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Statement by David Gaugh, Senior Vice President, Sciences and Regulatory Affairs, GPhA, Regarding the Senate HELP Hearing on GDUFA

Contact: Steve Arnoff 202.249.7113 

WASHINGTON, DC (January 28, 2016) — “The Generic Pharmaceutical Association (GPhA) is pleased that Dr. Janet Woodcock, Director, Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), highlighted the FDA pledge to clear the growing backlog of generic drugs awaiting FDA approval in today’s Senate HELP hearing, Generic Drug User Fee Amendments: Accelerating 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.

With more than 3,800 generic applications stalled at FDA, it is increasingly important to distinguish between actions taken on an application and approval of that application. Meaningful actions are important and progress toward the stated metric of agency actions taken on 90% of backlog applications is laudable. GPhA is eager to see these actions translate to approvals.

In 2011 when GDUFA began, median review time to approval was at 30 months. Since then, median review times increased to 31 months in FY2012, 36 months in FY2013 and an estimated 42 months in FY2014. At the industry’s best estimate, current fiscal year median approval times will be 48 months — the slowest it has ever been.

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. These delays contribute significantly to rising health care costs and impact access to pharmaceuticals for millions of patients.

FDA has expressed concerns regarding the quality of generic drug applications and GPhA is supportive of efforts to improve submissions. However, the agency has not defined or provided data on what constitutes “quality” or completeness of generic drug applications. Further, FDA continues to deem applications submitted three to four years ago to be of “poor quality” because they don’t meet new, more recent standards updated while these applications sit in the backlog.

GPhA supports submission of complete ANDAs to promote an efficient FDA review process and stands ready to collaborate with FDA. 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.

GPhA looks forward to working with FDA to strengthen GDUFA, particularly as we enter the second round of user fee agreement negotiations. Through ongoing collaboration with FDA, we can continue to progress on our shared commitment to core GDUFA goals to improve safety, access and transparency and ensure that millions of patients have timely access to safe and effective generic drugs.”

About GPhA

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at Follow us on twitter: @gpha.