GENERAL ASSEMBLY OF NORTH CAROLINA SESSION 2025 H 1 HOUSE BILL 624 Short Title: Prescription Drug Pricing. (Public) Sponsors: Representatives Crawford, Clark, Cervania, and Belk (Primary Sponsors). For a complete list of sponsors, refer to the North Carolina General Assembly web site. Referred to: Rules, Calendar, and Operations of the House April 2, 2025 *H624 -v-1* A BILL TO BE ENTITLED 1 AN ACT TO PROMOTE PRESCRIPTION DRUG PRICE TRANSPARENCY. 2 The General Assembly of North Carolina enacts: 3 SECTION 1. Chapter 90 of the General Statutes is amended by adding a new Article 4 to read: 5 "Article 4D. 6 "Prescription Drug Transparency. 7 "§ 90-85.55. Definitions. 8 The following definitions apply in this Article: 9 (1) Generic drug. – A drug that is identical or bioequivalent to a brand-name drug 10 in dosage form, safety, strength, route of administration, quality, performance 11 characteristics, and intended use. 12 (2) Interested parties. – All of the following: 13 a. State agencies that (i) purchase prescription drugs or (ii) employ 14 prescribers. 15 b. Health insurance companies. 16 c. Health care service plan providers. 17 d. Pharmacy benefits managers. 18 (3) Manufacturer. – An entity or an agent of an entity that produces, prepares, 19 propagates, compounds, processes, packages, repackages, or labels a 20 brand-name or generic drug. "Manufacturer" does not include an entity 21 engaged in the preparation and dispensing of a brand-name or generic drug 22 pursuant to a prescription. 23 (4) Prescriber. – Any person authorized under the laws of this State to issue a 24 prescription order. 25 (5) Prescription drug. – Defined in G.S. 90-85.3. 26 (6) Prescription order. – Defined in G.S. 90-85.3. 27 (7) Secretary. – The Secretary of the Department of Health and Human Services. 28 (8) Substantial price increase. – Any increase in the price charged by a 29 manufacturer for a prescription drug that would have the impact of increasing 30 the cost of the drug by ten percent (10%) or more over 12 months. 31 "§ 90-85.56. Required notifications and disclosures. 32 (a) Price Increases. – A manufacturer shall notify all interested parties of an upcoming 33 substantial price increase at least 60 days prior to the increase. Within 30 days after the 34 General Assembly Of North Carolina Session 2025 Page 2 House Bill 624-First Edition notification required under this subsection, the manufacturer shall disclose the following to all 1 interested parties: 2 (1) A justification for the proposed price increase. The manufacturer may limit 3 the information in the justification to that which is publicly available. 4 (2) The previous year's marketing budget for the drug. 5 (3) The date and price of acquisition if the drug was not developed by the 6 manufacturer. 7 (4) A schedule of price increases for the drug for the previous five years. 8 (b) New Products. – A manufacturer shall notify all interested parties of the price of any 9 new prescription drug within three days after the manufacturer receives approval by the U.S. 10 Food and Drug Administration. Within 30 days after the notification required under this 11 subsection, the manufacturer shall disclose the following to all interested parties: 12 (1) A justification for the price. The manufacturer may limit the contents of the 13 justification to publicly available information. 14 (2) The expected marketing budget for the drug. 15 (3) The date and price of acquisition if the drug was not developed by the 16 manufacturer. 17 (c) Risk of Dependency. – If a manufacturer or an agent of the manufacturer meets or 18 otherwise communicates with a prescriber for the purpose of marketing a prescription drug, the 19 manufacturer or the manufacturer's agent shall disclose to the prescriber if any ingredient in the 20 prescription drug it is marketing is known to pose a risk of dependency in humans. 21 "§ 90-85.57. Penalty for failure to report. 22 The Secretary shall assess a civil penalty against any manufacturer that fails to report the 23 information required under G.S. 66-462(a) and (b). The amount of the penalty shall not exceed 24 one thousand dollars ($1,000) for each day the manufacturer fails to submit the required 25 information. The clear proceeds of any civil penalties assessed pursuant to this section shall be 26 remitted to the Civil Penalty and Forfeiture Fund in accordance with G.S. 115C-457.2. Chapter 27 150B of the General Statutes applies to proceedings for the assessment of civil penalties under 28 this section. 29 "§ 90-85.58. No price limitations. 30 Nothing in this Article shall be construed as a limitation upon the ability of a manufacturer 31 to charge any price for a prescription drug permitted by law. 32 "§ 90-85.59. Report and data collection by the Secretary; public portal. 33 (a) Plan for Implementation. – The Secretary shall develop a plan to collect data from 34 manufacturers related to the cost and pricing of prescription drugs in order to provide 35 transparency in and accountability for prescription drug pricing. The Secretary shall consult with 36 other state and national agencies and organizations to determine how to institute such data 37 collection. The Secretary shall submit a plan regarding how to implement these requirements as 38 well as any findings and recommendations to the Joint Legislative Oversight Committee on 39 Health and Human Services by February 1, 2026. 40 (b) Public Portal. – The Secretary shall also implement an online portal to provide the 41 public with electronic access to the notifications, reports, and other disclosures required by this 42 Article. 43 (c) Annual Report. – Beginning December 1, 2026, and annually thereafter, the Secretary 44 shall report to the Joint Legislative Oversight Committee on Health and Human Services the 45 following information about prescription drugs: 46 (1) The 25 most frequently prescribed drugs in the State. 47 (2) The 25 costliest drugs as determined by the total amount spent on those drugs 48 in the State. 49 (3) The 25 prescription drugs with the highest year-over-year cost increases as 50 determined by the total amount spent on those drugs in the State." 51 General Assembly Of North Carolina Session 2025 House Bill 624-First Edition Page 3 SECTION 2. This act becomes effective October 1, 2025. 1