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A BILL TO BE ENTITLED
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AN ACT
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relating to written notification provided by drug manufacturers |
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regarding the cause of generic or biosimilar insulin prescription |
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drug unavailability. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Chapter 439, Health and Safety Code, is amended |
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by adding Subchapter D to read as follows: |
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SUBCHAPTER D. INSULIN |
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Sec. 439.101. DEFINITION. In this subchapter, |
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"manufacturer" has the meaning assigned by Section 531.070, |
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Government Code. |
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Sec. 439.102. WRITTEN VERIFICATION REQUIRED FOR BRAND NAME |
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INSULIN DRUG MANUFACTURER. (a) The manufacturer of a brand name |
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insulin prescription drug for which a generic or biosimilar |
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prescription drug is not available and that is included in the |
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Medicaid vendor drug program formulary must submit to the Health |
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and Human Services Commission a written verification stating |
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whether or not the unavailability of the generic or biosimilar |
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prescription drug is the result, wholly or partly, of: |
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(1) a scheme by the manufacturer to pay a generic or |
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biosimilar prescription drug manufacturer to delay manufacturing |
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or marketing the generic or biosimilar drug; |
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(2) a legal or business strategy to extend the life of |
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a patent on the brand name prescription drug; |
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(3) the manufacturer directly manipulating a patent on |
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the brand name prescription drug; or |
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(4) the manufacturer facilitating an action described |
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by Subdivisions (1)-(3) on behalf of another entity. |
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(b) The executive commissioner shall adopt rules |
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prescribing the form and manner for submission of the written |
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verification required under Subsection (a). |
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SECTION 2. This Act takes effect September 1, 2024. |