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.
In one article last month, he listed several priorities for Trump’s next FDA commissioner.
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 writes, 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 (read “Why Donald Trump's Putative FDA Pick Should Scare Pharma & Patients”; http://sco.lt/62EHSL), 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.”
Trump is also said to be considering Dr. Scott Gottlieb, a former FDA deputy director, who also serves on the president’s transition team (read “If Gottlieb Becomes FDA Commissioner, It Would Be First Case of FDA-Pharma-FDA Revolving Door”; http://sco.lt/7B5baT).