Officials at the FDA say they expect the backlog of generic drug applications--now at about 800--is likely to grow this year with a record number of fresh requests. Gary Buehler, director of the FDA's Office of Generic Drugs, says that he doesn't expect to be given any added money to hire more staffers--a needed change if the agency is ever to deal with the backlog. The growing pile of applications comes at a time the government has been urging widespread use of generics as a way to rein in healthcare inflation. CMS is looking to generics to contain the costs of the new drug benefit.
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