Section 26.1-36.10-02 - Disclosure of drug pricing information1. Each drug manufacturer shall submit a report to the commissioner no later than the fifteenth day of January, April, July, and October with the current wholesale acquisition cost information for the prescription drugs sold in or into the state by that drug manufacturer.2.a. Not more than thirty days after an increase in wholesale acquisition cost of forty percent or greater over the preceding five calendar years or ten percent or greater in the preceding twelve months for a prescription drug with a wholesale acquisition cost of seventy dollars or more for a manufacturer-packaged drug container, a drug manufacturer shall submit a report to the commissioner. The report must contain the following information: (2) Whether the drug is a brand name or a generic;(3) The effective date of the change in wholesale acquisition cost;(4) Aggregate, company-level research and development costs for the previous calendar year;(5) Aggregate rebate amounts paid to each pharmacy benefits manager for the previous calendar year;(6) The name of each of the drug manufacturer's drugs approved by the United States food and drug administration in the previous five calendar years;(7) The name of each of the drug manufacturer's drugs that lost patent exclusivity in the United States in the previous five calendar years; and(8) A concise statement of rationale regarding the factor or factors that caused the increase in the wholesale acquisition cost, such as raw ingredient shortage or increase in pharmacy benefits manager rebates.b. The quality and types of information and data a drug manufacturer submits to the commissioner pursuant to this subsection must be the same as the quality and types of information and data the drug manufacturer includes in the drug manufacturer's annual consolidated report on securities and exchange commission form 10-K or any other public disclosure.3. A drug manufacturer shall notify the commissioner in writing if the drug manufacturer is introducing a new prescription drug to market at a wholesale acquisition cost that exceeds the threshold set for a specialty drug under the Medicare part D program.a. The notice must include a concise statement of rationale regarding the factor or factors that caused the new drug to exceed the Medicare part D program price.b. The drug manufacturer shall provide the written notice within three calendar days following the release of the drug in the commercial market.c. A drug manufacturer may make the notification pending approval by the United States food and drug administration if commercial availability is expected within three calendar days following the approval.Added by S.L. 2021 , ch. 242( HB 1032 ), § 1, eff. 7/1/2021.