Accelerated Approval Reforms in 2023 Omnibus

On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023 (“the Omnibus”) into law. In addition to providing federal funding for FY 2023, the Omnibus bill included several noteworthy healthcare-related provisions, such as reforms to the FDA Accelerated Approval Program. Section 3210 of the Omnibus “modernizes” the Accelerated Approval Program, which was established in 1992 and codified in 2012 to expedite approval of drugs that address a serious condition “associated with morbidity that has substantial impact on day-to-day functioning,” offer “meaningful advantage over available therapy,” and demonstrate an “effect on an endpoint that is reasonably likely to predict clinical benefit.” 

The reforms in the Omnibus attempt to address some of the most serious concerns of lawmakers, patient advocates, and other stakeholders about use of the program. Reforms include changes to the process for revoking accelerated approval, drug sponsor requirements, FDA requirements, and enforcement mechanisms. However, many questions remain about how aggressively the FDA will use its new authorities and how drug sponsors will respond to new post-approval trial requirements.