Sponsor
Kevin Mullin
Representative · D-CA
Representative · D-CA
The bill keeps drug and device applications moving through brief government funding lapses—helping speed patient access and giving industry/FDA clearer procedures—while risking post‑shutdown backlogs and imposing timing and financial burdens that could particularly hurt smaller firms.
Patients (including those with chronic conditions), hospitals, and drug/device developers can submit complete applications during federal funding lapses and receive a 7‑day fee-payment grace period, reducing the chance that reviews are blocked and helping speed patient access to new therapies.
Provides regulatory clarity to FDA and industry about procedures during funding lapses, which can reduce administrative confusion and help limit backlog once funding resumes.
Maintains continuity of the approval pipeline during short funding gaps so developers can keep programs on schedule, supporting steady progress of medical product development.
If applicants miss the 7‑day fee-extension deadline, their applications will be deemed not accepted, which can restart review timelines and delay approvals for patients and providers.
Manufacturers—especially small firms—face administrative and cash‑flow pressure to ensure immediate fee payment after a lapse, potentially disadvantaging smaller companies and increasing costs.
Allowing filings during lapses may incentivize submission when review staff are unavailable, creating a temporary queue that shifts workload to after reopening and could prolong overall review times.
Based on analysis of 2 sections of legislative text.
Allows FDA to accept otherwise-complete drug and device submissions missing only the review fee during funding lapses and extends fee deadline 7 days after the lapse ends.
Official title: To amend the Federal Food, Drug, and Cosmetic Act to establish special rules to provide for continued review of human drug and device submissions during a lapse of appropriations, and for other purposes.
Introduced July 9, 2026 by Kevin Mullin · Last progress July 9, 2026
Allows the FDA to accept otherwise-complete human drug and device submissions that lack only the statutory review fee during a lapse in appropriations, and gives applicants a 7-day window after the lapse ends to pay the fee. If the fee is not paid within that 7-day extension, the submission is treated as not accepted and the FDA cannot clear, authorize, or approve the product until payment is received. This change is procedural and narrowly targeted at keeping regulatory review processes moving when a government shutdown temporarily prevents fee payment, while preserving the requirement that fees be paid for acceptance and final action.