Will PDUFA break the FDA's generic logjam?

Is the reauthorization of the Prescription Drug User Fee Act “the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act?”

The generic drug industry’s chief spokesman and top lobbyist says so, at any rate. Ralph Neas, president and CEO of the Generic Pharmaceutical Association, called the newly enacted Food and Drug Administration Safety and Innovation Act “a remarkable achievement for patients, industry and the FDA.”

Behind Neas’ enthusiasm: The law, signed by President Barack Obama last week, could at long last break the two-and-a-half-year logjam on the review and approval of generic drug applications at the FDA and speed hundreds of pending generics to market.

The concept of charging user fees from pharmaceutical manufacturers to help fund the FDA’s review and approval process was first established in 1992, and by law Congress must vote to reauthorize the User Fee Act every five years. But this year, for the first time since PDUFA was created, the generic industry will also help foot the bill.

PDUFA will extract $299 million a year in user fees from generic drug makers for the next five years, beginning Oct. 1. Why is that good news to GPhA? The money will supplement what Congress appropriates to FDA each year, “and will enable the FDA’s Office of Generic Drugs to hire the scientific resources needed to provide timely approval of generic medicines,” the industry group predicts.

“The historic user fee legislation…will provide FDA with additional resources and ensure all participants in the U.S. generic drug system, whether U.S.-based or foreign, comply with our country's strict quality standards,” Neas said. “Very importantly, the programs will make certain that all Americans receive timely access to safe, effective and affordable generic drugs.”

GPhA predicts the new fees will dramatically shrink the average review time for most generic drug applications by nearly two years, “from more than 30 months today to 10 months by the end of the program’s fifth year.” The new version of PDUFA also will boost staff and resources at the FDA for inspections of generic makers’ manufacturing plants, as required by law before those manufacturers’ products can be approved for marketing.

Importantly, the bill signed by Obama last week “does not include an amendment — opposed by patient advocacy groups and healthcare providers alike — that would have restricted patient access to hydrocodone products,” as noted by the National Association of Chain Drug Stores. That amendment, from Sen. Joe Manchin, D-W. Va., would have made it tougher for patients to obtain common pain relief remedies containing hydrocodone — and tougher by far for pharmacies to offer them — by raising those meds from Schedule III to the more-restrictive Schedule II classification.

Long term, PDUFA could mean a stronger flow of lower-cost, higher-margin generics to retail and institutional pharmacies, which is a plus for patients and payers as well as the pharmacy operators themselves. But adding to FDA’s scientific staff, drug assay capabilities, testing facilities and other resources is expensive. Will the $299 million in annual user fees paid by generic makers make that much difference in review times? Share your thoughts by clicking on the link below.

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