US drug regulators failed to follow their own guidance and practices when they approved the controversial Alzheimer’s drug Aduhelm, a congressional report said on Thursday. The US food and drug administration’s (FDA) process of approval, it said, had been “rife with irregularities”, and the FDA’s interactions with maker Biogen had been “atypical”. The report follows an 18-month regulatory review conducted by two House committees focused on the drug’s approval, pricing and marketing. Biogen, the report found, had set an “unjustifiably high” price by initially pricing Aduhelm at $56,000 a year. “The findings in this report raise serious concerns about FDA’s lapses in protocol and Biogen’s disregard of efficacy and access in the approval process for Aduhelm,” the report concluded.

Source: The Guardian January 04, 2023 03:36 UTC