FDA generic user fees moving closer to reality

ROCKVILLE, Md. — A backlog of more than 2,000 drug entities and devices is awaiting approval. That’s the situation facing the Food and Drug Administration and the generic pharmaceutical industry—and it’s the chief impetus behind the FDA’s push to impose user fees on generic drug makers seeking the agency’s review and approval for their brand-equivalent medicines.

Call it pay to play. FDA commissioner Margaret Hamburg has told the generic industry, in no uncertain terms, that the massive logjam at the agency’s Office of Generic Drugs in the review and approval of abbreviated new drug applications for new me-too medicines has grown steadily worse as budget cuts have taken their toll and applications from generic manufacturers continue to pile up. The situation isn’t likely to get better, she warned, without the additional funds that user fees would bring to the agency.

Such a user-fee model could mimic the pattern established by the Prescription Drug User Fee Act established by Congress for the branded drug industry. “An effective user fee program negotiated between FDA and industry—a model that has seen major successes with other FDA-regulated items, including innovator prescription drugs, medical devices, animal drugs and generic animal drugs, to name a few—would reduce review times and make funding more flexible,” Hamburg asserted at a mid-September hearing by the agency to gather stakeholder input on the development of a generic drug user-fee program. “The fact is that no one benefits from a pending application queue of 2,000-plus products.”

Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, ticked off the potential benefits a generic drug user-fee program would bring both to the industry and to public health during a recent meeting with generic industry representatives. Noting that me-too medicines now account for 75% of all prescription drugs dispensed in the United States—and they saved Americans $824 billion in the last decade—Woodcock said that “user fees with performance goals” could help transform the FDA approval process.

Among those benefits, she said, would be “faster access to products,” as well as “greater predictability of the review process” and a higher level of quality assurance. For the agency, the additional money would mean “increased and more stable funding” and “better staffing and management of the review process,” Woodcock told industry leaders.

Generic drug manufacturers generally agree with the FDA, at least in spirit. Summing up the industry’s position, the Generic Pharmaceutical Association noted, “the generic industry has stated its willingness to work with the FDA to create an effective and meaningful user-fee program to provide more resources and more certainty in getting affordable generics to consumers.”

However, said the GPhA, “to make the user-fee program work, [the] FDA must address core fundamental issues that are blocking timely access to generic medicines. These core issues have been around for more than a decade—the citizen petition process, scientific consults, enhanced communication, more inspection resources and the accountability and structure of the Office of Generic Drugs.”

Thus, the GPhA has put itself on record as endorsing the establishment of user fees, with some very big conditions. Gordon Johnston, the group’s VP regulatory science, laid out those conditions during the FDA’s public hearing on Sept. 17. “[The] GPhA is supportive of user fees based on predetermined performance goals and metrics,” Johnston told the agency. However, he said, the generic industry wants some things in return.

Among them: a “substantial” increase in resources for the FDA’s Office of Generic Drugs in order to speed up the lengthy review process. “Generic drug manufacturers are acutely aware of the need to get much-needed additional resources to the FDA and the [OGD] to help handle the work associated with the review and approval of generic applications,” Johnston said.

The trade group also wants “certainty in review and action timelines,” Johnston asserted, as well as “increased opportunities for communications between industry and OGD” and “phased-in performance goals over the first five years of the [user-fee] program.”

On a more basic level, the GPhA wants user fees to serve as “a supplementary source” for OGD funding, “above and beyond congressional appropriations.” Those annual budget outlays from Congress, Johnston told the agency, “remain critical to the base funding for OGD.”