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The House returns from its week-long Memorial Day recess Tuesday with plans to pass a bill (H.R. 7667) to reauthorize user fees the Food and Drug Administration negotiates with regulated industries.
The bill — which House leaders plan to push through under suspension of the rules, requiring a two-thirds majority — would reauthorize user fees for prescription drugs, medical devices, generic drugs, and biosimilar products from fiscal 2023 through 2027. The current authorization is set to expire Sept. 30.
The FDA negotiates user fees and performance goals with industry and submits its recommendations to Congress for reauthorization on a five-year cycle.
The agency separately receives an appropriation from Congress annually. The user fees are intended to supplement that appropriation, and current law prevents collection of fees if certain funding levels aren’t appropriated.
In addition to the user fee reauthorizations, the measure would address clinical trial diversity, accelerated approval pathways, generic drug approvals, and other FDA processes.
The modified bill slated for floor action would deposit $450 million into the Medicaid Improvement Fund and includes new language on centers of excellence in manufacturing, among other changes.
- On prescription drug fees, the measure would set a base fee amount for fiscal 2023 of $1.15 billion. Amounts would be adjusted each year for inflation, capacity planning, operating reserves, and other factors, including a new adjustment for strategic hiring and retention.
- Fees for medical device manufacturers would be reauthorized based on the agreement between FDA and industry. The measure would set a base total revenue amount for fiscal 2023 of $312.6 million, increasing to $418.3 million by fiscal 2027 and adjusted for inflation.
- Total revenue from generic drug fees would be set at $582.5 million for fiscal 2023. Fee revenue for fiscal 2024 through 2027 would be adjusted for inflation, capacity planning, and operating reserves. The bill would modify the percentage of fees derived from: Active pharmaceutical ingredient facilities to 6% from 7%. The generic drug applicant program to 36% from 35%.
In the Senate, the Senate Health, Education, Labor, and Pensions Committee will hold a markup Wednesday on its own measure S. 4348 to reauthorize user fees for prescription drugs, medical devices, generic drugs and biosimilar biological products.
Also on Lawmakers’ Radars
Hearings This Week:
- The House Veterans’ Affairs Committee holds a Wednesday hearing on a slate of legislation related to veterans’ health care.
- Click here for a list of the week’s hearings and markups.
Formula Bill Would Expand Inspection Oversight: The FDA would need to inspect infant formula manufacturing facilities at least every six months under a bill that aims to hold the agency accountable for its actions leading up to the nationwide shortage. The measure, obtained by Bloomberg Law, would give the Food and Drug Administration expanded authority to conduct unannounced inspections on formula plants and require manufacturers to alert the FDA once they become aware of situations that could lead to shortages. Read more from Celine Castronuovo.
- Meanwhile, Abbott restarted infant formula production at a facility in Michigan, months after its closure on health grounds exacerbated a national shortage of food for very young children. The company met the Food and Drug Administration’s initial requirements under a pact reached last month, Abbott said in a blog post Saturday. A spokesperson also confirmed that the plant — one of four facilities in the US — is restarting baby formula production. Read more from Amelia Pollard and Susanne Barton.
Hunger ‘Cliff’ Looms as Pandemic School-Lunch Aid Is Running Out: Schools and child-feeding sites are bracing for rising costs and supply disruptions as federal meal subsidies run out in weeks.
The food assistance, in the form of Agriculture Department waivers authorized since the start of the Covid-19 pandemic, allows schools and child-feeding programs to distribute meals free to kids regardless of family income, and receive federal reimbursement. The waivers expire June 30—barring congressional action to renew them. Maeve Sheehey has the story.
What Else to Know Today
FDA Medical Device Deadlines Return to Pre-Covid Norms: The Food and Drug Administration is pulling the plug on a pandemic-era program that cut medical device manufacturers a break on filing deadlines, describing the move as a way to bolster the rollout of life-saving technologies amid changing Covid-19 conditions. Medical device makers will no longer get a grace period for responding to FDA deficiency letters regarding Humanitarian Device Exemption and Premarket Approval applications. Read more from Ian Lopez.
Juul, Altria Fail to Unseat Vapers’ Experts From Trial: Scientists and doctors may largely express their expert opinions in testimony against Juul Labs, Altria, and individual Juul officials in litigation over alleged e-cigarette marketing to youth, including in an upcoming test trial, a federal court in California ruled. The companies and directors may unleash their criticisms in cross-examination of the experts, Judge William H. Orrick III said Thursday for the US District Court for the Northern District of California. Read more from Martina Barash.
EPA Says PFAS Health Data Rule Imminent: Orders for PFAS manufacturers to generate new data to help the EPA understand how these chemicals move through the environment and affect people and wildlife will be issued the week of June 6, a senior agency chemical official said Friday. The Environmental Protection Agency will issue orders “very early next week,” Denise Keehner, director of the agency’s Office of Pollution Prevention and Toxics (OPPT), said at an American Bar Association meeting where she and other agency officials discussed timelines for planned regulatory and other chemical policy activities. Read more from Pat Rizzuto.
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- Amylyx Rallies After Drug Review Delay Reignites Approval Hope
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