Lawmakers are under pressure this month to decide whether to proceed with proposed reforms to the FDA accelerated approval pathway for medicines, including the need for speedier confirmatorytrials. PDUFA FDALaw
US lawmakers are under pressure this month to decide whether to proceed with reforms to the accelerated approval pathway for medicines, with advocates arguing for a need for speedier confirmatory trials.
There have been moves to incorporate this into the Prescription Drug User Fee Act , which is in the process of being reauthorized. The current law expires on September 30. It is considered to be a must-pass bill, because PDUFA has resulted in a steady stream of funding from pharma for the FDA's review division.
However, Sen. Richard Burr has proposed leaving this provision out of the bill, raising concerns among some advocates that the changes to the accelerated approvals pathway may be abandoned this year. "We went from a bipartisan package with support for these reforms to now a conversation about stripping all that from the user fee legislation," Reshma Ramachandran, MD, MPP, MHS, who serves as the chair of the group's FDA Task Force, toldThe House in June passed a reauthorization of PDUFA that includes provisions meant to beef up the FDA's management of accelerated approvals.
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