GPhA criticizes FDA for GDUFA delays

Ralph Neas, president and CEO of the Generic Pharmaceutical Association, issued a statement last month criticizing the FDA at the organization’s public meeting on the Generic Drug User Free Act.

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“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,” Neas said.



With a generic drug application backlog of 4,000 and counting, the average time for reviewing drug applications is only increasing, Neas noted. The median review time has steadily increased from 30 months when GDUFA began in 2011. From fiscal year 2012 to fiscal year 2015, it rose to 31, 36, 42, and 48 months, respectively.



These delays “contribute significantly” to rising healthcare costs and affect millions of patients’ access to pharmaceuticals, he said. Industry experts estimate that the U.S. healthcare system lost more than $3 billion in savings due to first generic approval delays over the last year and a half, according to the group.



In light of the lag, Neas said it was “especially confounding” that the FDA still has $277 million in unused funds from the generic industry, pointing out that these funds “could be applied to site inspections or approvals.”