New Provisions in Senate User Fee Bill as Vote Scheduled
The Senate is scheduled to take up the Food and Drug Administration (FDA) Safety and Innovation Act (FDASIA) on Thursday, 17 May, and numerous sources report new provisions have entered into the latest iteration of the legislation.
The bill, which contains several pieces of related legislation, is intended to reauthorize industry-funded user fees for pharmaceutical and medical device products and make a host of changes to FDA's regulatory processes.
Both Politico and The Hill report the bill, co-sponsored by Sens. Tom Harkin (D-IA) and Mike Enzi (R-WY), is set to be voted on after 9:30 AM by the full Senate after incorporating some minor changes.
The bill "contains a few negotiated changes since the Health, Education, Labor and Pensions Committee marked up an earlier version last month, including language regarding FDA's regulation of mobile medical apps," writes Politico. Those changes include provisions introduced by Harkin requiring FDA to seek patient input in product development and regulatory discussions, reports BioCentury.
Politico notes the Senate version of the legislation will likely incorporate additional provisions, including a track-and-trace provision for medical devices, before it is brought to the Senate floor for a vote.
The Pink Sheet reports new provisions in the bill would also require FDA to "consider foreign clinical trial data when making approval decisions," particularly those trials conducted in the European Union.
Senate Majority Leader Harry Reid told Politico he hopes to have the bill passed unanimously without needing to file cloture, which would open the bill to filibuster attempts and delays.
Read more:
The Hill's Floor Action Blog - Thursday: 142 NDAA amendments in the House, FDA bill in the Senate
BioCentury - Harkin adds patient input requirement to PDUFA bill