Dr. Rand Paul Introduces Legislation to Modernize FDA Prescription Drug Approvals and Lower Drug Prices

FORIMMEDIATE RELEASE:
April 8th, 2025
Contact:Press_Paul@paul.senate.gov, 202-224-4343

Washington, D.C. –Today, U.S. Senator Rand Paul (R-KY) introduced legislation to streamline the approval process for biosimilars by eliminating costly and redundantclinicalstudy requirements. Dr. Paul’sExpedited Access to Biosimilars Actwill increase market competition, lower drug prices, and increaseaccess to more life-saving treatments.
“For too long, the FDA 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 requirementsthat create unjustified barriers, further delaying competition in the market. For years, biopharmaceutical researchers have argued that new and advanced methods of determining biosimilar clinical equivalence in early development have eliminated the need for late-stage humanstudies. When a biosimilar proves it is safe, effective, and similar to the brand name product in the early stages of its analyticaland safetyassessment, there’s no scientific justification to delay access.”
BACKGROUND
Senator Paul’s legislation will:
Regulatory agencies in the U.K. and European Union (EU)have dropped theblanketrequirement forthese redundant studies after years of research determined that early-stagePKstudies were sufficient for biosimilar approval. The regulatory overreach by the FDA often dictates the practice of medicineand slows accessrather than making safety and effectiveness determinations of medications. The agency’s increasingdemandsofstudiesleave little room for physicians and patients to make outcome-oriented decisions for themselves.
It is time for the agency to start thinking like an innovator, not an impediment to innovation. By modernizing and streamlining the FDA biosimilar approval process, Congress can help lower patients’ prescription costs without compromising safety or efficacy.
Read full the billHERE.
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