House, Senate Still Aim to Pass FDA User Fee Reauthorization Bill Before Delayed August Recess

Posted 11 July 2017 By Zachary Brennan


The US House of Representatives on Wednesday will take up a bill to reauthorize the US Food and Drug Administration’s (FDA) prescription drug, generic drug, biosimilar and medical device user fee programs, and though the Senate has not yet scheduled a time to take up the bill, it is expected to before thousands of FDA employees are laid off.

The bipartisan House user fee bill, which sailed through the Energy & Commerce committee unanimously last month, has been amended slightly since then, though none of the changes are likely to be controversial enough to derail it.

Provisions related to pediatric drugs and devices have been added that are similar to a bipartisan bill introduced in late February.


Sen. Mitch McConnell (R-KY) on Tuesday announced that the Senate’s recess would be pushed back by two weeks, increasing the likelihood of the user fee bill’s passage before the ultimate deadline of 30 September, though perhaps not before the August deadline when FDA has to send out warnings of layoffs.

David Popp, communications director for McConnell, told Focus that he does not have any guidance or announcements on the time when a vote will take place, adding, “I would gently remind you that we are working on health care right now.”

Sen. Lamar Alexander (R-TN), meanwhile, said in a statement that he hopes the bill will get done before recess.

“We think the House bill is a very good bill, almost the same as the Senate bill so it’ll give Senator McConnell two different options for trying to do the bill before the August recess,” he said.

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Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, News, US, FDA

Tags: FDA user fees, user fee reauthorization, PDUFA, MDUFA, GDUFA, BsUFA

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