US generic drugmakers note shortfalls in FDA implementation of GDUFA

In a statement by Ralph Neas, president and chief executive of the US trade group the Generic Pharmaceutical Association (GPhA), he welcomed the opportunity that has been provided to discuss strengthening the Food and Drug Administration’s 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, said Mr Neas, adding: “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.”

Generic application backlog more than 4,000 and growing