Section 441.0053 - Prescription Drug Cost Increase Report and Information(a) This subsection applies only to a prescription drug with a wholesale acquisition cost of at least $100 for a 30-day supply before the effective date of an increase described by this subsection. Not later than the 30th day after the effective date of an increase of 40 percent or more over the preceding three calendar years or 15 percent or more in the preceding calendar year in the wholesale acquisition cost of a prescription drug to which this subsection applies, a pharmaceutical drug manufacturer shall submit a report to the executive commissioner. The report must include the following information: (1) the name of the prescription drug;(2) whether the prescription drug is a brand name or generic;(3) the effective date of the change in wholesale acquisition cost; and(4) a statement regarding the factor or factors that caused the increase in the wholesale acquisition cost and an explanation of the role of each factor's impact on the cost.(b) If during a calendar year a prescription drug with a wholesale acquisition cost of at least $100 for a 30-day supply increases in price by 40 percent or more over the preceding three calendar years or 15 percent or more in the preceding calendar year in the wholesale acquisition cost of the prescription drug, the pharmaceutical drug manufacturer must include in the annual report submitted under Section 441.0051 the following information: (1) aggregate, company-level research and development costs for the most recent year for which final audit data is available;(2) the name of each of the manufacturer's prescription drugs approved by the United States Food and Drug Administration in the previous three calendar years; and(3) the name of each of the manufacturer's prescription drugs that lost patent exclusivity in the United States in the previous three calendar years.(c) The quality and types of information and data that a pharmaceutical drug manufacturer submits to the department under Subsections (a) and (b) must be consistent with the quality and types of information and data that the manufacturer includes in the manufacturer's annual consolidated report on Securities and Exchange Commission Form 10-K or any other public disclosure.Tex. Health and Safety Code § 441.0053
Renumbered from Tex. Health and Safety Code § 441.0002 and amended by Acts 2021, Texas Acts of the 87th Leg. - Regular Session, ch. 50,Sec. 3, eff. 9/1/2021.Added by Acts 2019, Texas Acts of the 86th Leg.- Regular Session, ch. 1291,Sec. 1, eff. 9/1/2019.