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Medicines administrator calls for collaboration with generic drugmakers on fee collection
The nation's top medicines administrator called for close collaboration between drugmakers and federal regulators to ensure the Food and Drug Administration (FDA) is able to collect the fees it needs to review generic applications.
Speaking at the Generic Pharmaceutical Association's annual meeting in Orlando, Fla., FDA Commissioner Margaret Hamburg said proposed user fees would help cut down her agency's backlog of 2,500 applications — but only if drugmakers do their part to ensure the FDA collects the $1.5 billion it's supposed to over the next five years. The time it takes to approve new generics has nearly doubled over the past few years, because the number of applications has grown at an "outstanding rate" while resources at the FDA have stagnated.
"To properly assess individual fee amounts," she said, "we'll need you to help us identify your facilities, how many you have, the type, whether they're foreign or domestic … This is really vital for us, because to collect the correct amount of user fee revenue as negotiated with the industry, FDA needs to be able to accurately predict the number of fee-paying facilities and the number of applications."
The agency transmitted its agreement with industry to Congress in January. Lawmakers introduced bipartisan legislation this month calling on generic drugmakers to pay about $1.5 billion over the next five years to help fund the federal regulators who review and approve new drugs.
Hamburg also said her agency was close to announcing a new director of the Office of Generic Drugs, which she said she had hoped to announce at the conference. The previous director, Gary Buehler, was removed from the post in March 2010 after Hamburg lamented an "unprecedented spike" in the applications backlog during a speech at the GpHA's 2010 conference.
