WASHINGTON (Reuters) - President Barack Obama on Monday proposed fees on generic drugmakers to help reduce review times for the cheaper copycat medicines and clear a backlog of applications.
Documents outlining Obama’s fiscal 2011 budget plan also proposed funding increases at the Food and Drug Administration “to bring more safe, effective and lower cost generic drugs and generic biologics to market” and to “expand postmarket safety surveillance of medical products.”
Biotech medicines, or biologics, are made from living things and are more complicated to produce than traditional-chemical based drugs. Congress has been considering measures to provide a legal path for FDA approval of generic biologics as part of the stalled healthcare reform legislation.
Congress will consider Obama’s budget plan as it drafts the federal budget for fiscal 2011, which starts October 1.
Generic drugmakers have supported the idea of paying fees in exchange for improving the FDA review process for their medicines.
Reporting by Lisa Richwine, editing by Gerald E. McCormick and Lisa Von Ahn
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