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WASHINGTON — The generic drug industry’s main lobby in Washington is hoping to head off cuts to the Food and Drug Administration’s Office of Generic Drugs, which it said could have a “devastating impact” on those who rely on generics.
Republicans in Congress have sought to reduce government spending by making large cuts to various domestic programs and agencies, including the FDA, which critics of the plan said could jeopardize food and drug safety.
In a letter to Republican House speaker John Boehner, Democratic Senate majority leader Harry Reid, and Office of Management and Budget director Jack Lew, the Generic Pharmaceutical Association wrote that the OGD has a backlog of more than 2,000 generic drug applications, including up to 365 first-to-file applications — a backlog that results in consumers and the government having to pay more than $200 for branded drugs because the generic versions remain unavailable.
“While we understand the difficult budget environment in which Congress is operating, the timely approval of additional generics would generate federal savings that far exceed the cost of fully funding the generic drug program,” the GPhA said.
In other news, the GPhA said Monday that VP regulatory sciences Gordon Johnston would resign and serve as senior adviser for regulatory sciences starting in April. Johnston took the VP regulatory sciences position in 2003. He has worked in the drug industry for more than 25 years and retired from the FDA in 1999 to serve as an industry consultant.
“Gordon’s commitment and contributions to the generic pharmaceutical industry over the years cannot be overstated,” GPhA chairman and Watson Pharmaceuticals president and CEO Paul Bisaro said. “He has helped increase communication and interaction with the FDA, implemented many programs that have helped our association play a critical role in quality and has been instrumental in preparing [the] GPhA to participate in the upcoming generic user fee negotiations. It’s impossible to adequately express our thanks for his tireless support of the generic industry and his outstanding service — not only for the association but also during the years he served in the FDA Office of Generic Drugs.”