The Food and Drug Administration (FDA) and the generic drug manufacturing industry—including representatives of generic pharmaceutical manufacturers, active pharmaceutical ingredient manufacturers and contract manufacturing organizations— have reached agreement on a package of program enhancements and resource commitments to reauthorize the Generic Drug User Fee Amendments of 2012 (GDUFA), which are set to expire next year.
 
The Pharma & Biopharma Outsourcing Association (PBOA) lauded the news that the FDA and industry reached agreement on reauthorization of GDUFA for a new five-year period, covering FY2018 to FY2022. PBOA was one of several industry groups that participated in GDUFA reauthorization negotiation sessions.
 
“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,” said Gil Roth, president of the PBOA. “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.”
 
GDUFA I was passed in 2012 as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) with the goals of improving safety, access and transparency within the generic sector. The new version of this industry-funded program includes key improvements, metrics and resource provisions intended to streamline the review process for Abbreviated New Drug Applications (ANDAs), enhance FDA’s inspection infrastructure, and increase accountability, while providing relief for small businesses.
 
David Gaugh, senior vice president, sciences and regulatory affairs, Generic Pharmaceutical Association (GPhA), said, “GPhA and its members are pleased to conclude the first reauthorization negotiations to update 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. The generic drug review process is largely supported and funded by industry stakeholders. These funds are applied toward streamlining and expediting the application review and approval process, improving regulatory consistency and predictability, and ensuring that millions of patients have timely access to safe and effective generic medicines.”