The report estimates that reforming the FDA could unlock billions in economic value
FDA fast-tracks pancreatic cancer drug daraxonrasib
Family and emergency medicine doctor Dr. Janette Nesheiwat discusses how artificial intelligence can help detect pancreatic cancer early and the FDA’s fast-tracking the drug daraxonrasib on ‘Fox Report.’
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A new report says speeding up Food and Drug Administration review could unlock billions of dollars in economic value and get life-saving treatments to patients faster.
“It takes almost a decade from start to finish to implement the FDA,” economist and former acting chairman of the White House Council of Economic Advisers Thomas Philipson told Fox News Digital in an interview. “Most of that time is not spent on security. Most of that time is spent on testing effectiveness.”
The paper, titled “The Multi-Trillion Dollar Opportunity in Reforming the FDA,” estimates that cutting FDA effectiveness review times by one year could generate more than $10 trillion in economic value by getting new treatments to patients faster and spurring more medical innovation.
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The report says speeding up drug approvals can help reduce drug costs by increasing competition between manufacturers. (Stock)
Philipson argued that most delays in the drug approval process come from determining efficacy rather than safety.
“The FDA is charged by Congress to improve both the safety and effectiveness of new drugs,” Philipson said. “People recognize the government’s strong role in ensuring consumer safety and protection, but it’s a unique role that the FDA has to ensure efficiency.”
He also said that faster approval could help reduce the cost of prescription drugs by increasing competition between manufacturers.
“Reforming the FDA can have a major impact on the purchase of drugs for patients because it will allow greater competition among drugs that are released quickly,” he said.
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The report also questions whether the federal government should continue to play such a large role in determining a drug’s effectiveness before it reaches the market. (Issam Ahmed/AFP)
The report estimates that speeding up approval by one to six years could generate billions in economic value through earlier access to drugs, biologics and medical devices, and stronger incentives for innovation.
The authors also warn that China’s fast, low-cost clinical trial program could attract investment and drug development work away from the United States.
Philipson said the competitive challenge from China underscores the need for policymakers to rethink the pace of FDA approval.
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The authors propose changes that include greater use of artificial intelligence in drug review. (Stock)
“I think there’s a big role for the president here to run a similar effort to what he did with Operation Warp Speed during the COVID,” Philipson said. “It is equally urgent for other groups of patients who do not have COVID but other diseases.”
The authors propose changes that include greater use of artificial intelligence in drug review, faster clinical trial designs and wider access to “right to try” programs.
