It's now the House's turn. U.S. House Republicans are expected to vote today on the FDA user fee bill, and Politico predicts the bill will sail through without any problems.
Meanwhile, the Consumers Union is sounding the alarm, claiming that the House bill is weaker than what the Senate passed just last week. They want the House bill to make it easier for the FDA to reclassify problematic devices so related ones are looked at more rigorously before approval. Also needed, according the group, is a time frame for imposing proposed regulations on unique device identifiers.
They criticize each version of the bill for lacking "critical patient safety protections." But the industry has supported both as keeping regulatory standards high but also making the approval process less cumbersome.
Device industry group AdvaMed lauded the Senate bill as striking a valid balance between the needs of regulators, industry and patients. Device approval fees will more than double over the life of the new agreement, reaching $609 million before it expires in 2017. He said the measure will help make the regulatory process more predictable and consistent and keep approval standards "stringent."
- read the Politico item
- here's the Consumers Union release