Former Gottlieb Colleagues Offer Clues to His Management Style, Goals

Newly minted FDA Commissioner Scott Gottlieb comes into office immediately faced with many challenges: from hiring issues to budget concerns, drug prices and a nationwide opioid addiction crisis. But those who have worked with him say he’s the ideal man for the job.

As a protégé of Mark McClellan, FDA commissioner from 2002 to 2004, Gottlieb is likely to also approach change at the agency with an a economist’s eye — “as interested in the economic ramifications of a policy as in the policy itself,” said Marc Scheineson, now a partner at Alston and Bird LLP, who formerly worked in legislative affairs at FDA and alongside Gottlieb as an advisor.

Gottlieb will focus on the core agency missions, said Scheineson, who spoke in an FDAnews webinar, along with Wayne Pines, president of health care for APCO Worldwide consultancy and a former FDA spokesman, and Peter Pitts, co-founder and president of the Center for Medicine in the Public Interest, who also worked with Gottlieb at the FDA.

Expect to see the FDA become a partner in as well as a regulator of innovations under Gottlieb, Pitts said, and the development of a more predictable approval process and more in depth guidance.