Full House Passes User Fee Reauthorization Package Including MDUFA

The House passed by voice vote its version of the FDA user fee reauthorization package Wednesday, which includes an updated version of MDUFA expected to bring in $183 million in fiscal 2018.

The reauthorization package, H.R. 2430, saw strong, bipartisan support on the House floor leading up to its passage. The Senate’s version of the user fee bill is currently awaiting a vote. Afterwards, both houses must reconcile any differences between their texts before sending the bill for the president’s signature. In early June, the House Energy & Commerce Committee unanimously voted to advance the user fee package to the floor.

The next generation of user fees is expected to bring in a total of $1.42 billion in fiscal 2018, including a 45.2 percent increase over the $126 million expected from MDUFA this fiscal year.

FDA Commissioner Scott Gottlieb said he was grateful for the House’s passage of the bill and specifically thanked the leaders of the House Energy and Commerce Committee, Reps. Greg Walden (R-Ore.) and Frank Pallone (D-N.J.).

The Senate’s version is expected to be delayed until after movement on Republicans’ efforts to repeal the Affordable Care Act, which is anticipated over the next two weeks.

Last week, Senate Majority Leader Mitch McConnell (R-Ky.) delayed the start of the Senate’s August recess period by two weeks, to provide extra time to complete the work. Senate HELP committee chairman Lamar Alexander (R-Tenn.) said he is urging his colleagues to pass the bill as soon as possible.

But Sen. Ron Johnson (R-Wis.), chairman of the Senate homeland security committee, has threatened to slow passage of the user fee bill unless it contains language on “right to try” measures, which can prohibit the FDA from considering adverse event reports from investigational drugs administered under expanded access or compassionate use requests. Johnson has supported multiple pieces of right-to-try legislation over the past year.

In a statement, the White House reiterated its position that the pharmaceutical industry should finance 100 percent of the FDA’s premarket review, eliminating the need for taxpayer dollars. However, leaders in Congress said the Trump administration’s requests came “too late” as the amounts in the must-pass bill had been negotiated between the FDA and industry over the past two years.

If the agreements are not reauthorized by Aug. 1, 60 days before the current agreements expire at the end of September, the FDA will be required to begin sending layoff notices to more than 5,000 employees, potentially crippling the agency’s ability to review applications and complete inspections.

The text of H.R. 2430, the FDA Reauthorization Act of 2017, is available here: www.fdanews.com/07-12-17-HR2430.pdf. — Conor Hale