| 1 | 1 | | S.B. No. 241 |
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| 2 | 2 | | |
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| 3 | 3 | | |
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| 4 | 4 | | AN ACT |
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| 5 | 5 | | relating to written notification provided by drug manufacturers |
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| 6 | 6 | | regarding the cause of generic or biosimilar insulin prescription |
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| 7 | 7 | | drug unavailability. |
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| 8 | 8 | | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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| 9 | 9 | | SECTION 1. Chapter 439, Health and Safety Code, is amended |
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| 10 | 10 | | by adding Subchapter D to read as follows: |
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| 11 | 11 | | SUBCHAPTER D. INSULIN |
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| 12 | 12 | | Sec. 439.101. DEFINITION. In this subchapter, |
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| 13 | 13 | | "manufacturer" has the meaning assigned by Section 531.070, |
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| 14 | 14 | | Government Code. |
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| 15 | 15 | | Sec. 439.102. WRITTEN VERIFICATION REQUIRED FOR BRAND NAME |
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| 16 | 16 | | INSULIN DRUG MANUFACTURER. (a) The manufacturer of a brand name |
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| 17 | 17 | | insulin prescription drug for which a generic or biosimilar |
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| 18 | 18 | | prescription drug is not available and that is included in the |
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| 19 | 19 | | Medicaid vendor drug program formulary must submit to the Health |
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| 20 | 20 | | and Human Services Commission a written verification stating |
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| 21 | 21 | | whether or not the unavailability of the generic or biosimilar |
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| 22 | 22 | | prescription drug is the result, wholly or partly, of: |
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| 23 | 23 | | (1) a scheme by the manufacturer to pay a generic or |
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| 24 | 24 | | biosimilar prescription drug manufacturer to delay manufacturing |
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| 25 | 25 | | or marketing the generic or biosimilar drug; |
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| 26 | 26 | | (2) a legal or business strategy to extend the life of |
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| 27 | 27 | | a patent on the brand name prescription drug; |
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| 28 | 28 | | (3) the manufacturer directly manipulating a patent on |
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| 29 | 29 | | the brand name prescription drug; or |
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| 30 | 30 | | (4) the manufacturer facilitating an action described |
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| 31 | 31 | | by Subdivisions (1)-(3) on behalf of another entity. |
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| 32 | 32 | | (b) The executive commissioner shall adopt rules |
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| 33 | 33 | | prescribing the form and manner for submission of the written |
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| 34 | 34 | | verification required under Subsection (a). |
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| 35 | 35 | | SECTION 2. This Act takes effect September 1, 2024. |
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| 36 | 36 | | ______________________________ ______________________________ |
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| 37 | 37 | | President of the Senate Speaker of the House |
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| 38 | 38 | | I hereby certify that S.B. No. 241 passed the Senate on |
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| 39 | 39 | | March 23, 2023, by the following vote: Yeas 31, Nays 0. |
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| 40 | 40 | | ______________________________ |
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| 41 | 41 | | Secretary of the Senate |
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| 42 | 42 | | I hereby certify that S.B. No. 241 passed the House on |
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| 43 | 43 | | May 12, 2023, by the following vote: Yeas 139, Nays 1, two |
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| 44 | 44 | | present not voting. |
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| 45 | 45 | | ______________________________ |
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| 46 | 46 | | Chief Clerk of the House |
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| 47 | 47 | | Approved: |
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| 48 | 48 | | ______________________________ |
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| 49 | 49 | | Date |
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| 50 | 50 | | ______________________________ |
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| 51 | 51 | | Governor |
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