Generic Drug User Fee Act II: The positive features for generic drug industry

Abstract

The US Food and Drug Administration (FDA) and the Generic Drug Industry have completed negotiations for the reauthorization of the Generic Drug User Fee Act (GDUFA II). The agreement is now with Congress, which must write it into legislation in order for it to become effective. GDUFA II addresses questions that arose with the implementation of GDUFA I. One of the primary concerns with GDUFA I was that it did not provide any relief for small business whereas GDUFA II addresses relief for small business. GDUFA II has carved out a subcategory for Contract Manufacturing Organizations (CMOs), which are independent facilities contracted by abbreviated new drug application (ANDA) sponsors to manufacture their generic drugs. GDUFA II will have a fee structure very different from GDUFA I. The distribution of user fee categories will show the shift from facilities to applications and the addition of two new user types. GDUFA II is structured to allow FDA to continue on the path forward to improve patient access to quality and affordable generic drugs. As per the GDUFA II commitment, the FDA will work with generic drug makers on a closer and more timely basis to speed the review of ANDAs.