| 1 | 1 | | 89R3375 EAS-D |
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| 2 | 2 | | By: Hall S.B. No. 90 |
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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 patient access to prescription drugs for off-label use. |
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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. This Act shall be known as the Right to Treat |
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| 12 | 12 | | Act. |
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| 13 | 13 | | SECTION 2. Subtitle C, Title 6, Health and Safety Code, is |
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| 14 | 14 | | amended by adding Chapter 491 to read as follows: |
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| 15 | 15 | | CHAPTER 491. OFF-LABEL USE OF PRESCRIPTION DRUGS |
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| 16 | 16 | | Sec. 491.001. DEFINITIONS. In this chapter: |
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| 17 | 17 | | (1) "Off-label use" means the use of a prescription |
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| 18 | 18 | | drug approved for use by the United States Food and Drug |
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| 19 | 19 | | Administration in a manner other than the approved use. |
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| 20 | 20 | | (2) "Physician" means an individual licensed to |
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| 21 | 21 | | practice medicine in this state. |
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| 22 | 22 | | Sec. 491.002. APPLICABILITY. This chapter applies only to |
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| 23 | 23 | | the prescribing, administering, and dispensing of a prescription |
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| 24 | 24 | | drug the United States Food and Drug Administration has approved |
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| 25 | 25 | | for human use other than an abortion-inducing drug as defined by |
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| 26 | 26 | | Section 171.061. |
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| 27 | 27 | | Sec. 491.003. PROHIBITED STATE INTERFERENCE WITH PATIENT |
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| 28 | 28 | | ACCESS TO OFF-LABEL USE OF PRESCRIPTION DRUG. An official, |
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| 29 | 29 | | employee, or agent of this state may not prohibit or restrict a |
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| 30 | 30 | | physician from prescribing, administering, or dispensing for |
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| 31 | 31 | | off-label use a prescription drug. |
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| 32 | 32 | | Sec. 491.004. NO CAUSE OF ACTION CREATED. This chapter does |
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| 33 | 33 | | not create a private or state cause of action against a manufacturer |
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| 34 | 34 | | of a prescription drug approved by the United States Food and Drug |
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| 35 | 35 | | Administration or against a physician or any other person involved |
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| 36 | 36 | | in the care of a patient for any harm to the patient resulting from |
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| 37 | 37 | | the off-label use of the drug. |
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| 38 | 38 | | Sec. 491.005. PROHIBITED ACTION AGAINST PHYSICIAN'S |
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| 39 | 39 | | LICENSE. Notwithstanding any other law, the Texas Medical Board |
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| 40 | 40 | | may not revoke, fail to renew, suspend, or take any other adverse |
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| 41 | 41 | | action against a physician's license under Subchapter B, Chapter |
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| 42 | 42 | | 164, Occupations Code, based solely on the physician's prescribing, |
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| 43 | 43 | | administering, or dispensing a prescription drug for off-label use |
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| 44 | 44 | | to treat a patient, provided the physician's treatment of the |
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| 45 | 45 | | patient meets the medical standard of care. |
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| 46 | 46 | | SECTION 3. This Act takes effect immediately if it receives |
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| 47 | 47 | | a vote of two-thirds of all the members elected to each house, as |
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| 48 | 48 | | provided by Section 39, Article III, Texas Constitution. If this |
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| 49 | 49 | | Act does not receive the vote necessary for immediate effect, this |
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| 50 | 50 | | Act takes effect September 1, 2025. |
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