Unleash Prosperity economist Tomas Philipson argues lengthy FDA approval timelines are delaying lifesaving treatments. calls for a COVID-era "Operation Warp Speed" model to accelerate patient access to new medicines.
Cutting just one year from the Food. Drug Administration's drug review process could create more than $10 trillion in economic value while getting lifesaving medicines to patients faster, according to anew reportcalling 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. 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. 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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The report argues that speeding up drug approvals could help reduce prescription costs by boosting competition among manufacturers.(iStock / iStock)
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. consumer protection, but it's a unique role that FDA has of ensuring effectiveness."
He also argued that faster approvals could help lowerprescription drugcosts by increasing competition among manufacturers.
"Reforming FDA would have a big impact on drug affordability for patients. it would allow for far more competition between drugs that come out faster," he said.
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The report also questions whether the federal government should continue playing such a large role in determining a drug's effectiveness before it reaches the market.(Issam Ahmed/AFP / Getty Images)
The report estimates that accelerating approvals by one to six years could generate trillions in economic value through earlier access to drugs, biologics. 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. drug development activity away from the United States.
Philipson said the competitive challenge fromChinaunderscores the need for policymakers to rethink the pace of FDA approvals.
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The authors propose reforms including greater use of artificial intelligence in drug reviews.(iStock / iStock)
"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. broader access to "right to try" programs.
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