United States House of Representatives Passes PDUFA

On Wednesday, July 12, 2017, the United States House of Representatives passed a bill via voice vote to reauthorize the prescription drug, generic drug, medical device and biosimilar user fee programs through 2022. The current user fee programs expire September 30th, though the United States Food and Drug Administration (FDA) has said that if the reauthorization bill is not signed by President Donald Trump before August 1st, the FDA will be forced to send out layoff notices to about 5,000 employees. “This legislation will save lives,” Representative Greg Walden said on the House floor, noting he thinks the Senate will adopt the bill, as well. In addition to reauthorizing the user fee programs, the bill contains several new directives for the FDA, including provisions requiring quicker reviews of some generic drugs and changes in how the agency will conduct medical device inspections. The FDA will also be instructed to work on expanding clinical trial criteria so more patients can be eligible for experimental medicines. The bill is expected to cut the time it takes the agency to approve new treatments. The House added more than a dozen new sections to the bill ahead of the vote, including sections aimed at curbing abuse of the orphan drug designation and policies designed to speed generic drug approvals. Most of the new elements of the House bill were added to align the chamber's legislation with the version passed out of the Senate HELP Committee. The House bill added...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs