The U.S. House of Representatives is scheduled to vote on a bill re-authorizing the user fees medical device makers pay to have the FDA review their products.
The bill would double the user fees medical device companies pay for agency review, from $295 million over 5 years to $595 million, in exchange for the FDA meeting performance goals.
Majority leader Eric Cantor’s (R-Va.) office told The Hill that the bill is slated to hit the House floor under special rules requiring a ⅔ majority for passage. The House version was approved on a 387-5 vote in May.
The U.S. Senate is likely to have its say next week, a Senate aide told the website. The Senate passed its version on a 96-1 vote May 24. Congress is working against an Oct. 1 deadline on the must-pass legislation.
Although it enjoys broad bi-partisan support, not everyone is on board with the user fee bill. Watchdog groups such as Consumers Union, the policy advocacy arm of Consumer Reports magazine, wanted the measure to force companies to prove that new devices are free from flaws that led to recalls or safety issues in prior products that are serving as a foundation for review.
"This bill includes some important reforms that will improve the FDA’s ability to monitor medical devices on the market and to notify patients and require stricter testing when safety problems arise," Lisa McGiffert, director of Consumers union’s Safe Patient Project, said in prepared remarks. "But there is clearly more work that needs to be done to ensure that the FDA has all the tools it needs to ensure medical devices are safe and effective before they can be used on patients."
The compromise bill worked out between the House and Senate limits the FDA’s authority to reject investigational device exemption applications, according to Consumers Union, and "eliminates existing limits on the number of waivers the FDA may grant to experts with financial ties to the medical device industry."
