1 | 1 | | 89R8229 JTZ-F |
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2 | 2 | | By: Oliverson H.B. No. 3086 |
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3 | 3 | | |
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4 | 4 | | |
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5 | 5 | | |
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6 | 6 | | |
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7 | 7 | | A BILL TO BE ENTITLED |
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8 | 8 | | AN ACT |
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9 | 9 | | relating to requirements for pharmaceutical drug manufacturers to |
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10 | 10 | | report prescription drug costs. |
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11 | 11 | | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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12 | 12 | | SECTION 1. Section 441.0051, Health and Safety Code, is |
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13 | 13 | | amended to read as follows: |
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14 | 14 | | Sec. 441.0051. ANNUAL REPORT. (a) Not later than the 15th |
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15 | 15 | | day of each calendar year, a pharmaceutical drug manufacturer shall |
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16 | 16 | | submit a report to the department stating the current wholesale |
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17 | 17 | | acquisition cost information for the United States Food and Drug |
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18 | 18 | | Administration-approved prescription drugs sold in or into this |
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19 | 19 | | state by that manufacturer. |
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20 | 20 | | (b) For a prescription drug with a wholesale acquisition |
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21 | 21 | | cost increase of 40 percent or more over the drug's wholesale |
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22 | 22 | | acquisition cost in the preceding three calendar years or 15 |
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23 | 23 | | percent or more in the preceding calendar year, a pharmaceutical |
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24 | 24 | | drug manufacturer shall include in the annual report required under |
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25 | 25 | | Subsection (a): |
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26 | 26 | | (1) information on whether the prescription drug is a |
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27 | 27 | | brand name drug or generic version of a brand name drug; |
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28 | 28 | | (2) a statement on each factor that caused the |
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29 | 29 | | increase in the wholesale acquisition cost and an explanation of |
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30 | 30 | | the impact of each factor on the cost; |
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31 | 31 | | (3) aggregate, research, and development costs as |
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32 | 32 | | filed with United States Securities and Exchange Commission on Form |
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33 | 33 | | 10-K for the most recent calendar year for which final audit data is |
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34 | 34 | | available; |
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35 | 35 | | (4) the name of each of the manufacturer's |
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36 | 36 | | prescription drugs the United States Food and Drug Administration |
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37 | 37 | | approved in the previous three calendar years; and |
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38 | 38 | | (5) the name of each of the manufacturer's |
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39 | 39 | | prescription drugs that lost patent exclusivity in the United |
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40 | 40 | | States in the previous three calendar years. |
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41 | 41 | | (c) The information a pharmaceutical drug manufacturer |
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42 | 42 | | submits to the department under Subsections (a) and (b) must be |
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43 | 43 | | consistent with the information the manufacturer includes in the |
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44 | 44 | | manufacturer's annual consolidated report filed with the United |
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45 | 45 | | States Securities and Exchange Commission on Form 10-K or any other |
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46 | 46 | | public disclosure. |
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47 | 47 | | SECTION 2. Section 441.0054, Health and Safety Code, is |
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48 | 48 | | amended to read as follows: |
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49 | 49 | | Sec. 441.0054. PUBLICATION OF COST INCREASE INFORMATION. |
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50 | 50 | | Not later than the 60th day after receipt of the report submitted |
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51 | 51 | | under Section 441.0051 [or 441.0053(a)], the department shall |
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52 | 52 | | publish the required cost increase information [required by Section |
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53 | 53 | | 441.0053] on the department's prescription drug price information |
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54 | 54 | | Internet website. |
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55 | 55 | | SECTION 3. Section 441.0102(a), Health and Safety Code, is |
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56 | 56 | | amended to read as follows: |
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57 | 57 | | (a) The department shall [may] assess an administrative |
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58 | 58 | | penalty against a person who violates this chapter or a rule adopted |
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59 | 59 | | under this chapter. |
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60 | 60 | | SECTION 4. Section 441.0053, Health and Safety Code, is |
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61 | 61 | | repealed. |
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62 | 62 | | SECTION 5. As soon as practicable after the effective date |
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63 | 63 | | of this Act, the executive commissioner of the Health and Human |
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64 | 64 | | Services Commission shall adopt rules necessary to implement the |
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65 | 65 | | changes in law made by this Act. |
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66 | 66 | | SECTION 6. This Act takes effect September 1, 2025. |
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