The Senate voted to pass the FDA device and drug industry user fee bill by a 96-1 margin Thursday afternoon, a move praised by industry reps.
Approval fees for devicemakers would more than double if the new agreement is signed, reaching an estimated $609 million by the time it expires in 2017. However, the industry was able to avoid some changes advocated by consumer groups, including one that would require devicemakers to prove they've fixed design flaws before marketing a product based on one previously recalled.
AdvaMed, the device industry's lobby, hailed the vote, saying it's good for the agency, the industry and patients. "Through a combination of groundbreaking accountability and transparency measures and enhanced FDA resources, the user fee agreement has the potential to increase the predictability, consistency and efficiency of FDA's decision-making, while maintaining the agency's stringent product approval standards," AdvaMed President and CEO Stephen Ubl said.
But advocacy groups that wanted stricter requirements are not as enthusiastic. Lisa Swirsky, a Consumers Union policy analyst, told Politico that she was "deeply disappointed" with the omission of harsher premarket standards, but the passed bill is better than it could have been. "If you look back at what we saw in the House in December, you know this could have been a lot worse," she said. "I would say it's bittersweet, but mostly bitter."
The House is expected to vote on its very similar version of the bill Wednesday, Politico reported, and lawmakers have said they plan to get a final version onto President Barack Obama's desk by July.
- read the Politico story
- check out AdvaMed's statement