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Pharma trade groups urge caution as committee advances bill to widen local access to limited-distribution specialty drugs
Summary
House Bill 1531, aimed at allowing Arkansas specialty pharmacies to obtain limited-distribution drugs locally, passed the committee after proponents said it would improve patient access; national manufacturers warned the measure is ambiguous and could create compliance and safety issues without clearer definitions and process.
The Senate Insurance & Commerce Committee voted to advance House Bill 1531 after hearing competing testimony about access to limited-distribution specialty medications.
Representative Brandon Acre, the sponsor, said the bill would allow Arkansas-based specialty pharmacies and hospital pharmacies that meet manufacturer criteria to obtain limited-distribution drugs now often routed through out-of-state mail-order channels. Acre cited patient-access concerns during weather events and emergencies as examples where local access matters.
Pharmaceutical industry trade groups testified in opposition. Kip Snyder, national vice president of state policy for PhRMA, told the committee the bill’s language lacks clear definitions and could create confusion about which limited distribution networks (LDNs) fall within scope. Russell Polk of BIO (the Biotechnology Innovation Organization) said manufacturers use limited distribution networks for safety, special-handling, REMS (Risk Evaluation and Mitigation Strategy) compliance and to protect supply integrity.
Sponsor Acre and other proponents said an amended version provides due process: pharmacies must meet FDA guidance and manufacturer handling and storage requirements; manufacturers retain the ability to review requests and require reasonable assurances for safety and handling. The bill as amended creates an application path to request inclusion and offers a waiver route through the State Board of Pharmacy.
Committee action: After testimony and an amendment that clarified handling and storage requirements and added a waiver process, the committee approved HB 1531 by voice vote and reported it favorably.
Why it matters: The bill seeks to expand local access to expensive specialty medications for Arkansas patients while balancing manufacturer concerns about safety and supply chain integrity.
Next steps: The amended bill was reported favorably and will proceed through the legislative process.
