GPhA Statement Regarding the Announcement that FDA Commissioner Hamburg Will Step Down

PRESS RELEASE

“The Generic Pharmaceutical Association (GPhA) and its members applaud the significant progress made by the agency during Commissioner of Food and Drugs Dr. Margaret Hamburg’s six years leading the U.S. Food and Drug Administration. Throughout her tenure, Dr. Hamburg has been a tireless advocate for patient safety and a leader in efforts to assure that FDA decisions are guided by scientific principles.

Most notably, Commissioner Hamburg has been an advocate on the front lines for passage and implementation of the Generic Drug User Fee Amendments (GDUFA), a historic collaboration between the industry and agency that enhances drug safety, access and transparency. We look forward to working with the FDA to further strengthen GDUFA and accelerate the drug review and approval process, among other shared priorities. She has also been instrumental in the passage and implementation of the Biosimilars User Fee Amendment (BsUFA). Dr. Hamburg’s efforts have been particularly important in this area as the first biosimilars will soon be available in the United States.

GPhA and its members also support the quality culture that Commissioner Hamburg has promoted at FDA. We believe that the strong foundation she has established positions the FDA well to advance public health and ensure patient access to safe and affordable generic medicines.”