Generic drug backlog persists as FDA slowly clears applications
- The Food and Drug Administration continues to work through its hefty backlog of generic drug applications, Regulatory Focus reports.
- Over the past three months, the FDA has reduced the total number of abbreviated new drug applications (ANDAs) currently with the agency by 160 applications.
- However, 2,802 ANDAs remain with the FDA and another 1,000 or so are awaiting a response from industry applicants. The FDA approved or tentatively approved 198 ANDAs between January and March this year, a slightly slower pace than the previous period.
The Generic Drug User Free Act (GDUFA) of 2012 was intended to expedite ANDA approval by providing additional funding, which is collected from industry. This legislation expires in September 2017 and is currently under consideration for renewal.
Janet Woodcock, director of the Center for Drug Evaluation and Research, has said that the agency will have worked its way through the backlog by September 2017, but the Generic Pharmaceutical Association (GPhA) has expressed its concerns about the pace of the process.
Back in January, David Gaugh, senior vice president of Science and Reguloatry Affairs at GPhA, said: "Too many generic drug applications including potential first generics have been sitting with the [FDA] for many years before being picked up by a reviewer. These delays contribute significantly to rising health care costs and impact access to pharmaceuticals for millions of patients."
The heavy ANDA workload for the FDA reflects a robust generic drug industry in the U.S., with a large percentage of prescriptions filled with generics. And while the FDA appears to be working diligently to clear the backlog, the agency will likely have to commit more resources to dealing with biosimilars as more of those drugs are developed in the U.S. over the coming years.
- Regulatory Affairs Professional Society FDA Slowly Chips Away at ANDA Backlog