| 1 | 1 | | 88R458 KKR-D |
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| 2 | 2 | | By: Talarico H.B. No. 2529 |
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| 3 | 3 | | |
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| 4 | 4 | | |
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| 5 | 5 | | A BILL TO BE ENTITLED |
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| 6 | 6 | | AN ACT |
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| 7 | 7 | | relating to written notification provided by drug manufacturers |
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| 8 | 8 | | regarding the cause of generic insulin prescription drug |
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| 9 | 9 | | unavailability. |
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| 10 | 10 | | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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| 11 | 11 | | SECTION 1. Chapter 439, Health and Safety Code, is amended |
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| 12 | 12 | | by adding Subchapter D to read as follows: |
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| 13 | 13 | | SUBCHAPTER D. INSULIN |
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| 14 | 14 | | Sec. 439.101. DEFINITION. In this subchapter, |
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| 15 | 15 | | "manufacturer" has the meaning assigned by Section 531.070, |
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| 16 | 16 | | Government Code. |
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| 17 | 17 | | Sec. 439.102. WRITTEN VERIFICATION REQUIRED FOR BRAND NAME |
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| 18 | 18 | | INSULIN DRUG MANUFACTURER. (a) The manufacturer of a brand name |
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| 19 | 19 | | insulin prescription drug for which a generic prescription drug is |
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| 20 | 20 | | not available and that is included in the Medicaid vendor drug |
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| 21 | 21 | | program formulary must submit to the Health and Human Services |
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| 22 | 22 | | Commission a written verification stating whether or not the |
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| 23 | 23 | | unavailability of the generic prescription drug is the result, |
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| 24 | 24 | | wholly or partly, of: |
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| 25 | 25 | | (1) a scheme by the manufacturer to pay a generic |
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| 26 | 26 | | prescription drug manufacturer to delay marketing the generic drug; |
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| 27 | 27 | | (2) a legal or business strategy to extend the life of |
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| 28 | 28 | | a patent on the brand name prescription drug; |
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| 29 | 29 | | (3) the manufacturer directly manipulating a patent on |
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| 30 | 30 | | the brand name prescription drug; or |
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| 31 | 31 | | (4) the manufacturer facilitating an action described |
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| 32 | 32 | | by Subdivisions (1)-(3) on behalf of another entity. |
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| 33 | 33 | | (b) The executive commissioner shall adopt rules |
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| 34 | 34 | | prescribing the form and manner for submission of the written |
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| 35 | 35 | | verification required under Subsection (a). |
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| 36 | 36 | | SECTION 2. This Act takes effect September 1, 2024. |
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