Cutting just one year from the Food and Drug Administration’s drug review process could create more than $10 trillion in economic value while getting lifesaving medicines to patients faster, according to a new report calling for major FDA reforms.
The report, The Multi-Trillion Dollar Opportunity in Reforming the FDA, published by the free-market policy group Unleash Prosperity, argues that lengthy effectiveness reviews, not safety testing, account for much of the agency’s approval timeline.
Its authors estimate that trimming those reviews by one year would accelerate patient access to new treatments while encouraging greater investment in medical innovation.
“It takes about a decade from start to finish to come through FDA,” economist and former acting chairman of the White House Council of Economic Advisers Tomas Philipson told Fox News Digital in an interview. “Most of that time is not spent on safety. Most of it time is spent on effectiveness trials.”
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Philipson argued that most delays in the drug approval process stem from determining effectiveness rather than safety.
“FDA is charged by Congress to enhance both safety and effectiveness of new drugs,” Philipson said. “People recognize the role of the government potentially ensuring safety and consumer protection, but it’s a unique role that FDA has of ensuring effectiveness.”
He also argued that faster approvals could help lower prescription drug costs by increasing competition among manufacturers.
“Reforming FDA would have a big impact on drug affordability for patients because it would allow for far more competition between drugs that come out faster,” he said.
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The report estimates that accelerating approvals by one to six years could generate trillions in economic value through earlier access to drugs, biologics and medical devices, as well as stronger incentives for innovation.
The authors also warn that China’s faster, lower-cost clinical trial system could lure investment and drug development activity away from the United States.
Philipson said the competitive challenge from China underscores the need for policymakers to rethink the pace of FDA approvals.
“I think there’s a huge role for the president here to push an analogous effort to what he did with Operation Warp Speed during COVID,” Philipson said. “It’s equally urgent for other patient groups who don’t have COVID but other diseases.”
The authors propose reforms including greater use of artificial intelligence in drug reviews, faster clinical trial designs and broader access to “right to try” programs.
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