Getting Innovations to Patients During Shutdowns Act
- Bill Number
- H.R. 9635
- Origin Chamber
- House
- Congress
- 119th Congress, Session 2
- Status
- Introduced
- Latest Action
- 2026-07-09: Referred to the House Committee on Energy and Commerce.
- Last Updated
- 2026-07-11T14:09:55Z
AI-Generated Summary
Purpose This legislation amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to continue reviewing certain human drug and medical device applications during a lapse in federal appropriations (commonly known as a government shutdown). The goal is to prevent delays in the review process caused by temporary funding interruptions.
Key Provisions
- Human drug applications: During a lapse in appropriations, the FDA may accept a drug application or supplement that is otherwise complete except for the required user fee. The deadline for paying the fee is extended to 7 days after the lapse ends.
- Medical device submissions: A similar rule applies to premarket device applications. The FDA may accept a submission missing only the user fee and extend payment by 7 days after the lapse.
- Consequences of non-payment: If the fee is not paid by the extended deadline, the FDA must treat the submission as not accepted and cannot clear, authorize, or approve it (or any related submission) until payment is made.
- The changes apply only during periods when appropriations for FDA programs or fee collection are lapsed.
Significant Changes to Existing Law The bill modifies existing sections (21 U.S.C. 379h(e) and 21 U.S.C. 379j(f)(1)) that previously required applications to include the full user fee at the time of submission for acceptance. It creates a temporary exception allowing acceptance with deferred payment during funding lapses, while preserving the requirement that fees must ultimately be paid for final action.
Potential Impacts
- On government agencies: Enables the FDA to maintain review timelines for drug and device applications during shutdowns, potentially reducing backlogs once funding resumes.
- On citizens: May speed up patient access to new medicines and devices by avoiding complete halts in the approval process.
- On international relations: No direct effects are specified in the bill.
Main Stakeholders Affected
- The Food and Drug Administration (FDA), which gains flexibility in managing submissions.
- Pharmaceutical and medical device companies, which can submit applications without immediate fee payment during lapses.
- Patients and healthcare providers, who may benefit from continued progress on new treatments.
- Congress and the executive branch, as the bill addresses operational continuity during appropriations disputes.
Notable Legal, Constitutional, or Political Implications The bill focuses on administrative procedures for user fees and does not alter broader constitutional authorities over appropriations. It introduces no new regulatory powers and maintains the existing user-fee framework outside of lapse periods. Politically, it aims to limit the effects of funding gaps on regulated industries and public health without changing the underlying requirement for congressional appropriations.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Recent Actions
- 2026-07-09: Referred to the House Committee on Energy and Commerce.
- 2026-07-09: Introduced in House
- 2026-07-09: Introduced in House
Bill Versions
- Getting Innovations to Patients During Shutdowns Act — issued 2026-07-09 — PDF (5 pages)