GPhA’s Neas criticizes FDA for GDUFA delays

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

“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.

As the GDUFA nears its Sept. 2017 expiration date, the FDA is holding a hearing regarding re-negotiations. The GDUFA aims to provide widespread access to generic drugs and cut down on industry costs, according to the FDA’s website. It requires industry to cover user fees in order to “supplement the costs of reviewing generic drug applications and inspecting facilities.” 

GDUFA is also designed “to reduce a current backlog of pending applications, cut the average time required to review generic drug applications for safety, and increase risk-based inspections.”

But with a generic drug application backlog of 4,000 and counting, the average time for reviewing applications is only increasing. The median review time has steadily increased from 30 months when GDUFA began in 2011. From FY2012 to FY2015, it rose to 31, 36, 42, and 48 months, respectively.

These delays “contribute significantly” to rising health care costs and affect millions of patients’ access to pharmaceuticals, Neas added. 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,” Neas said.

In light of this 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.”

Neas said he hopes the 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,” he said.