A U.S. House panel yesterday advanced the Lower Chamber’s version of the bill to reauthorize the user fee deal between the medical device and drug industries and the FDA.
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.
Yesterday 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.
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.
But the Trump administration wants to make big changes to the user fee arrangement. Last month Health & Human Services secretary Dr. Tom Price penned a letter to Sen. Patty Murray (D-Wash.) asking the Senate HELP committee to consider increasing user fees and slashing the agency’s budget.
“To ensure the FDA has the critical resources needed to keep pace with this field, the President’s budget blueprint proposes to increase and restructure the medical product user fee programs at FDA to be 100% user fee supported programs, with no funding triggers that require budget authority financing,” Price wrote.
The medical device lobby was quick to praise the House HELP committee’s markup version of the bill.
“We are pleased that the legislation now includes language to streamline the review process for medical device accessories and thank the co-sponsors of the bipartisan bill (HR. 2144) – Reps. Mimi Walters (R-Calif.) and Ann Kuster (D-N.H.) – for their leadership on this issue,” AdvaMed president & CEO Scott Whitaker said in prepared remarks. “The negotiated agreement between FDA and industry to reauthorize MDUFA will improve the efficiency, predictability and transparency of the agency’s review processes while providing significant additional resources to FDA. This agreement is beneficial to patients, FDA and American innovation, and we urge the full House and Senate to vote on the FDA Reauthorization Act of 2017 as soon as possible. A failure to act would have a negative impact on our industry’s ability to bring new, innovative treatments, diagnostics and cures to patients.”
“MDMA thanks Chairman Walden and Ranking Member Pallone for their leadership and bipartisan work to strengthen the environment for medical technology innovation. MDUFA reauthorization will establish more predictability and transparency in the regulatory pathways, which will lead to improved access to the cures and therapies of tomorrow,” added Mark Leahey, president &CEO of the Medical Device Manufacturers Assoc. “MDMA will continue to work with Congress to ensure that the user fee program provides a framework where the medical technology ecosystem can answer the pressing needs that face the health care system.”