US FDA Commissioner Gottlieb Sees His Job As A Race Against The Clock
Executive Summary
'You have much less time in these jobs than you think you’re going to have,' Gottlieb says.
US FDA Commissioner Scott Gottlieb has hit the ground running in part because he feels he has limited time to accomplish his goals.
“You have much less time in these jobs than you think you’re going to have, so the best time to do something you want to do is yesterday,” he told a policy meeting convened by the Atlantic May 23.
“So we’ve done that; we’ve been pushing on things.”
Gottlieb noted he’s been able to move on a number of projects because he’s been able to “leverage the expertise” at FDA. (Also see "Initiator Or Facilitator? Gottlieb Reflects On First Year As Head Of US FDA" - Pink Sheet, 11 May, 2018.)
“I can come in with the broad outlines of what I want to accomplish thematically but the actual ideas need to come from the professional staff and the organization, and we’ve practiced that. I think that’s why we’ve been able to come up with a lot of new initiatives and put things out quickly and aggressively and really try to seize on our agenda.”
In the year since his swearing-in as commissioner, Gottlieb has advanced approaches to enhancing generic drug competition, with the ultimate aim of lowering drug prices. He has focused on measures to prevent opioid addiction and is working to make the drug development process less costly, among other highlights.
Gottlieb is one of the more popular members of the Administration on both ends of the political spectrum and he has given no indication that he plans a short stay at FDA, but his comments about running against time highlight the unpredictable nature of the job of a political appointee.
He has also been a prominent Administration voice on drug pricing reforms, even those that are not in FDA's purview, drawing on his deep knowledge of the prescription drug market. (Also see "A World Without Rebates: Is FDA’s Gottlieb Offering New Vision?" - Pink Sheet, 9 May, 2018.)
Overall Gottlieb has cultivated a high profile with frequent public appearances and speeches. He is one of the more popular members of the Administration on both ends of the political spectrum so would seem to have good job security. And he has given no indication that he plans a short stay at the FDA.
But his comments about running against time highlight the unpredictable nature of the job of a political appointee. They also reflect his past experience at the agency. Gottlieb’s previous stints at FDA spanned five years at the agency and he worked for three different commissioners.
They include Mark McClellan, who served from November 2002 to March 2004, Lester Crawford, who was named acting commissioner in 2004 before serving as commissioner from July to September 2005, and Andrew von Eschenbach, who was named acting commissioner in September 2005 and then served as commissioner from December 2006 to January 2009.
McClellan and Crawford each served as commissioner for less than two years, but for different reasons. McClellan left to become administrator at the Centers for Medicare and Medicaid Services, and Crawford's abrupt departure was followed by revelations about his ownership of stock in regulated companies.
Still, their experience showed the job can be relatively short term. "I learned a lot of lessons" about FDA from working there before, Gottlieb observed, knowledge that also helped him accomplish so much in the time he's been commissioner.