Does the FDA’s ‘breakthrough’ drug program need to be reformed? Harvard skeptics say yes
Of all the expedited review programs that the FDA has set up, none are as popular as the “breakthrough” therapy designation. And a group of high-profile skeptics says that has created some problems that need to be addressed.
Writing in the New England Journal of Medicine, Harvard’s Jonathan Darrow, Jerry Avorn and Aaron Kesselheim spell out how the BTD program has taken hold in the nearly 6 years since it was created by Congress, with each passing year scoring higher on the percentage of new drug approvals going to a breakthrough therapy.
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