Bill Summaries: S411 (2021)

  • Summary date: Mar 30 2021 - View summary

    Enacts new Article 47A of GS Chapter 66, to be titled "The Prescription Drug Transparency Act." Lists definitions applicable to this act. Requires manufacturers to notify interested parties, which include State agencies that purchase prescription drugs or have specified classes of employees, of upcoming substantial price increases (defined as an increase that causes the cost of a drug to rise by 10% or more in 12 months) at least 60 days in advance, and within 30 days after that notification, to provide information on the reason for the increase as well as a schedule of price increases for the previous five years, the previous year's marketing budget for the drug, and date and price of acquisition if the drug was not developed by the manufacturer. Requires manufacturers to also provide notification of the price of new products within three days of FDA approval, and within 30 days after that a reason for the price, expected marketing budget, and date and price of acquisition if the drug was not developed by the manufacturer. Limits requirement for price justification to publicly available information.  Mandates disclosure of any ingredients known to pose a risk of dependency in humans by manufacturers who market a drug to a prescriber. Provides penalty of up to $1,000 per day for each day the manufacturer fails to submit the required information, with proceeds remitted to the Civil Penalty and Forfeiture Fund. Makes the Administrative Procedure Act, GS Chapter 150B, applicable to proceedings for the assessment of civil penalties under the Article. Provides there is no upper limit for a price as allowed by law.  Requires the Secretary of the Department of Health and Human Services (Secretary) to develop a plan to collect data from manufacturers regarding the cost and pricing of prescription drugs and to set up an online portal to provide public access to the notifications, reports, and disclosures required by this Article. Directs the Secretary to consult with other state and national agencies and organizations regarding data collection, and to submit its findings and recommendations to the specified NCGA committee by February 1, 2022. Mandates the Secretary report annually, beginning December 1, 2022, to the specified NCGA committee regarding the top 25 of each of the following: (1) most frequently prescribed drugs, (2) costliest drugs, and (3) drugs with the highest year-over-year cost increases as determined by the total amount spent in this state.  Effective October 1, 2021.