Lawmakers attach user fees to CR, plan to revisit riders after mid-terms

Regulatory NewsRegulatory News | 27 September 2022 |  By 

Lawmakers have struck an eleventh-hour deal to renew the US Food and Drug Administration’s (FDA) user fee programs. With just four days to go before the current programs expire, Democrats conceded to Republican demands for a “clean” reauthorization package without major riders, including diagnostics reform.
On Monday night, House and Senate lawmakers agreed to a continuing resolution (CR) that would avert a government shutdown until Congress can work out a longer-term spending bill in mid-December. The bill includes reauthorization of FDA’s prescription and generic drug, biosimilar and medical device user fee programs for another five years, which means the agency will not have to lay off user-fee funded staff. (RELATED: Convergence: CDRH will continue with MDUFA V plan even with user fee delay, Regulatory Focus 15 September 2022)
“We are glad to announce an agreement to reauthorize the FDA user fee programs, which will ensure that FDA can continue its important work and will not need to send out pink slips,” said Sens. Patty Murray (D-WA) and Richard Burr (R-NC), who lead the Senate Health, Education, Labor, and Pensions (HELP) committee, in a joint statement. “However, there is more work ahead this Congress to deliver the kinds of reforms families need to see from FDA, from industry, and from our mental health and pandemic preparedness efforts.”
The continuing resolution needs 60 votes in the Senate to pass before being sent to President Joe Biden for his signature. The upper chamber is scheduled to vote later today on cloture on the CR.
While the inclusion of the user fee programs is a sigh of relief for FDA, the bill lacks many riders the agency was hoping to see passed alongside the reauthorization bill. That includes the long-anticipated Verifying Accurate Leading-edge IVCT Development (VALID) Act, which would give FDA additional authorities to regulate in vitro diagnostics (IVD), including laboratory-developed tests (LDTs).
The stripped-down version of the user fee reauthorization bill also does not include riders that would reform FDA’s accelerated approval program, as well as its oversight of cosmetics and dietary supplements. Nor does the bill include riders that would address change control plans for artificial intelligence/machine learning (AI/ML) medical devices, mandate the agency periodically update its medical device cybersecurity guidances and reduce the cost of generic drugs by easing their path to market. (RELATED: Senate HELP sends user fee reauthorization bill to floor vote, Regulatory Focus 27 September 2022)
The user fee reauthorization bill hit a snag in July when Burr introduced a clean reauthorization bill arguing the riders undermine the purpose of the user fee programs amid concerns time was running out to renew them. (RELATED: Burr introduces stripped-down user fee bill, Regulatory Focus 14 July 2022)
“The policies added to this bill endanger the development of drugs for rare diseases, imperil intellectual property rights, threaten Americans’ access to breakthrough treatments and cures, and deter private sector innovation,” he said at the time.
While Republicans may have won this legislative battle, Democrats have not given up hope on the policies set out in the now discarded riders, and plan to continue the fight to pass those reforms after the November mid-term elections.
Rep. Frank Pallone (D-NJ), chair of the House Energy and Commerce committee, argued that lawmakers in the key House and Senate committees had already agreed to overarching policy areas to attach to the user fee reauthorization bill this summer until Republicans objected to them. However, he said the fight isn’t over, and lawmakers on both sides of the aisle and in both chambers have agreed to revisit those riders later in the year.
“Unfortunately, Senate Republican leadership blocked these policy agreements from being included,” said Pallone. “All four corners committed to returning to the negotiating table ahead of the December government funding deadline to revisit these key priorities. I’m going to continue pushing to advance as much of the House-passed legislation as possible.”


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