Industry Groups Applaud GDUFA Agreement

Industry organizations applauded the agreements reached by FDA and representatives of the generic drug manufacturing industry on reauthorization of the Generic Drug User Fee Amendments (GDUFA) for a new five-year period, covering FY2018 to FY2022.

“GPhA and its members are pleased to conclude the first reauthorization negotiations to update the Generic Drug User Fee Amendments (GDUFA). The commitments outlined in GDUFA II enable the FDA to continue delivering on its promise to protect public health by ensuring access to safe and effective generic medicines,” said David Gaugh, senior vice president, sciences and regulatory affairs, Generic Pharmaceutical Association in a statement.

 “GPhA is optimistic that the provisions of this agreement will streamline approvals by assigning goal dates to all ANDAs to assure that no submissions from GDUFA I are left behind. It will also provide the FDA with additional resources, improving transparency and accountability in order to enhance the ability of the FDA to meet GDUFA II goals. Process changes and staff additions have been positive steps thus far, and the addition of enhanced performance reporting sets an even stronger foundation for translating FDA actions on generic applications to approvals,” he said.

Gil Roth, president of the Pharma & Biopharma Outsourcing Association (PBOA), noted in a statement, “The PBOA hails the successful conclusion of the GDUFA II negotiation, and we believe that industry, the FDA, and patients will see great benefits from the program during the next five-year period. PBOA’s presence at the negotiating table ensured that contract manufacturing organizations (CMOs) were represented in the new iteration of this critical program. We look forward to working with the FDA and industry in the years ahead.”

Sources: Generic Pharmaceutical AssociationPharma & Biopharma Outsourcing Association