Scott Gottlieb: Conflicts surround Trump's FDA pick

Story highlights

  • Scott Gottlieb wants to change "FDA review culture" to fast-track drug approvals
  • Critics says his ties to big pharma go back decades and are too complex to avoid

(CNN)President Donald Trump's pick to lead the Food and Drug Administration, Scott Gottlieb, is a physician, a cancer survivor, a venture capitalist and a government insider who has long said he wants to tear down the wall of FDA regulations he believes is holding back innovation.

"In so heavily prioritizing one of its obligations -- the protection of consumers -- the FDA has sometimes subordinated and neglected its other key obligation, which is to guide new medical innovations to market," Gottlieb wrote in a 2012 issue of National Affairs. "Ultimately, the only way to change the threshold for approval of these sorts of drugs is to change the FDA review culture itself."
    The Pharmaceutical Research and Manufacturers of America, a trade and lobby association, sent out congratulations almost immediately after his nomination was announced in early March.
      "We look forward to working with Dr. Gottlieb in his new role," PhRMA President and CEO Stephen J. Ubl said, "as they seek to modernize the drug discovery and review process and advance competition in the biopharmaceutical market."
      But it's his decades-long financial ties to many of those pharmaceutical companies that have critics worried.
      "He currently is serving or has recently served on the boards of major pharmaceutical companies, including GlaxoSmithKline, one of the world's largest," said Dr. Michael Carome, director of Public Citizen, a consumer rights watchdog group. "And he has even more relationships that go back years."
        Carome points to Gottlieb's recent financial disclosure letter to the Health and Human Services associate general counsel for ethics as evidence. In that letter, Gottlieb disclosed financial relationships with over 25 entities, many of them giants in the biotech and pharmaceutical industries.
        "He's basically been a shill for pharmaceutical corporations for much of his career," Carome said, "and that has no doubt framed his thinking."
        "I'm not sure all of the sources of his income are measurable," said Harvard government professor Daniel Carpenter, author of "Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA." "That's something we hope the Senate will look at during his confirmation hearing."
        Gottlieb will not be available to the media for comment until after his confirmation. But a White House representative told CNN that, despite criticism, the administration believes Gottlieb to be highly qualified, seeing him as a strong leader that will advance Trump's agenda of reforming the drug industry.

        A Washington insider

        Gottlieb, 44, has a short history of public service. He was FDA deputy commissioner in the George W. Bush administration, did a yearlong stint as senior adviser to the administrator at the Centers for Medicare and Medicaid Services and currently serves on the federal Health IT Policy Committee.
        Despite his inside-the-Beltline exposure, Gottlieb's viewpoint on the FDA mirrors that of his potential boss: The agency needs an overhaul to reduce bureaucratic red tape and speed the drug pipeline.
        In a January meeting with pharma executives, Trump laid out a plan to deeply cut the FDA's regulatory playbook. "Instead of it being 9,000 pages, it'll be 100 pages," Trump told the group. "We're also going to be streamlining the process so that from your standpoint, so that when you have a drug, you can actually get it approved -- if it works -- instead of waiting for many, many years."
        The choice of Gottlieb appe