Generic Manufacturers Applaud Outgoing FDA Commissioner's Efforts
As news of FDA Commissioner Margaret A. Hamburg's resignation spread, pharmaceutical organizations commended her work as a patient safety advocate, particularly regarding drug approvals.
As news of FDA Commissioner Margaret A. Hamburg’s resignation spread, pharmaceutical organizations commended her work as a patient safety advocate, particularly regarding drug approvals.
“The Generic Pharmaceutical Association (GPhA) and its members applaud the significant progress made by the agency during…Dr. Margaret Hamburg’s 6 years leading the FDA,” the association said in a statement. “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.”
With Dr. Hamburg at its helm, the FDA introduced the Generic Drug User Fee Amendments of 2012 (GDUFA), requiring manufacturers to pay fees in order to offset the costs of reviewing generic drug applications and inspecting facilities. According to the FDA, the fees would allow the administration to review generic drug applications faster, reduce its backlog of pending applications, and increase the number of generic drug facility inspections.
The administration also introduced the Biosimilars User Fee Act of 2012 (BsUFA) and the Biologics Price Competition and Innovation Act of 2009 under Dr. Hamburg’s watch. The latter created a pathway to introduce biosimilar medications for FDA approval, and the former established a user fee program that supports biosimilar application review.
“Dr. Hamburg’s efforts have been particularly important in this area, as the first biosimilars will soon be available in the United States,” the GPhA said in a press release. “…We look forward to working with the FDA to further strengthen GDUFA and accelerate the drug review and approval process, among other shared priorities.”
Despite those successes, Dr. Hamburg’s focus on safety prompted a 2012 congressional report that tied drug shortages to manufacturing shutdowns at 4 major generic pharmaceutical companies. The FDA later rejected those allegations, issuing a staff report detailing the manufacturing or quality problems that led to the plant shutdowns.