FDA delays cost Americans trillions and slow lifesaving drugs, new report says
FDA fast-tracks pancreatic cancer drug daraxonrasib
Family and emergency medicine physician Dr. Janette Nesheiwat discusses how artificial intelligence could help detect pancreatic cancer earlier and the FDA fast-tracking the drug daraxonrasib on ‘Fox Report.’
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A new report argues that speeding up Food and Drug Administration reviews could unlock trillions of dollars in economic value and get lifesaving treatments to patients faster.
“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.”
The paper, titled “The Multi-Trillion Dollar Opportunity in Reforming the FDA,” estimates that cutting FDA effectiveness-review timelines by one year could generate more than $10 trillion in economic value by getting new treatments to patients sooner and encouraging additional medical innovation.
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The report argues that speeding up drug approvals could help reduce prescription costs by boosting competition among manufacturers. (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 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 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)
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.
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The authors propose reforms including greater use of artificial intelligence in drug reviews. (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 and broader access to “right to try” programs.
