Congress blocks FDA from regulating lab tests—no safety review required

What it does

This bill blocks the FDA from spending any federal money to implement, administer, or enforce a new rule regulating laboratory-developed tests (LDTs)—medical tests designed and performed by individual labs rather than mass-produced devices. The rule, submitted in May 2024, would have brought LDTs under FDA oversight for the first time. By cutting off funding, the bill effectively prevents the FDA from enforcing the rule.

Why we flagged it

The bill's operative mechanism is a funding prohibition that prevents FDA enforcement of a specific rule. While framed as a narrow defunding measure, it functions as a de facto deregulation of laboratory-developed tests by removing the agency's ability to oversee them.

What the text implies

• The bill targets a rule that had not yet taken effect, suggesting it was introduced to preempt FDA authority before implementation began. This is a prospective defunding strategy, not a reversal of existing enforcement.
• Laboratory-developed tests are currently regulated under a 'enforcement discretion' framework—the FDA has largely not enforced device rules against LDTs. The May 2024 rule would have formalized FDA oversight. Blocking funding prevents a shift from informal to formal regulation.
• LDTs include genetic tests, cancer diagnostics, and COVID tests. Removing FDA oversight may increase market entry for unvalidated tests, potentially harming patients who rely on test accuracy for treatment decisions.
• The bill's 'substantially similar rule' language may prevent the FDA from issuing any future LDT regulation without a new appropriations fight, creating a structural defunding precedent.

Section numbers refer to the bill text the analysis read — linked under Primary records below.

Who it affects

Ordinary people lose access to FDA-enforced safety and accuracy standards for laboratory tests that directly affect their medical diagnosis and treatment. Labs retain the ability to market tests without proving they work or are safe, shifting quality assurance burden to individual providers and patients.

Who stands to gain

• laboratory-developed test manufacturers
• clinical laboratories
• genetic testing companies
• diagnostic labs operating without FDA certification

Named in the bill

Food and Drug Administration (FDA), U.S. House of Representatives, Committee on Energy and Commerce, Rep. Finstad, Rep. Crenshaw, Federal Register, 89 Fed. Reg. 37286

Where it stands

7 cosponsors: 7 Republicans.

• Feb 21, 2025 — Introduced · Congress.gov: “Introduced in House”
• Feb 21, 2025 — 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.

Money around this bill

1 lobbying clients named this bill on 1 disclosure filings across 1 quarter, Dec 2025 to Dec 2025. Those filings disclosed $154,425 in lobbying spend. A filing names 34 bills on average, so that figure is what each filing reported, not a share belonging to this bill.

More lobbying clients named this bill than 0% of bills with at least one filing.

Brad Finstad, the sponsor, reported $981,433 in PAC receipts in the 2026 cycle.

• College of American Pathologists — $154,425 on 1 filing

Lobbying Disclosure Act filings through Jan 20, 2026. A filing shows who paid to lobby on a bill it names, not what changed.