Medicines administrator calls for collaboration with generic drugmakers on fee collection

{mosads}The user fee agreement’s goal is to reduce the review process from the current 30 months to 10 months. Hamburg explained that under-collecting fees would weaken the agency’s ability to reduce its backlog, while over-collecting would penalize drugmakers without helping the FDA because the extra revenue would have to be transferred to the government’s general fund. 

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.