers, 87% of the 580 who registered an opinion backed Gottlieb’s nomination.
So you can expect most people in biopharma to keep their fingers crossed for Gottlieb.
Bottom line: Gottlieb came well prepared for every question, careful not to step beyond the boundaries of the commissioner’s job when invited to comment on Obamacare. His answers were polished and practiced, leaving little room for unexpected attacks. And he deflected criticism easily, promising to avoid any potential conflicts of interest.
Barring a last minute surprise, Gottlieb’s confirmation as the next FDA commissioner is all but guaranteed.
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