UP Senior Fellow Tomas Philipson has just expanded his groundbreaking work on the economics of curing cancer to develop a reform agenda for the FDA to speed up the deadly slow drug approval process for a wide array of some 10,000 diseases.
Tomas explains in the WSJ:
In our analysis, we find that speeding up development by one to six years for FDA-approved medical products (small-molecule drugs, biologics and medical devices) would unlock between $10 trillion and $49 trillion in economic value…
The FDA could unleash trillions in value by taking six steps to shorten effectiveness assessments, akin to the methods of Operation Warp Speed during Covid-19. First, it could improve disease-specific guidance on the use of externally controlled trials and synthetic control arms. Second, it could extend the use of concurrent reviews, now limited to oncology products, to judge products for all serious and life-threatening conditions.
Third, the FDA and the Centers for Medicare and Medicaid Services could jointly publish a coordinated evidence framework to speed up market access. Fourth, the FDA could speed up premarket effectiveness approval through better incentives for manufacturers to report evidence of their products’ efficacy after market launch. Fifth, the FDA could rely more on artificial intelligence for approvals and postmarket assessments. Sixth, existing “right to try” regulations could be strengthened to enable more-widespread use.
The full paper, published by our advocacy affiliate Unleash Prosperity Now, is available here:
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