Opinion: Congress should fix FDA’s accelerated approval program for the next 30 years
The Food and Drug Administration’s approval of the Alzheimer’s drug Aduhelm has sparked a broader debate on the merits and limitations of the FDA’s accelerated approval program. This debate — and its timing — are important.
The FDA issued its accelerated approval regulation nearly 30 years ago, and has since applied this approach for more than 200 new drug indications. This program allows for faster approval of drugs for severe conditions based on markers predicting clinical benefit, on the rationale that patients with no alternatives need options sooner, not later.
