Generic Drug User Fee Act Nearing Finalization

The draft of the Generic Drug User Fee Act (GDUFA) entered its last lap in December before going to Congress for approval with a final public airing of FDA’s “goals letter” at its White Oak, Maryland headquarters that produced little public comment.  Written comments on the draft “goals letter” are due by January 6, 2012.

The small number of questions and lack of industry presentations at the meeting speak to the thorough process used to forge the GDUFA proposal.  [Editor’s note:  A summary of the FDA/industry negotiation process on generic drug user fees and the results by Office of Generic Drugs (OGD) Acting Director Keith Webber at the Generic Pharmaceutical Associations’ annual fall technical conference in October is provided below.]

The meeting, scheduled for seven hours with ample time allotted for individual and association presentations, lasted just over an hour.  Only FDA presented – no individuals or associations – and the Q&A session was over in 15 minutes.

The FDA draft discussed at the meeting is the result of five public meetings held beginning in September, 2010 and 18 face-to-face meetings between the agency and three key trade associations held between February and September of 2011.  Represented in the face-to-face meetings were the GPhA, the European Fine Chemicals Group (EFCG), and the Society of Chemical Manufacturers and Affiliates (SOCMA) Bulk Pharmaceutical Task Force (BPTF).

At the December meeting, FDA Office of Policy Senior Scientific Policy Analyst Peter Beckerman characterized the process used to produce the draft as “a model for how a regulator can utilize public input and work with industry to craft a program to provide needed resources and strengthen a critical public health program.”

[More on the GDUFA negotiations and the FDA proposal is provided for subscribers here.  Nonsubscribers can purchase the full article for $195 by contacting Jonathan Trethowan (  For subscription/license information, click here.]