BioPharma Dive May 10, 2022
Jonathan Gardner

Over the past few years, the Food and Drug Administration has come increasingly under scrutiny for its program to grant speedy approvals to drugs that show early signs of benefiting patients with life-threatening diseases.

These so-called accelerated approvals have ushered in many new therapies, particularly for cancer. But they have also ginned up substantial controversy in several cases, such as with Biogen’s new Alzheimer’s medicine Aduhelm, because they brought to market high-priced therapies that weren’t proven to help people.

Drugmakers have also faced criticism for dragging their feet on the follow-up studies meant to definitively show their medicines work.

Soon, the FDA could receive new authority to compel pharmaceutical companies to follow through with these confirmatory studies and to order...

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