FDA keeps reviewing drugs during shutdowns—but companies must pay up after.
H.R. 9635 — Getting Innovations to Patients During Shutdowns Act · Filed by Kevin Mullin (D-CA) · Introduced Jul 9, 2026 · Referred to committee
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What it does
This bill allows the FDA to continue reviewing drug and device applications during government shutdowns even if companies haven't paid their application fees yet, but requires them to pay within 7 days after the shutdown ends or their applications are rejected. It keeps the FDA's review process moving during budget lapses without forgiving fees or letting incomplete applications slip through.
Why we flagged it
The bill's core function is procedural: it preserves FDA review capacity during appropriations lapses by deferring fee collection temporarily. It is not a substantive deregulation, subsidy, or immunity grant—it is a shutdown-continuity measure.
What the text implies
- The 7-day post-shutdown payment deadline may create cash-flow pressure on smaller biotech firms with limited liquidity, potentially favoring larger companies with deeper reserves.
- By allowing FDA review to proceed without upfront fees during shutdowns, the bill implicitly shifts the risk of non-payment to the FDA (and taxpayers), though the fee-collection mechanism is preserved.
- The bill does not address what happens if a shutdown extends beyond the application review cycle—ambiguity about whether the extended deadline applies to multi-stage reviews or only initial filings.
Section numbers refer to the bill text the analysis read — linked under Primary records below.
Who it affects
Ordinary people benefit from faster access to new drugs and medical devices—the bill prevents shutdown-induced delays that could postpone life-saving treatments. The fee-deferral mechanism is temporary and conditional (payment still required), so it does not create a permanent subsidy or reduce FDA oversight.
Who stands to gain
- pharmaceutical companies
- medical device manufacturers
- biotech firms with pending FDA submissions
Named in the bill
FDA (Food and Drug Administration), Federal Food, Drug, and Cosmetic Act, Section 736 (human drug submissions), Section 738 (device submissions), Baxter International (BSX), Intuitive Surgical (ISRG), Medtronic (MDT)
Where it stands
- Jul 9, 2026 — Introduced · Congress.gov: “Introduced in House”
- Jul 9, 2026 — Referred to House Committee on Energy and Commerce · Congress.gov: “Referred to the House Committee on Energy and Commerce”
Dates and quoted wording are Congress.gov's action record; the timeline shows status changes, not every procedural step.
How this was measured
Analysis — Quorum's AI read the bill text published by Congress.gov (2,887 characters) on Aug 12, 2026. Section numbers in the findings refer to that text, linked below; transparency and hidden-provision scores are compared against the median of 16,222 analysed bills.
Status and sponsors — Congress.gov's bill record — actions, committee referrals and cosponsors — loaded nightly. The timeline shows status changes, not every procedural action.
As of — page rendered 2026-10-20.
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