The report estimates that reforming the FDA could unlock billions in economic value
Unleash Prosperity economist Tomas Philipson says long FDA approval times are delaying life-saving treatments and calls for a COVID-era “Operation Warp Speed” model to accelerate patient access to new drugs.
Cutting just one year from the Food and Drug Administration's drug review process could create more than $10 billion in economic value while getting life-saving drugs to patients faster, according to a new report calling for major FDA reforms.
The report, A Multi-Trillion Dollar Opportunity in Reforming the FDA, published by the free-market policy group Unleash Prosperity, argues that lengthy efficacy reviews, not safety evaluations, are part of much of the agency's approval process.
Its authors estimate that cutting those reviews by one year would speed patient access to new treatments while encouraging greater investment in medical innovation.
“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.”
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The report says speeding up drug approvals can help reduce drug costs by increasing competition between manufacturers. (iStock / 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 efficacy 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. (Photos by Issam Ahmed/AFP/Getty)
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. (iStock / 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.
