While I rarely use others’ comments in full to populate this blog, I think that Ralph Neas, President and CEO of GPhA, said all that needs to be said on the state of GDUFA and the hope for future improvements – so here is:
WASHINGTON, DC (June 15, 2015) —
“The Generic Pharmaceutical Association (GPhA) welcomes today’s opportunity to discuss strengthening the Food and Drug Administration’s (FDA) implementation of the Generic Drug User Fee Act (GDUFA). The generic drug industry funds 100% of this $1.5 billion program now at its midpoint, and it is helpful to reflect on where we stand, particularly with GDUFA re-negotiations approaching.
It is industry opinion that the FDA is falling short of meeting its commitment to GDUFA goals, resulting in decreased access for patients and billions of dollars in lost savings. However, process changes and staff expansion over the past three years have set a promising foundation for FDA action. But, the results thus far leave much room for improvement.
The generic drug application backlog is more than 4,000 and growing, according to FDA data. And, as the backlog increases, median review times for generic applications are getting longer.
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.
Given the sluggish pace of reviews and the steadily growing backlog, it is especially confounding that the FDA still has $277 million in unused funds from the generic industry that could be applied to site inspections or approvals.
These avoidable delays contribute significantly to rising health care costs and impact access to pharmaceuticals for millions of patients. In fact, industry experts estimate that the U.S. health care system lost more than $3 billion in savings due to first generic approval delays over the last year and a half.
Millions of patients, businesses, taxpayers, prescribers, dispensers and others deserve better from the FDA.
As mentioned in the September public hearing, GPhA is hopeful that FDA will improve communication between the agency and manufacturers. Without more meaningful transparent correspondence, generic manufacturers are unable to plan for the critical steps in the market entry processes.
GPhA welcomes the opportunity to continue to work with FDA to ensure that our shared commitment to core GDUFA goals —improved safety, access and transparency — is achieved as intended.”
FDA will need to demonstrate sustained improvement (some of which we are seeing in terms of an increase in approval trends) to assure the negotiation for GDUFA II move in a positive direction for the FDA, industry and the American public.