Tight Timeline to Reauthorize FDA User Fee Programs Before FDA Begins Layoffs

Posted 29 June 2017 By Zachary Brennan

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The US Senate and House of Representatives have given themselves a little more than 10 working days to finish a bill to reauthorize the US Food and Drug Administration (FDA) drug, generic drug, medical device and biosimilar user fee programs and get it signed by President Donald Trump before thousands of FDA employees will receive layoff notices.

In the Senate, the bill advanced through the Health, Education, Labor & Pensions Committee almost unanimously in May. The House Energy and Commerce committee also advanced a similar bill earlier this month, setting up what looked like a bipartisan win to fully fund FDA and ensure medical products are approved on a consistent timeline agreed to by both FDA and industry.

But when asked if there were still plans to get the bill finished before Congress’ August recess, David Popp, communications director for Senate Majority Leader Mitch McConnell (R-KY), told Focus that he does not have any guidance on the timing of the bill.

According to the Congressional calendar for 2017, both the House and Senate are recessing next week for July 4, and then the Senate is in session for 15 days before the month-long August recess, while the House is in session for 13 days before recess. On top of the limited time before recess, Congress has been engaged in a heated debate over the repeal and replacement of the Affordable Care Act.

And though technically the current five-year FDA user fee agreements do not expire until 30 September, a press release from Sen. Lamar Alexander (R-TN) noted: “If the agreements are not reauthorized before the August work period, the agency will be forced to send layoff notices to more than 5,000 FDA employees.”

What still needs to get done?

Both bills still must be scheduled for floor debates, in addition to votes and the forging of an agreement to reconcile the differences between the two bills.

Amendments adopted by the House committee include proposals for risk-based classification for medical device accessories, easing requirements for medical imaging devices and contrast agents, servicing and maintenance of medical devices, a pilot project for active surveillance of medical devices and new labeling requirements for over-the-counter hearing aids.

On the Senate side, two additional amendments were added, one from Sens. Orrin Hatch (R-UT), Michael Bennet (D-CO), Richard Burr (R-NC), and Bob Casey (D-PA) on expanded access to drugs and one from Sens. Al Franken (D-MN) and Susan Collins (R-ME) on generic drugs and competition.

After reconciling those differences, Trump, who had previously called to vastly increase the amount of user fees under the deal, would have to sign the bill. If Trump vetoes the bill, the House and Senate may have enough bipartisan support to override the veto, though that largely depends on what the final bill looks like.

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

Tags: FDARA, user fee reauthorization, FDA user fees, user fee deals

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