House handily passes reauthorization of user-fee program

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The U.S. House of Representatives has reauthorized the Medical Device User Fee & Modernization Act (MDUFMA), and done so with a resoundingly bipartisan 387 to five vote.

The development came the evening of May 30, six days after the Senate passed similar legislation by a 96 to one margin. The two chambers will now try to hammer out a single bill to present to the President, presumably aiming to complete the reconciliation process before the current five-year fee program expires on Sept. 30.

MDUFMA calls for industry to double the user fees it pays FDA, to nearly $600 million, in exchange for faster and more consistent reviews. FDA and industry representatives agreed to the arrangement last winter.

The final House bill was amended from an iteration approved earlier in May by the House Energy & Commerce (E &C) Committee. The final version addressed a Congressional Budget Office estimate showing that E &C’s version would increase the federal deficit by nearly $250 million over a decade. Tweaks made following the estimate render the bill closer to the Senate’s May 24 legislation and stand to reduce the deficit by almost $370 million over the same period, according to The Hill.

Industry respresentative Stephen J. Ubl, head of the Advanced Medical Technology Association (AdvaMed), wasted no time expressing his delight with the outcome in the House.

“This potentially game-changing user fee agreement includes provisions that will strengthen accountability measures [and] provide additional FDA resources,” Ubl said in prepared remarks. “And under the agreement, the FDA is presented with an opportunity to improve its predictability, consistency and efficiency, while continuing to adhere to its high standard for product approval.”

Among those cheering the news from the provider side was William Zoghbi, MD, president of the American College of Cardiology: “Innovative treatments have played a pivotal role in reducing deaths due to cardiovascular disease in recent decades. It is important to support a system that encourages the development of new medications and devices,” he said in a written statement. “The agreement is excellent for patient health, the future of medical science and continued advances in the field of cardiology.”

Michigan Republican Fred Upton, author of the broader legislation containing the user-fee agreement, the FDA Reform Act of 2012, cited the bipartisan cooperation that led to its passing. “I applaud House Democrats and Republicans for coming together on this issue to get the job done—this is how policymaking should work,” he said.