The medical device and pharmaceutical industry user fee bill should be on its way to the White House for President Obama's signature by the end of Tuesday, capping one of the quickest congressional legislative actions in recent memory.
On Monday, the U.S. Senate voted 89-3 to close debate on the conference committee version of the bill, MassDevice reports, which will raise device companies' total fees from $295 million to $595 million over 5 years. After a few final procedural things (the final House vote and any amendments, and a final Senate vote to accept the amended version) then the next step is President's desk. A final Senate vote was expected Tuesday afternoon (basically a formality).
Less then a week ago, the House cast an initial vote approving the conference committee bill. Both arms of Congress passed their initial, separate bills just last month.
Industry leaders have generally supported the bill, which calls for higher fees in return for an FDA approval process designed to become quicker as well as more efficient, reliable and transparent. Supporters, such as AdvaMed, say the changes could help boost development and approval of new device treatments and diagnostics. But consumer groups opposed the bill after unsuccessfully pushing for a tighter 510(k) process. The Consumers Union, for example, wanted devicemakers to have to prove they fixed any design flaws when they wanted to market a new device based on an earlier model that had been recalled over safety issues.
- read the MassDevice story