House votes to extend medical device user fees

The FDA user fee reauthorization bill continued its quick trip through Congress on Wednesday, as the House approved  doubling the price devicemakers will pay for approvals and clearances. The measure will head back to the Senate as early as next week, according to Politico.

The 5-year agreement cleared the House by voice vote, and, if signed, the bill would raise device companies' total fees from $295 million to $595 million. The bill passed Wednesday is a reconciled version of the House and Senate versions approved earlier this month, and the pending Senate vote will likely be Congress' last word on the issue.

Despite the hefty price increase, the device industry has lent its support to the new user fees. The greater cost comes with the promise of a more predictable, reliable, efficient and expeditious FDA approval process, and Stephen Ubl, CEO of AdvaMed, said the bill's so-far painless path is a sign that industry and government can work together.

Legislators, too, are getting in on the self-congratulation. The bill has enjoyed bipartisan support, and Rep. Joe Barton (R-TX), said it's a welcome development in an often strife-ridden Congress. "When the American public asks this Congress why we can't work together, we should hold this bill up as Exhibit A that we can," Barton told Politico.

Less enthusiastic, however, are some consumer advocacy groups. The bill includes none of the stricter premarket standards supported by outfits like Consumers Union, and calls for tightening the 510(k) process went largely ignored by Congress.

- read the Politico story
- read AdvaMed's statement

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