With hun­dreds of mil­lions spent on failed ac­cel­er­at­ed ap­provals, re­searchers call for faster FDA with­drawals

Be­tween 2017 and 2019, Medicare spent more than $220 mil­lion on can­cer drugs for which the in­di­ca­tions were ei­ther vol­un­tar­i­ly pulled by their ap­pli­cants or FDA’s on­col­o­gy ad­comm had rec­om­mend­ed their with­draw­al.

That kind of mas­sive spend­ing on can­cer drugs lack­ing over­all sur­vival ben­e­fit is waste­ful and risks harm­ing peo­ple’s health, a re­search let­ter pub­lished in JA­MA In­ter­nal Med­i­cine on Mon­day said. The re­searchers from Har­vard and the Lon­don School of Eco­nom­ics called on the FDA to move faster in both re­quir­ing time­ly post­mar­ket­ing tri­als and ac­cel­er­at­ing the speed in pulling these dan­gling ap­provals when the con­fir­ma­to­ry stud­ies fail.

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