JUNE 1, 2026
Report argues FDA effectiveness reviews cost trillions and delay patient access to new treatments
A new report 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. The report was co-authored by economist Tomas Philipson, a former acting chairman of the White House Council of Economic Advisers. It argues that most of the decade-long drug approval process is spent on effectiveness trials rather than safety evaluations.
The report contends that the FDA's current drug approval process takes roughly a decade from start to finish and that the bulk of that time is devoted to establishing effectiveness rather than safety. Philipson, in an interview with Fox News Digital, said, "Most of that time is not spent on safety. Most of that time is spent on effectiveness trials."
The authors estimate that accelerating approvals by one to six years could generate trillions of dollars in economic value by bringing new drugs, biologics, and medical devices to patients sooner and by strengthening incentives for medical innovation. The report does not specify a methodology for how the $10 trillion figure was derived, and no independent expert assessment of that estimate appeared in the available coverage.
The report also argues that faster approvals could reduce prescription drug costs by increasing competition among manufacturers. Philipson stated, "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."