FDA reaches agreement with generics industry on new GDUFA commitments

WASHINGTON — The Food and Drug Administration 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.

“GPhA and its members are pleased to conclude the first reauthorization negotiations to update the Generic Drug User Fee Amendments," stated David Gaugh, SVP sciences and regulatory affairs, GPhA. "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 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," added Gil Roth, president  Pharma & Biopharma Outsourcing Association. "PBOA’s presence at the negotiating table ensured that Contract Manufacturing Organizations were represented in the new iteration of this critical program.”

The generics industry 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.

GDUFA I was passed in 2012 as part of the Food and Drug Administration Safety and Innovation Act 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.