W

ASHINGTON — Two weeks ago, Dr. Joseph Gulfo ran a panel at the Biotech Showcase in San Francisco titled, “The Trump Administration: What to expect from the FDA.”

He left out one key detail: He may end up running the place.

Gulfo, who may be the first person in political history to serve as a senior fellow at both the left-leaning Progressive Policy Institute and the conservative Mercatus Center at George Mason University, has discussed the job of FDA commissioner with at least two transition team officials and some of their outside advisers.

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Gulfo, 53, declined to comment on his candidacy, but his vast archive of publications makes his positions clear. In one article last month, he listed several priorities for Trump’s next FDA commissioner.

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To begin with, he wrote, Congress must stop humiliating the FDA at hearings. That just makes regulators defensive and more inclined to protect the status quo. “We need to show the FDA love, and support FDA staff in doing their jobs and in the decisions they make,” he wrote.

He also wrote that FDA should adopt four categories of drug approval, which he says would better follow the intent of the law than the current system. For instance, he believes the FDA should grant approval of some medicines even if they haven’t shown that they change patients’ health outcomes in the long term. Instead, he wrote, the FDA should consider whether the drugs lead to positive trends in biological parameters associated with the disease, such as glucose levels.

But Gulfo does not go as far as Jim O’Neill, a rival candidate for commissioner, who has advocated approving drugs when they’re proved safe, rather than testing them extensively for efficacy. Gulfo dismisses that approach as selling “safe snake-oil.”

Gulfo holds both an MD and an MBA and has founded numerous biopharma and medical technology companies. He now works as executive director of the Lewis Center for Healthcare Innovation and Technology at Fairleigh Dickinson University.

Trump is also said to be considering Dr. Scott Gottlieb, a former FDA deputy director, who also serves on the president’s transition team.

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  • Gulfo would be a terrific choice. He’s knowledgeable, has long experience in both academic and industry, and has the fire in the belly for reform.

  • What is his position on device approvals and safety? Would he keep the current outdated “one type fits all” system, or move to a framework for Precision Devices, with prescreening patients for immune reactivity to determine if device materials are “right for you” before being installed?

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