The U.S. House of Representatives agreed on a ⅔ majority voice vote today in favor of re-authorizing the bill that doubles the fees that medical device makers pay for FDA review.
The vote pushed forward the latest iteration of the Medical Device User Fee & Modernization Act, a reconciled version the original House bill and Senate bills that lawmakers approved last month.
The MDUFMA bill, which is wrapped in a larger FDA user fee measure and doubles medical device user fees from $295 million over 5 years to $595 million, will head back to the Senate for a final vote, which may happen as early as next week.
The user fee measure has sailed through both houses with bipartisan support as Congress works against an Oct. 1 deadline on what many call a "must-pass" piece of legislation.
Nonetheless, not all members of Congress have thrown their support behind MDUFMA. Sen. Bernie Sanders (I-Vt.) was the only down vote in a 96-1 decision to pass the measure, which the Senate approved May 25.
Sanders, whose amendment to cut off drug marketing exclusivity for companies charged with fraud or other violations was rejected by a 9-88 vote earlier that day, decried the FDA fee bill because it lacked sufficient controls on drug makers, he said.
The House authorized its original version of the user fee bill May 30 in a 387-5 vote, with lawmakers on both sides of the aisle commending the measure as a shining example of bipartisan amity.
MDUFMA raises the bar on fees the FDA can collect for reviewing medical devices and drugs and it does so in exchange for improvements in timing and efficiency of review, goals that Rep. Joe Pitts (R-Penn.) is keeping a close eye on.
"We’re going to follow up with real oversight on the FDA as to what they’ve committed," Pitts told MassDevice.com earlier this month. "We’re going to make sure they really deliver on what they’ve promised."
