Competing Incentives of the FDA’s Accelerated Drug Approval

MedPage Today November 9, 2023
By Jeremy Faust, Emily Hutto

— Experts weigh drug availability against possible suboptimal outcomes

In part 1 of this Instagram Live interview, Jeremy Faust, MD, editor-in-chief of MedPage Today, sits down to talk with Holly Fernandez Lynch, JD, MBe, assistant professor of medical ethics and health policy at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, and Aaron Kesselheim, MD, JD, MPH, director of the Program on Regulation, Therapeutics, and Law (PORTAL) of Harvard Medical School and Brigham & Women’s Hospital in Boston, about the FDA’s accelerated drug approval process.

These experts discuss successes of accelerated approval, challenges of confirmatory trials, and the competing incentives faced by patients, pharmaceutical companies, and the FDA itself.

The following is a transcript of their...

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