The U.S. House of Representatives reaffirmed passage of the FDA user fee reauthorization act in a 387-5 roll call vote taken after a passing voice vote earlier in the day.
The nation’s lower house voted nearly unanimously to pass the measure, which was largely lauded as a victory for bipartisan amity. The recorded vote affirmed a voice vote that won ⅔ majority support earlier in the day.
"This legislation is going to save many lives," Rep. Joe Pitts (R-Penn.) said on the House floor today. "It’s going to help the U.S. continue to be the world leader for the pharmaceutical and medical device industries and mean a lot to our economy as well."
The measure had passed earlier this month through a House subcommittee with unanimous support after just 30 minutes of deliberation.
House Speaker John Boehner (R-Ohio) this morning framed the user fee bill as a measure that will create jobs, further relating the measure to ongoing efforts to strike down President Barack Obama’s landmark Affordable Care Act, Healthwatch reported.
"Unfortunately, our nation’s device and biopharmaceutical leadership is under threat," Boehner said. "Because of the lack of predictability, consistency, transparency and efficiency at the Food & Drug Administration, U.S. device and drugs jobs have gone overseas and foreign patients, not U.S. patients, have been the 1st to benefit from U.S. innovation."
"The legislation … includes reforms to ensure patients receive quality care and timely access to new therapies while promoting innovation and job creation," he added.
Lawmakers on both sides of the aisle continued to commend the FDA user fee bill as a shining example of bipartisan amity, as had the Senate when it passed the measure in a nearly unanimous 96-1 vote last week.
Industry stakeholders and FDA representatives came to terms on a tentative version of the agreement in February, following a series of meetings in which participants hashed out the details of the fee structure, inflation adjustment rates and a waiver system for certain laboratory-developed tests.
Medical device makers largely lined up in support of the agreement, in which the FDA agreed to a number of changes in device review protocol in efforts to improve decision times and make the process more transparent and predictable.
"A strong and adequately resourced FDA is necessary to sustain public confidence and to achieve a more transparent, efficient and accountable regulatory approval process for the innovations we bring to patient care," Medtronic spokesman Steve Cragle wrote in an email to MassDevice in February. "We are pleased with the careful balance struck in this agreement and will urge the Congress to grant timely approval."