- 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
"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 t
o 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