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Lawmakers recently found themselves in the unfamiliar territory of bipartisanship when the House of Representatives voted overwhelmingly in favor of the Food and Drug Administration Reform Act.
Approved by a 387-5 vote, the bill sets forth several policy reforms pertaining to drugs and medical devices. The legislation will increase the so-called user fees that are paid by drug and medical device companies to the FDA and should expedite the review process for these devices and improve transparency of their clearance process. Lawmakers are expected to have a final draft of the legislation by early July.
The bill – which some observers call a watered-down version of recent Senate-approved legislation – is projected to reduce the federal deficit by an estimated $370 million over the next decade, according to the Congressional Budget Office. Eyeing such savings, lawmakers from both sides of the aisle overlooked ideological differences that have often stymied the legislative progress in recent years.
“Our bipartisan reform package is the culmination of more than a year of work and negotiations between House Democrats and Republicans,” Rep. Fred Upton (R-Mich.) wrote this month in the Holland (Mich.) Sentinel.
"The FDA Reform Act contains important metrics that will hold the FDA accountable for its performance, will help provide new therapies to our nation’s children, significantly improve scientific exchange at FDA’s advisory committees and ensure transparency and public input in the development of FDA’s guidance documents,” Upton added in an Energy and Commerce Committee press release earlier this month.
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