WHY GOTTLIEB SHOULD STAY AT FDA
BY STEVE USDIN, WASHINGTON EDITOR, BIOCENTURY
Reports that FDA Commissioner Scott Gottlieb tops President Donald Trump’s list for replacing ousted HHS Secretary Tom Price are reverberating around the Washington echo chamber. The speculation has made its way into so many articles, blogs, tweets and cellphone conversations overheard on the Red Line Metro cars frequented by lobbyists, lawyers and journalists that it has acquired a patina of credibility, even inevitability.
I don’t claim to know whether the job will be offered to Gottlieb or if he would accept it. I do think the interests of patients, FDA, regulated industry and, most likely, Gottlieb himself would be best served if he remains at FDA. Here are four reasons why:
1. FDA NEEDS A STRONG PERMANENT L EADER
FDA needs stable leadership to produce the regulatory innovation that can turn today’s scientific advances into tomorrow’s medicines.
While the agency can maintain critical functions on autopilot, only a congressionally confirmed leader can break new ground or take controversial steps. Gottlieb has started to take FDA in new directions, for example by making public health arguments for lowering drug prices by tackling pharma company “gamesmanship,” and for making cigarettes less addictive. He has announced plans to release a plan for advancing biomedical innovation that will go beyond the requirements in the recently enacted 21st Century Cures Act and FDA Reauthorization Act.
These projects reflect Gottlieb’s personal experience and vision. It will take years to get them started and on a firm footing. They would likely wither if he departed.
2. FDA NEEDS A COMPETENT LEADER
While there certainly are other individuals with the necessary experience and competence to lead FDA, there is no reason to believe they would be nominated if Gottlieb departed.
When Gottlieb was nominated, serious contenders for the position included individuals who want to discard the standards and principles that have made FDA the gold standard for medical product regulation. These guys are still out there, tanned, rested and ready for their opportunity to dismantle the regulatory state and make the world safe for purveyors of snake oil.
3. GOTTLIEB’S NOT RIGH T FOR HHS
Gottlieb lacks the kind of experience required to successfully manage an organization with a trillion-dollar budget and 80,000 employees.
Someone who has been a state governor or headed a state health department or possibly a large university system would be better qualified to deal with the massive budgets, to manage government departments with diverse missions and to placate members of Congress with competing interests.
4. HEADING HHS IS A THANKLESS TASK
The person who steps into Price’s shoes will be pinned between a mercurial president prone to humiliating cabinet secretaries, and feuding Republican factions in Congress that are promoting incompatible and impossible healthcare agendas.
The next HHS secretary will be castigated by Republicans for failing to strangle the Affordable Care Act and vilified by Democrats for failing to shore it up. The secretary also will have to defend the Trump administration’s proposals to slash funding for public health and biomedical research. It is difficult to imagine anyone coming out of the job with their integrity and self-respect intact.
If he departs now, Gottlieb will leave no mark behind at FDA, and there aren’t great prospects for advancing the public good at HHS. In contrast, based on his current trajectory, if he stays on the job, Gottlieb is on track to leave with a strong, positive legacy.