President Donald Trump is considering Joseph Gulfo to run the US Food and Drug Administration, Stat News reports. Gulfo, who has both a medical degree and an MBA, is the executive director of the Lewis Center for Healthcare Innovation and Technology at Fairleigh Dickinson University, a fellow at the Progressive Policy Institute, and was a visiting scholar at George Mason University's Mercatus Center.
Gulfo, it adds, recently wrote about what priorities the next FDA commissioner should have. As FierceBiotech notes, he has argued the agency has become "too restrictive."
To address what they view as "mission creep," Gulfo and his co-authors from the Mercatus Center say in a 2016 article that Congress should limit FDA to evaluating the safety of drugs' intended uses; define safety as the likelihood that a drug would to led to severe harm, debilitation, or death; define effectiveness as having a positive effect on the disease; and require the agency to expand its use of surrogate endpoints. Gulfo and his co-authors argue that this would bring FDA back to the spirit of the law governing the agency.
Here, FierceBiotech notes, another candidate for the post, Jim O'Neill, takes it a step further: he has called for drugs to be approved after they pass safety tests.
Also in the running for the top FDA spot is Scott Gottlieb, a former FDA deputy director, Stat News adds.