STAT spoke with pharmaceutical insiders, physicians, Wall Street analysts and FDA veterans about the potential benefits and consequences of President Donald Trump's plan to deregulate the FDA and speed up the approval process for drugs and devices.
Here are four reactions to the president's call for a deregulated FDA.
A Mayo Clinic physician
"It would be chaotic," said David Knopman, MD, a neurologist at the Mayo Clinic in Rochester, Minn. Dr. Knopman admits speeding up the development of new medications is a commendable goal, but said exposing patients to costly, ineffective and potentially dangerous drugs could be disastrous, according to the report.
"It would be a terrible thing for our patients and their families," Dr. Knopman said. "There is no intermediate position."
A pharma CEO
"I actually am against making it really easy to get your drug approved," Regeneron Pharmaceuticals CEO Leonard Schleifer, MD, PhD, said at the Forbes Healthcare Summit in December. "… Having a high bar is a good thing in my opinion, because it allows innovators to compete."
A Wall Street Analyst
"There are just too many companies I've seen that have tried to pull fast ones on the FDA and on investors," said Brian Skorney, a biotech equities analyst at Baird. "With lower standards, you just know they're going to try to sucker patients and physicians."
A former FDA official
"Maybe 2 percent of the people on the whole planet get what [the FDA does]," said David Gortler, former FDA medical officer who now works as a consultant at Former FDA. "As a conservative, I'm all for less regulation, but I'm not prepared to let Jane and John Q Public make decisions about pharmacogenomics and pharmacokinetics on their own."
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