A bill that makes it easier for the Food and Drug Administration to withdraw drugs that were approved under an accelerated timeline also dropped provisions the industry had opposed, according to three drug lobbyists.
The legislation was spurred by the fracas over the Alzheimer’s drug Aduhelm, which received a so-called accelerated approval. Nearly every member of an FDA advisory panel voted against approving the Biogen drug, though many advocates for patients with debilitating conditions praised FDA for the approval. Medicare officials subsequently refused to pay for the drug outside of clinical trials.
The FDA uses accelerated approvals to speed availability of promising drugs for serious conditions. In return, companies agree to conduct clinical research that confirms drugs extend lives, but companies often miss deadlines by years. Under the bill, those missed deadlines can now be ground for the FDA to withdraw approval.
However, the lobbyists said, gone from the bill is the requirement that companies enroll clinical trials by the time of accelerated approvals. Lawmakers also stripped a requirement that product labels disclose that products have been approved using the accelerated path. Labels are a primary way the FDA communicates with physicians about drugs.
The industry did lose a measure that would have explicitly stated that drug companies may use data from medical claims and insurance data to help confirm that drugs work in post-market studies.
The accelerated approval reforms are part of a package of health policies that lawmakers hope to pass as part of legislation that funds the government. House lawmakers in both parties worked for months on the accelerated approval policies, and the original plan was to include them in a bill that reauthorized industry user fees, which that fund more than half the agency’sof FDA’s operating budget.