U.S. Food & Drug Administration (FDA) Generic Drug User Fee Act (GDUFA) FDA Revised MAPP Enhances Communication with Generic Drug Industry

Today the U.S. Food and Drug Administration (FDA) published Manual of Policies and Procedures (MAPP) 5200.3 Rev. 1, “Communications with Industry with Respect to Pre-GDUFA Year Three Abbreviated New Drug Applications.” The revised MAPP improves the FDA’s communications with the generic drug industry in order to facilitate the launch of generic drugs into the market so that patients can access them as soon as possible. MAPPs describe the FDA’s internal policies and are available to the public.

The FDA’s revisions to this MAPP reflect careful consideration of feedback provided by the generic drug industry. The agency’s revisions substantially expand and set responsibilities and procedures for communications between the FDA’s generic drug program staff and companies’ authorized representatives.

Launching a generic drug is a complicated process. It requires generic drug companies to achieve a number of milestones in a specified order within a certain period. Transparent communication between the FDA and generic drug companies is needed to facilitate this process. MAPP 5200.3 Rev. 1 enables the FDA’s generic drug program staff to proactively communicate with companies regarding the review status of their generic drug applications, and to provide advance notice of critical regulatory correspondence. These revisions will facilitate launch planning and help ensure public access to affordable, quality generic drugs at the earliest possible date.