On September 17, 2014 the Food and Drug Administration (“FDA”) is holding a public hearing at the College Park Marriot Hotel and Conference Center, in Hyattsville, MD, to discuss the Agency’s implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA) and its obligations under GDUFA as set forth in the GDUFA Commitment Letter accompanying the legislation. The central purpose of GDUFA is to help speed the delivery of safe and effective generic drugs to the public and to reduce costs to industry. GDUFA requires manufacturers to pay a user fee to supplement FDA’s costs of reviewing generic drug applications and inspecting facilities. Per the GDUFA Commitment Letter, the user fees enable the Agency to reduce a backlog of pending applications, cut the average time required to review generic drug applications for safety, and increase risk-based inspections.

At the public hearing, FDA will focus on two particular aspects of GDUFA: (1) soliciting public comment on the five draft guidance documents that FDA has issued to facilitate implementation of the law, and (2) recommending future policy priorities, including recommendations for additional guidance topics to facilitate GDUFA implementation (e.g., 180-day generic drug exclusivity, and potential first generics). The meeting will provide an opportunity for public input from all interested parties, including regulated industry, consumers, patients, caregivers, health care professionals, and patient groups, on future FDA policy priorities.

To register for the hearing or to make a request to make an oral presentation at the hearing, send an email to GenericDrugPolicy@fda.hhs.gov, by September 3, 2014, that includes the complete contact information for each attendee, including name, title, affiliation, address, email address and telephone number. FDA will accept electronic and written comments on this topic after the hearing until October 13, 2014. Electronic comments may be submitted at www.regulations.gov.

About the Authors: Jennifer Pike (Associate) and Vicki Morris (Associate) are both members of the firm’s Life Sciences Health Industry Group and are based in our Washington, D.C. office.