The United States Food and Drug Administration (FDA) initiated the FDA Accelerated Approval Program in 1992 to allow faster approval of drugs for serious conditions that fill an unmet medical need.
If the drug later proves unable to demonstrate clinical benefit to patients, the FDA may withdraw approval.
[3] In 2022 Congress investigated the accelerated passage and approval of the Alzheimers drug Aduhelm, manufactured by Biogen and being marketed at $56,000 per patient a year.
They found that the FDA inappropriately collaborated with the maker when it granted accelerated approval and that it was released in June 2021 despite concerns raised by experts about the inconsistency of the drug's clinical data.
According to the report, Biogen knew its $56,000 launch price was "unjustifiably high," but company executives wanted to "make history" and "establish Aduhelm as one of the top pharmaceutical launches of all time.