Aiming to avoid laying off thousands of workers at the FDA, legislators on Capitol Hill last week floated a bill to reauthorize the user fee agreement between industry and the federal safety watchdog.
Medical device and drug companies pay user fees to have the FDA review their products. The last Medical Device User Fee Act in 2012 doubled user fees from $295 million over 5 years to $595 million, in exchange for performance goals set for the FDA.
Although the parties hammered out the 4th MDUFA iteration last August, earlier this year the Trump administration proposed doubling the fees to $2 billion for calendar 2018. In return, the Trump budget would contain “a package of administrative actions designed to achieve regulatory efficiency and speed the development of safe and effective medical products.”
The bill, floated April 14 by the House Energy, Labor & Pensions and the Senate Energy & Commerce committees, would increase to total user fee program to $1.17 billion for fiscal 2017, which begins Oct. 1, adding about $400 million.
Medical device user fees would rise from $130.2 million in fiscal 2017 to $183 million in fiscal 2018, topping out in the final year of the deal at $213.7 million for fiscal 2022, according to a summary. The bill would establish a category for de novo applications, enabling a user fee for those product reviews, and create a pilot program across 5 device types to audit, certify and police medical device testing labs.
“This agreement is good for industry. It is good for FDA. And most of all, it is good for patients. We urge this committee and the Congress as a whole to act promptly to reauthorize the user fee program and enact this agreement into law. Failure to act would not only jeopardize the critical improvements made by the new agreement but would have a devastating impact on our industry’s ability to bring innovative diagnostics, treatments and cures to patients,” AdvaMed president & CEO Scott Whitaker said during testimony before the House panel earlier this month.
“The ground-breaking process improvements that were built into the MDUFA III agreement, and the oversight done by this committee, have led to improvements in FDA’s regulation of medical devices. FDA has brought down the total time it takes to receive a decision from FDA on a product submission, while still maintaining the strongest standards for evaluating safety and effectiveness. Opportunities for engagement between applicants and FDA throughout the device review process have increased, leading to fewer misunderstandings and false starts, and a better understanding of FDA data needs. As a result, the consistency and predictability of the FDA review process has shown improvement,” Whitaker said.