HB 4347 Summary

• Drug manufacturers must report to the Department of Insurance and Financial Services within 30 days when increasing wholesale acquisition cost of qualified prescription drugs by 15% or more annually or 40% or more over 3 years.

• Reports must include drug name, type, cost increase percentage, company-level R&D costs, publicly-funded R&D costs, and FDA approval and patent exclusivity information from the previous 5 years.

• Manufacturers must notify the department within 3 calendar days when introducing new prescription drugs at costs exceeding the Medicare Part D specialty drug threshold, including information on FDA breakthrough therapy designation and acquisition or development costs.

• Department shall prepare annual reports with aggregate data (excluding competitively sensitive information) and post them publicly on the department website; manufacturer reports are exempt from freedom of information disclosure.

• Violations subject to civil fines up to $100,000 per month for non-compliance; takes effect January 1, 2023, contingent on enactment of HB 4353.