Dr. Rand Paul’s Legislation to Lower Drug Prices Unanimously Advances Out of Committee

FOR IMMEDIATE RELEASE:

July 23, 2026

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Dr. Rand Paul's Legislation to Lower Drug Prices Unanimously Advances Out of Committee

Washington, D.C. - Yesterday, the Senate Health, Education, Labor, and Pensions (HELP) Committee unanimously advanced legislation introduced by U.S. Senator Rand Paul (R-KY) to streamline the approval process for biosimilars by eliminating costly and redundant clinical study requirements. Dr. Paul's Expedited Access to Biosimilars Act will increase market competition, lower drug prices, and increase access to more life-saving treatments.

"The FDA in previous administrations has forced companies to jump through bureaucratic hoops and produce redundant clinical studies that offer no new meaningful scientific information for the approval process," said Senator Paul. "My bill puts an end to wasteful and repetitive clinical requirements that create unjustified barriers, further delaying competition in the market. Biopharmaceutical researchers have argued that new and advanced methods of determining biosimilar clinical equivalence in early development have eliminated the need for late-stage human studies. When a biosimilar proves it is safe, effective, and similar to the brand-name product in the early stages of its analytical and safety assessment, there's noscientific justification to delay access."

BACKGROUND

Senator Paul's legislation will:

• Retain the FDA's requirement for pharmacokinetic (PK) and immunogenicity studies. PK and immunogenicity studies are essential because they help gauge how the body metabolizes and reacts to a drug. It will eliminate the FDA's blanket requirement of pharmacodynamics (PD) and Clinical Efficacy Requirements (CES) since they would be unnecessary if the previous tests are successful. No biosimilar that has passed a PK and an immunogenicity study has failed to gain FDA approval.
• Require the FDA to justify the additional study requirements within 60 days of a biosimilar manufacturer's initial meeting with the FDA, ensuring that regulatory decisions are based on scientific necessity, not outdated bureaucracy.

Regulatory agencies in the U.K. and European Union (EU) have dropped the blanket requirement for these redundant studies after years of research determined that early-stage PK studies were sufficient for biosimilar approval. The regulatory overreach by the FDA often dictates the practice of medicine and slows access rather than making safety and effectiveness determinations of medications. The agency's increasing demands for studies leave little room for physicians and patients to make outcome-oriented decisions for themselves.

Read full the bill HERE.

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