GPhA responds to Senate HELP committee’s GDUFA hearing

The Generic Pharmaceutical Association on Thursday responded to a recent hearing held by the U.S. Senate Committee on Health, Education, Labor and Pensions. The hearings concerned the Generic Drug User Fee Amendments and the potential to accelerate access to generic drugs. 

 

“The association is also pleased that FDA and some Senators today recognized the need to limit impediments to generic competition, particularly the misuse of shared Risk Evaluation and Mitigation Strategies (REMS) programs designed to protect patient safety,” GPhA’s SVP sciences and regulatory affairs David Gaugh said. 

 

The organization also praised the FDA’s Center for Drug Evaluation and Research director Dr. Janet Woodcock for pledging to take action to clear a backlog of generic drugs awaiting approval. 

 

“Too many generic drug applications, including potential first generics, have been sitting with the Agency for many years before being picked up by a reviewer,” Gaugh said. “These delays contribute significantly to rising health care costs and impact access to pharmaceuticals for millions of patients.”

 

Additionally, GPhA commented on the lack of clear criteria from the FDA on what sort of quality improvements it has recently called for, and expressed concern that applications received before quality standards changes might be rejected based on these criteria. 

 

“GPhA supports submission of complete ANDAs to promote an efficient FDA review process and stands ready to collaborate with FDA,” Gaugh said. “However, there must be a clear and objective definition and criteria for ANDA “quality” in order to evaluate the scope and nature of the problem and develop strategies to address the Agency’s concern.”