FDA, Politics

Facing a critical August deadline, House passes bill to reauthorize FDA user fee programs

In a moment of bipartisanship, the US House of Representatives on Wednesday passed a bill via voice vote to reauthorize the prescription drug, generic drug, medical device and biosimilar user fee programs through 2022.

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 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 Wednesday that it’s now time for the full Senate to consider these bipartisan user fee agreements.

However, Sen. Ron Johnson (R-WI) also said Wednesday 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 Tuesday 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.


First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email news@raps.org for more information.


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