Gottlieb Fares Better than Other Trump Picks: NYT
FDA commissioner Scott Gottlieb is getting mostly high marks from agency watchers, unlike many in Trump Administration top posts that have found themselves embroiled in controversy after controversy, according to a New York Times article. “Now, more than nine months after he was confirmed, Dr. Gottlieb has achieved something unusual among President Trump’s appointees: He has quieted some skeptics, while also managing to keep industry supporters content and the president on his side,” the article says. “He has done so by making moves to protect public health while also offering rewards to industry — double plays that have some willing to give him a second look.” Trump recently told an international audience in Davos, Switzerland that Gottlieb is a star.
Mark Schwartz, a Washington lawyer who previously worked at FDA in both Republican and Democratic administrations, told the Times reassuredly that Gottlieb isn’t looking to “blow up the agency.” While bringing in a few top officials from the outside, he has also made it a point to promote several agency veterans. “So far, the commissioner has displayed a collaborative management style, seeming to allay the concerns of some career employees who had balked at his industry ties and were dismayed by articles he had written criticizing the FDA,” the article notes. “He is described by staff as energetic and intense, while holding town hall-style meetings before making decisions.”
Former FDA associate commissioner for policy and planning William K. Hubbard told the Times that Gottlieb is “being thoughtful; he’s being deliberative... He seems to be putting aside some of his more extreme rhetoric from when he was outside, and working through the issues with a public-health orientation.”
Many important regulatory decisions impacting regulated industry are still undecided at FDA, and until these are advanced it is hard to grade Gottlieb’s performance on protecting and promoting public health. They include whether restrictions should be relaxed on disseminating off-label use information, the regulations of laboratory-developed tests, and reforms to speed up drug development, according to the Times. “That is where anxiety lies,” said Hubbard, who added that the key will be ensuring that, in moving new products to market more quickly, public health is not compromised. “The test will be whether he can do that safely, and we won’t know the results of that for quite some time.”
Before rejoining the agency last year, Gottlieb had advocated for relaxing certain off label promotion. “If the FDA surrenders on First Amendment issues, there could be very serious consequences for the agency’s ability to do its job,” former deputy commissioner Josh Sharfstein said. Meanwhile, Public Citizen health research director Michael Carome, who opposed Gottlieb’s nomination, said he has not seen anything to change his mind. “The bottom line is this: He’s pursuing a pro-industry deregulatory agenda that ultimately is going to put patients at risk,” Carome told the Times. “The FDA now views industry as their customers, and they need to keep them happy.”