FDA loses power to demand drug-safety tests for cheaper biologics

What it does

This bill modifies FDA requirements for approving biosimilar drugs (cheaper copies of expensive biologic medicines) by making clinical testing more flexible. Instead of requiring manufacturers to always conduct expensive comparative studies proving their biosimilar works identically to the original drug, the FDA can now skip those studies in many cases—but only if the FDA provides written justification upfront. The bill also streamlines the review process by requiring the FDA to issue written determinations about what testing is needed within 60 days of application, and prevents the FDA from adding new testing requirements after that deadline without sponsor agreement or detailed scientific justification.

Why we flagged it

The bill's core mechanism is procedural and substantive reform of FDA biosimilar licensing standards, making approval faster and less testing-intensive while adding procedural safeguards (written justifications, 60-day deadlines). It is not a tax measure, appropriation, or commemorative act.

What the text implies

• Biosimilar manufacturers may face less rigorous comparative efficacy testing, potentially allowing products to market with weaker clinical evidence of equivalence to reference drugs—a trade-off between speed/cost and safety certainty.
• The 60-day deadline for FDA written determinations may create pressure on FDA staff to make determinations quickly or lose the ability to require additional studies, potentially favoring applicants over thorough review.
• Patients switching from reference biologics to newly approved biosimilars with less comparative data may experience unexpected differences in efficacy or immunogenicity not caught in streamlined review.
• The bill's discretionary language ('may determine', 'as appropriate') gives the FDA significant power to decide which biosimilars get expedited treatment, creating potential for inconsistent application across manufacturers.

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

Who it affects

Ordinary patients and taxpayers benefit from faster, cheaper biosimilar approvals that increase competition and lower drug costs. The bill protects patients by requiring the FDA to justify any testing requirements in writing and preventing surprise regulatory demands mid-review. However, the flexibility to skip comparative clinical studies creates a small risk that some biosimilars could reach market with less rigorous safety data than previously required.

Who stands to gain

• biosimilar manufacturers
• generic/biosimilar drug companies
• health insurers and pharmacy benefit managers (via lower drug costs)
• patients with high out-of-pocket costs for biologics

Named in the bill

FDA, Section 351 of the Public Health Service Act, Section 744G of the Federal Food, Drug, and Cosmetic Act, biosimilar manufacturers, reference product sponsors, Biogen (BIIB)

Where it stands

2 cosponsors: 1 Democrats, 1 Republicans.

• Apr 10, 2025 — Introduced · Congress.gov: “Introduced in Senate”
• Apr 10, 2025 — Referred to Senate Committee on Health, Education, Labor, and Pensions · Congress.gov: “Read twice and referred to the Committee on Health, Education, Labor, and Pensions”
• Jul 22, 2026 — Reported out of committee · Congress.gov: “Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature…”

Dates and quoted wording are Congress.gov's action record; the timeline shows status changes, not every procedural step.

Money around this bill

12 lobbying clients named this bill on 15 disclosure filings across 2 quarters, Dec 2025 to Jun 2026. Those filings disclosed $27,372,990 in lobbying spend. A filing names 26 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 93% of bills with at least one filing.

Rand Paul, the sponsor, reported $94,645 in PAC receipts in the 2026 cycle.

• Pharmaceutical Research and Manufacturers of America — $15,770,000 on 2 filings
• Pharmaceutical Care Management Association — $3,282,990 on 1 filing
• Amgen Inc — $2,440,000 on 1 filing
• Biotechnology Innovation Organization — $2,360,000 on 1 filing
• Gsk (fka Glaxosmithkline Inc.) — $890,000 on 1 filing

Lobbying Disclosure Act filings through Jul 22, 2026. A filing shows who paid to lobby on a bill it names, not what changed.