The US House of Representatives today passed a bill to reauthorize the FDA’s medical device user fee program, alongside a prescription drug, generic drug and bio similar programs through 2022.
Newly appointed FDA commissioner Scott Gottlieb applauded the passage, saying it was a “timely reauthorization key for FDA, patients,” on Twitter after the bill passed.
“This legislation will save lives,” Rep. Greg Walden (R-OR) said on the house floor, according to a Regulatory Affairs Professionals report on the vote.
The Senate has not yet scheduled a floor debate for its version of the user fee bill, but is likely to consider them in the immediate future.
The Medical Imaging & Technology Alliance and the Medical Device Manufacturer’s Association both lauded the bill’s passage.
“MITA is encouraged by the reauthorization of MDUFA by the House and sees the user fee agreement as a win for patients, the industry and the agency. We are hopeful that the momentum of this legislation in Congress will take it over the finish line in the Senate and that it will be signed into law in short order,” MITA chair & Philips senior VP of health systems Joe Robinson said in a press release.
“MDMA applauds the overwhelming bipartisan support for MDUFA reauthorization which will provide for more predictability and transparency in the FDA’s regulatory pathways. The numerous policies contained in this legislation will empower medical technology innovators to continue delivering on the promise of a healthier tomorrow,” MDMA prez & CEO Mark Leahey said in a press release. “MDMA thanks Energy and Commerce Committee Chairman Walden and Ranking Member Pallone, as well as Health Subcommittee Chairman Burgess and Ranking Member Green for their leadership in supporting the user fee program. MDMA will continue to work with Members of Congress, the Administration and FDA to improve patient and provider access to safe and effective cures and therapies.”
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, 1st 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.
Last month the House committee approved a markup version, adding amendments on medical device servicing, the review process for imaging techniques that use contrast agents; a process for reclassifying medical device accessories; a voluntary pilot program on medical device safety and effectiveness; and a provision seeking to lower prescription drug prices. The House markup version, which now advances to the full chamber, also included technical corrections amending provisions for competitive generic therapies and a new 180-day exclusivity regime.
With the bill, medical device user fees 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 also establishes 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.
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