Omnibus bill would restore FDA user fees; AdvaMed, MDMA applaud

Following the release of the federal government's fiscal year 2014 omnibus appropriations legislation on Monday, medical device industry professionals issued statements lauding the government's decision to restore lost user fees.

The legislation would restore $85 million in industry-provided user fees. It also increased the FDA's budget to $91 million above presequestration funding levels, according to a statement released by the Advanced Medical Technology Association (AdvaMed). The government sequester in 2013 moved approximately $85 million in medical device and pharmaceutical user fees away from the FDA, triggering industry complaints and a bipartisan congressional response. The industry pays the user fees, which help facilitate the regulatory process for drugs and devices. Withholding the fees risked decreasing agency services and extending wait times for new studies and approvals.

"We have long maintained that user fees paid by industry to FDA should not be treated the same way as taxpayer appropriated dollars," said Stephen Ubl, CEO of AdvaMed, in a statement. "User fees are part of an agreement between industry, FDA and Congress under which industry agrees to supplement FDA's appropriated budget, and the agency agrees to performance commitments designed to increase the efficiency and predictability of the review process. Restoring these user fee funds upholds that agreement."

Mark Leahey, CEO of the Medical Device Manufacturers Association (MDMA), also applauded Congress's bipartisan efforts during the legislative process.

"The milestones that were negotiated as a part of MDUFA reauthorization are an important component to securing America's leadership in medical technology innovation, and this legislation reinforces Congress' support of this goal," he said in a statement.

- read AdvaMed's release
- get MDMA's statement

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