How Would New Legislation Change FDA Accelerated Approval Process?

House Energy & Commerce Committee Chair Frank Pallone (D-N.J.) has introduced a new bill that would set time limits around US Food and Drug Administration (FDA) accelerated approvals. Overall, the legislation would provide the FDA with more oversight of the program’s management, particularly its process for pulling an accelerated approval that has failed to confirm clinical benefit in a timely manner.

Under Mr. Pallone’s bill, accelerated approvals would be required to expire 1 year after post-approval studies are scheduled to be completed and never later than 5 years after approval. Exceptions to the latter rule would be cases in which post-marketing studies have been completed and verified clinical benefit, or the US Department of Health and Human Services Secretary determines that adequate progress has been made.

“Under the current system, some products have been allowed to stay on the market for far too long without clinical trials that demonstrate a real clinical benefit for patients. Patients deserve to know that the drugs they are taking are safe and effective,” Mr. Pallone said in a statement.

The legislation, which would require more frequent reporting from sponsors on post-approval studies, would allow the FDA to expedite the withdrawal of an accelerated approval under the following circumstances:

• the sponsor fails to conduct any required post-approval study of the product with due diligence
• the sponsor fails to achieve agreed-upon enrollment targets, milestones, or timely study completion
• the sponsor disseminates false or misleading promotional materials with respect to the product

“The challenge for accelerated approval reform is building in enough flexibility for challenges arising in different disease areas (esp. rare disease) while simultaneously minimizing FDA discretion,” Holly Fernandez Lynch, JD, MBE, assistant professor of medical ethics at the University of Pennsylvania’s Perelman School of Medicine, wrote on Twitter.

Source: RAPS.org, March 9, 2022.