The US FDA would be required to set up an internal council to ensure consistent application of the accelerated approval pathway under bipartisan user fee legislation introduced in the Senate on 27 May.
US FDA Accelerated Approval Council Required Under Senate User Fee Bill
Intra-agency group would be tasked with ensuring consistent use of the expedited pathway across the FDA, with duties potentially including development of best practices, product review team training, and advising on withdrawals, according to the Senate's bipartisan user fee legislation.

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Republican congressional staffers could bring a wealth of experience and strong contacts with key legislators to the FDA ahead of the next user fee reauthorization process. But will Health and Human Services Department leadership interfere?
Not all companies will be able to access joint scientific consultations under the EU Health Technology Assessment Regulation, but success is still possible for those that engage with national agencies early on, says EUCOPE’s Alexander Natz.
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Industry likely wants Grace Graham to take the FDA’s top policy and legislative role, but she may be passed over for someone more tied to HHS Secretary Robert F. Kennedy Jr.’s interests.
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In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."