Dr. Joseph Gulfo in the running to lead FDA

Joseph Gulfo, MD, has talked to presidential transition team officials and advisers about the Food and Drug Administration commissioner post, STAT reported.

Dr. Gulfo's contenders include Scott Gottlieb, MD, a former FDA deputy director, and Jim O'Neill, managing director at Silicon Valley investment firm Mithril Capital Management. Dr. Gulfo did not provide a comment, according to the report, though he has been extremely vocal in his opinions on the FDA.

He has been compared to the late Justice Antonin Scalia in that he is an "originalist" in how he interprets laws governing the FDA's purpose. In a 2016 interview for the Boston Business Journal, Dr. Gulfo said the FDA no longer simply ensures drugs are safe and effective, but it now also attempts to determine if a drug has long-term benefits for patients, which oversteps its original purpose. Dr. Gulfo believes long-term benefit is derived from consumer use, not clinical trials, according to the Boston Business Journal.

Most recently, he penned an op-ed for The Hill about how just 22 new drugs were approved by the FDA last year, 41 percent of which are for rare diseases. "This is shameful," he wrote, because no new drugs were created for common conditions that afflict millions of Americans.

"The solution is to return FDA's focus to safety and effectiveness. Right now, it's focused on long-term endpoints like survival and outcomes, which not only require large, lengthy, and expensive clinical trials, but also are wrought with uncontrolled variables that mask benefits in the aggregate and, especially, in individual patients," Dr. Gulfo wrote.

Though he made no mention in the Op-Ed of his candidacy for FDA commissioner, he wrote, "The way to fix this problem is with effective strong leadership at the FDA to change the culture or fear that has driven the shift to rare disease approval."


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