President Donald Trump is planning to take the ax to Food and Drug Administration regulations. “[We’re] going to be streamlining the process so that, from your standpoint, when you have a drug, you can actually get it approved instead of waiting for many, many years,” he told a collection of Big Pharma CEOs, including the chief executives of Merck (MRK), Novartis (NVS), and Johnson & Johnson (JNJ), during a White House meeting earlier this year.
It’s a cause the President has been championing for a while. Trump has promised to roll back 75% to 80% of the agency’s regulations and doubled down on the vow during his February address to a joint session of Congress. “If we slash the restraints, not just at the FDA but across our government, then we will be blessed with far more miracles just like Megan,” he said, referring to a young woman in the audience suffering from a rare disease and whose life was saved thanks to a breakthrough treatment.
But while plenty of executives see the value of less regulatory red tape, they’re not cheering the prospect of scrapping all the rules. Part of the reason is that a drug-approval process perceived as rushed could cause insurance companies to balk at reimbursing treatments that aren’t proven effective. Then there’s the barrier to entry that regulations represent to would-be competitors. Industry heavyweight Merck’s R&D head Roger Perlmutter has said the FDA’s balance right now is about right, and several biotech execs have publicly urged caution.
One change to the FDA that the industry does like? Trump’s pick for commissioner, Scott Gottlieb, who gets high marks for plans to trim red tape—but not too much.
A version of this article appears in the April 1, 2017 issue of Coins2Day with the headline “Next Up for FDA Approval: Fewer FDA Rules.”
