- June 05, 2018
Several representatives discussed the issue of expensive medicines on the House floor Wednesday, though none of the user fee programs address the issue directly. However, speeding the review of generic drugs could lower some high-priced brand name drugs and generic drugs with no competition.
FDA Commissioner Scott Gottlieb praised the bill’s passage in the House.
The current user fee programs expire 30 September, though the US Food and Drug Administration (FDA) has said that if the reauthorization bill is not signed by President Donald Trump before 1 August, the agency will have to send out layoff notices to about 5,000 of its employees. “This legislation will save lives,” Rep. Greg Walden (R-OR) said on the House floor, noting he thinks the Senate will adopt the bill, as well.
The Senate has yet to schedule a floor debate and vote on its version of the user fee bill. Sen. Lamar Alexander (R-TN) said in July that it is now time for the full Senate to consider these bipartisan user fee agreements. However, Sen. Ron Johnson (R-WI) also said that day that he will try to delay the bill unless it includes language related to the “Right-to-Try” legislation, which undercuts FDA and has been sweeping across states. A nonpartisan report issued notes that issues with expanded access are not linked to FDA regulations.
In total, the Congressional Budget Office says it expects FDA to collect roughly $9 billion in fees — $8 billion for drugs and $1 billion for devices — between 2018 and 2022, based on the fee level set in the Senate bill.
HR 2430: FDA Reauthorization Act of 2017
REFERENCE: RAPS Regulatory Focus; 12 JUL 2017; Zachary Brennan