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A BILL TO BE ENTITLED
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AN ACT
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relating to prescription drug price disclosure; authorizing a fee; |
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providing an administrative penalty. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Subchapter A, Chapter 441, Health and Safety |
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Code, is amended by adding Section 441.0003 to read as follows: |
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Sec. 441.0003. RULES. The executive commissioner may adopt |
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rules to implement this chapter. |
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SECTION 2. Chapter 441, Health and Safety Code, is amended |
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by adding Subchapter B, and a heading is added to that subchapter to |
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read as follows: |
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SUBCHAPTER B. PRESCRIPTION DRUG PRICE DISCLOSURE |
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SECTION 3. Section 441.0002, Health and Safety Code, is |
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transferred to Subchapter B, Chapter 441, Health and Safety Code, |
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as added by this Act, redesignated as Sections 441.0051, 441.0052, |
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441.0053, and 441.0054, Health and Safety Code, and amended to read |
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as follows: |
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Sec. 441.0051 [441.0002]. ANNUAL REPORT [DISCLOSURE OF |
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DRUG PRICING INFORMATION]. [(a)] Not later than the 15th day of |
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each calendar year, a pharmaceutical drug manufacturer shall submit |
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a report to the department [executive commissioner] stating the |
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current wholesale acquisition cost information for the United |
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States Food and Drug Administration-approved prescription drugs |
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sold in or into this state by that manufacturer. |
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Sec. 441.0052. PRESCRIPTION DRUG PRICE INFORMATION |
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INTERNET WEBSITE. [(b)] The department [executive commissioner] |
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shall develop an Internet website to provide to the general public |
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prescription drug price information submitted under Section |
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441.0051 [Subsection (a)]. The Internet website shall be made |
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available on the department's [Health and Human Services |
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Commission's] Internet website with a dedicated link that is |
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prominently displayed on the home page or by a separate easily |
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identifiable Internet address. |
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Sec. 441.0053. PRESCRIPTION DRUG COST INCREASE |
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INFORMATION. (a) If during a calendar year [(c) This subsection |
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applies only to] a prescription drug with a wholesale acquisition |
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cost of at least $100 for a 30-day supply increases in price by |
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[before the effective date of an increase described by this |
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subsection. Not later than the 30th day after the effective date of |
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an increase of] 40 percent or more over the preceding three calendar |
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years or 15 percent or more in the preceding calendar year in the |
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wholesale acquisition cost of the prescription [a] drug, the [to |
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which this subsection applies, a] pharmaceutical drug manufacturer |
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must include in the annual [shall submit a report to the executive |
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commissioner. The] report submitted under Section 441.0051 [must |
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include] the following information: |
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(1) the name of the prescription drug; |
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(2) whether the prescription drug is a brand name or |
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generic; |
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(3) the effective date of the change in wholesale |
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acquisition cost; |
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(4) aggregate, company-level research and development |
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costs for the most recent year for which final audit data is |
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available; |
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(5) the name of each of the manufacturer's |
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prescription drugs approved by the United States Food and Drug |
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Administration in the previous three calendar years; |
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(6) 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; and |
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(7) a statement regarding the factor or factors that |
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caused the increase in the wholesale acquisition cost and an |
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explanation of the role of each factor's impact on the cost. |
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(b) [(d)] The quality and types of information and data that |
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a pharmaceutical drug manufacturer submits to the department |
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[executive commissioner] under Subsection (a) [(c)] must be |
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consistent with the quality and types of information and data that |
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the manufacturer includes in the manufacturer's annual |
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consolidated report on Securities and Exchange Commission Form 10-K |
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or any other public disclosure. |
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Sec. 441.0054. PUBLICATION OF COST INCREASE INFORMATION. |
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[(e)] Not later than the 60th day after receipt of the report |
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submitted under Section 441.0051 [Subsection (c)], the department |
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[executive commissioner] shall publish the cost increase |
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information required by Section 441.0053 [report] on the |
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department's prescription drug price information [Health and Human |
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Services Commission's] Internet website [described by Subsection |
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(b)]. |
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[(f) The executive commissioner may adopt rules to |
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implement this section.] |
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SECTION 4. Subchapter B, Chapter 441, Health and Safety |
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Code, as added by this Act, is amended by adding Section 441.0055 to |
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read as follows: |
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Sec. 441.0055. FEE. (a) A pharmaceutical drug |
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manufacturer shall submit a fee in the amount provided by |
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department rule with each report submitted under this subchapter. |
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(b) The executive commissioner by rule shall set the fee in |
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the amount necessary for the department to administer this chapter. |
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SECTION 5. Chapter 441, Health and Safety Code, is amended |
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by adding Subchapter C to read as follows: |
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SUBCHAPTER C. ENFORCEMENT |
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Sec. 441.0101. RIGHT TO CORRECT. (a) If the department |
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determines that a pharmaceutical drug manufacturer failed to submit |
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a report or fee required under Subchapter B and the rules adopted |
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under this chapter, the department shall provide written notice of |
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the failure to the manufacturer. |
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(b) On receipt of notice described by Subsection (a), a |
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pharmaceutical drug manufacturer shall submit, as applicable: |
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(1) a report that: |
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(A) complies with Subchapter B and rules adopted |
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under this chapter; and |
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(B) addresses the issues raised in the notice; or |
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(2) the fee required by Section 441.0055. |
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(c) The department may not assess an administrative penalty |
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under Section 441.0102 against a pharmaceutical drug manufacturer |
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that submits to the department the required report or fee, as |
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applicable, on or before the 45th day after the date the |
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manufacturer receives notice under Subsection (a). |
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Sec. 441.0102. ADMINISTRATIVE PENALTY. (a) The department |
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may assess an administrative penalty against a person who violates |
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this chapter or a rule adopted under this chapter. |
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(b) In determining the amount of the penalty, the department |
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shall consider: |
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(1) the person's previous violations; |
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(2) the seriousness of the violation; |
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(3) the person's demonstrated good faith; and |
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(4) any other matters as justice may require. |
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(c) The penalty may not exceed $1,000 a day for each |
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violation. |
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(d) Each day a violation continues may be considered a |
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separate violation. |
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(e) The enforcement of the penalty may be stayed during the |
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time the order is under judicial review if the person pays the |
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penalty to the clerk of the court or files a supersedeas bond with |
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the court in the amount of the penalty. A person who cannot afford |
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to pay the penalty or file the bond may stay the enforcement by |
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filing an affidavit in the manner required by the Texas Rules of |
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Civil Procedure for a party who cannot afford to file security for |
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costs, subject to the right of the board to contest the affidavit as |
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provided by those rules. |
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(f) The attorney general may sue to collect the penalty. |
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Money collected under this section shall be deposited in the state |
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treasury and may be appropriated only to the department for the |
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purposes of administrating this chapter. |
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Sec. 441.0103. ADMINISTRATIVE PROCEDURE. A proceeding to |
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impose an administrative penalty under Section 441.0102 is |
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considered to be a contested case under Chapter 2001, Government |
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Code. |
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SECTION 6. Subchapter C, Chapter 441, Health and Safety |
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Code, as added by this Act, applies only to a violation occurring on |
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or after the effective date of this Act. |
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SECTION 7. This Act takes effect September 1, 2021. |