HB3256 - Affordable Drug Manufacturing Act Summary

• Creates the Affordable Drug Manufacturing Act, authorizing the Department of Public Health to enter into partnerships to manufacture or distribute generic prescription drugs at lower prices to increase competition, reduce costs, and improve access for public and private purchasers.

• Requires partnerships to produce generic drugs at prices resulting in savings, prioritize drugs for chronic and high-cost conditions, and include at least one form of insulin if a viable manufacturing pathway exists.

• Establishes price-setting requirements considering FDA user fees, drug application costs amortized over 5 years, mandatory rebates, production costs, research and development, and start-up costs, with drugs sold at transparent prices without rebates except federally required ones.

• Mandates the Department consult with public agencies, health insurers, hospitals, and pharmacy benefit managers to identify targeted drugs and determine procurement volumes over multi-year periods.

• Requires feasibility report by July 1, 2025 on direct drug manufacturing options and status report by July 1, 2024 on targeted drugs and impact analysis; exempts nonpublic information obtained under the Act from Freedom of Information Act disclosure; takes effect July 1, 2023.