(Reuters) - Generic drugmakers would pay the U.S. government $38 million to help speed reviews of their medicines under President Obama's fiscal 2011 budget plan. The Obama administration will ask Congress to pass legislation allowing the Food and Drug Administration to collect the fees. The money would be used to “improve review times and reduce the current backlog of applications,” budget documents said.
Congress will weigh Obama's budget plan as it drafts the federal budget for fiscal 2011, which starts October 1. His proposal for fiscal 2010 also proposed fees from generic drugmakers, but the measure did not make it through Congress. Generic drugmakers have supported the idea of paying fees if they are coupled with improvements in the FDA review process.
Some feel the fee program could be a positive if it ends tactics used to block generic drug approvals or directs money to clearing products held up by those tactics. President Obama also proposed a $2 million increase in taxpayer funding for the FDA's generic drug reviews. The agency's total budget would increase by 23 percent from fiscal 2010 to $4 billion.
New funding would be used in part to help the FDA prepare for future applications to sell generic copies of biotechnology medicines, health officials said. Congress is weighing creation of a path for companies to apply for FDA approval of generic biotech medicines as part of the stalled healthcare reform legislation. According to budget documents, the agency also plans to expand post-market safety surveillance of medical products.