More on PDUFA

BIO's breakthrough agenda

WASHINGTON - In addition to collaborating with PhARMA in negotiations with the FDA over the Prescription Drug User Fee Act, the Biotechnology Industry Organization has proposed to restructure the FDA's review process for "breakthrough" drugs, calling for initial market approvals based on "short form" applications, surrogate end points and limitations on reviews by advisory committees.

The plan, a "Proposal to Create an Accelerated Study and Approval Partnership (A.S.A.P.)", was informally presented to FDA last summer and then formally proposed as part of the PDUFA negotiations three weeks ago. It is intended to merge and improve the four mechanisms FDA has created to get breakthrough products to patients more rapidly: Treatment INDs; parallel track approvals; Subpart E of the IND regulations; and accelerated approval.