Statement from GPhA President and CEO Kathleen Jaeger on FDA’s Generic Drug Initiative
ARLINGTON, VA, October 4, 2007 -- Generic Pharmaceutical Association (GPhA) President and CEO Kathleen Jaeger today released the following statement regarding the Food and Drug Administration’s update on their efforts to improve the generic drug approval process:
“While we all share the goal of increasing efficiency in the generic approval system, another initiative in name only simply will not get the job done. What consumers need is for the FDA to address the core fundamental issues that are blocking timely consumer access to affordable generics. These core issues have been around for more than a decade and include the citizen petition process, scientific consults, enhanced communication, more inspection resources, accountability and structure of the Office of Generic Drug Program.
“For years, the Agency has tinkered around the edges with programs and initiatives designed to increase efficiency but have proven to yield little in the way of significant results. There are serious legislative and regulatory issues that must be addressed to yield a true increase in the number of affordable generics brought to market. The generic industry stands ready to work with the Agency in tackling these issues to increase consumer access. That’s why we have entered into good faith efforts with the FDA to create a meaningful user fee program that truly results in timely generic access.
“A significant investment in the generic approval process must ensure that the investment produces a meaningful program with measurable results. A successful user fee program must include robust performance measures; certainty in the review and approval process, including an Agency commitment of resources and recruitment and retention of reviewers; and the closure of barriers to access. If we do not address these long-existing, core fundamental issues, we will simply be throwing money down the drain and be doing little to help consumers get the affordable medicines they need.â€
GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic drug industry. Generics represent 63% of the total prescriptions dispensed in the United States, but only 20% of all dollars spent on prescription drugs.