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A BILL TO BE ENTITLED
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AN ACT
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relating to requirements for pharmaceutical drug manufacturers to |
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report prescription drug costs. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Section 441.0051, Health and Safety Code, is |
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amended to read as follows: |
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Sec. 441.0051. ANNUAL REPORT. (a) Not later than the 15th |
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day of each calendar year, a pharmaceutical drug manufacturer shall |
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submit a report to the department stating the current wholesale |
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acquisition cost information for the United States Food and Drug |
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Administration-approved prescription drugs sold in or into this |
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state by that manufacturer. |
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(b) For a prescription drug with a wholesale acquisition |
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cost increase of 40 percent or more over the drug's wholesale |
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acquisition cost in the preceding three calendar years or 15 |
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percent or more in the preceding calendar year, a pharmaceutical |
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drug manufacturer shall include in the annual report required under |
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Subsection (a): |
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(1) information on whether the prescription drug is a |
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brand name drug or generic version of a brand name drug; |
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(2) a statement on each factor that caused the |
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increase in the wholesale acquisition cost and an explanation of |
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the impact of each factor on the cost; |
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(3) aggregate, research, and development costs as |
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filed with United States Securities and Exchange Commission on Form |
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10-K for the most recent calendar year for which final audit data is |
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available; |
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(4) the name of each of the manufacturer's |
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prescription drugs the United States Food and Drug Administration |
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approved in the previous three calendar years; and |
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(5) the name of each of the manufacturer's |
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prescription drugs that lost patent exclusivity in the United |
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States in the previous three calendar years. |
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(c) The information a pharmaceutical drug manufacturer |
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submits to the department under Subsections (a) and (b) must be |
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consistent with the information the manufacturer includes in the |
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manufacturer's annual consolidated report filed with the United |
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States Securities and Exchange Commission on Form 10-K or any other |
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public disclosure. |
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SECTION 2. Section 441.0054, Health and Safety Code, is |
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amended to read as follows: |
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Sec. 441.0054. PUBLICATION OF COST INCREASE INFORMATION. |
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Not later than the 60th day after receipt of the report submitted |
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under Section 441.0051 [or 441.0053(a)], the department shall |
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publish the required cost increase information [required by Section |
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441.0053] on the department's prescription drug price information |
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Internet website. |
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SECTION 3. Section 441.0102(a), Health and Safety Code, is |
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amended to read as follows: |
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(a) The department shall [may] assess an administrative |
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penalty against a person who violates this chapter or a rule adopted |
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under this chapter. |
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SECTION 4. Section 441.0053, Health and Safety Code, is |
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repealed. |
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SECTION 5. As soon as practicable after the effective date |
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of this Act, the executive commissioner of the Health and Human |
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Services Commission shall adopt rules necessary to implement the |
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changes in law made by this Act. |
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SECTION 6. This Act takes effect September 1, 2025. |