Rumor mill adds Joseph Gulfo to Trump's shortlist for FDA commissioner

Donald Trump
Dr. Joseph Gulfo is an advocate of approving drugs based on safety and surrogate efficacy data.

If reports are to be believed, the latest addition to Trump's list of possible FDA commissioners is Dr. Joseph Gulfo, an outspoken critic of the agency who has penned a manifesto for its reform.

Gulfo joins a lengthening list of possible candidates that also includes Scott Gottlieb, a former FDA staffer and partner at venture capital fund New Enterprise Associates, as well as two Silicon Valley figures: tech capitalist Jim O'Neill and Balaji Srinivasan, a specialist in computational biology and tech investor.

The new name on the list has an M.D. and an M.B.A. and currently serves as executive director of the Lewis Center for Healthcare Innovation and Technology. Gulfo has held senior roles at a number of biopharma companies in the past. His career record adds to the sense that Trump is determined to place tech/biotech entrepreneurs into the upper echelons of the FDA.

Gulfo has not commented publicly on his candidacy, but made it clear over the last few weeks that he would be interested in the job. He tweeted that he would "be honored to serve [President Trump] and bring real reform to the FDA" and that "fixing FDA is literally a matter of life and death."

STAT News reported that Gulfo has already met with transition team officials and outside advisers to discuss the FDA commissioner job.

Gulfo has plenty to say about the agency, and co-authored a paper last year arguing the FDA has become too restrictive. He said the agency has been going beyond its bounds in approving drugs only on the back of hard clinical endpoints such as disease outcomes and survival in an 'average' patient, rather than adhering to "the safety and effectiveness standards that are set out in the law," according to the document.

It also said new drugs should be approvable based on biomarker data alone—provided they are shown to be safe—as their usefulness is best demonstrated in "real-world, post-market settings."

In that respect, Gulfo does not go as far as O'Neill, who has argued in the past that drugs shown to be safe should be approved regardless of any evidence of efficacy. Gulfo insisted that his plans would not result in a lowering of FDA standards but would force the agency to operate in accordance with the law.

Rumors of Gulfo's candidacy came as Stephen Ostroff, FDA's deputy commissioner for foods and veterinary medicine, moved up to the role of acting commissioner after Robert Califf vacated the post on Jan. 20, in line with the traditional process as Trump was inaugurated as the 45th president.

Ostroff is no stranger to the task, having also stepped in as acting FDA commissioner for several months in 2015-2016 after Califf's predecessor, Margaret Hamburg, left the agency.

Califf's parting comments to Trump included a warning not to place business and politics above science when it comes to regulating drugs. Some might argue that judging by the new president's rumored list of candidates for the role, he has other ideas.