Rep. Leonard Lance (R-N.J.) launched an effort to stop the sequestering of FDA user fees on Wednesday that has gained bipartisan support from 33 legislators.
The Office of Management and Budget recently ruled that user fees, which are used by the FDA for human drug review and other purposes, would be subject to budget sequestration. The FDA collected approximately $85 million in user fees in 2013.
Lance authored a letter to top appropriators in Congress on Wednesday that calls for an omnibus legislative package to reverse the decision.
“…The user fees are 100 percent industry paid and (are) targeted specifically for the approval of safe and effective drugs and devices,” Lance, a member of the House Energy and Commerce Committee Subcommittee on Health, said. “This decision has prevented the FDA from meeting its congressionally-mandated responsibilities while putting patient safety at risk.”
Opponents of the OMB’s decision argue that user fees, by law, cannot be diverted to the general treasury to reduce the deficit.
“Correcting this decision will help ensure that millions of Americans will continue to benefit from medicines and medical devices that are safe and effective,” Lance said.
A legislative effort to return the user fees to the FDA, the FDA Safety Over Sequestration Act, has been backed by a number of national healthcare organizations and advocacy groups.
“There is great bipartisan support to ensure that these fees be returned to their intended purpose,” Lance said.