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A BILL TO BE ENTITLED
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AN ACT
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relating to the promotion of off-label uses of certain drugs, |
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biological products, and devices. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Subtitle A, Title 6, Health and Safety Code, is |
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amended by adding Chapter 444 to read as follows: |
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CHAPTER 444. OFF-LABEL USE OF CERTAIN DRUGS, BIOLOGICAL PRODUCTS, |
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AND DEVICES |
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Sec. 444.001. DEFINITIONS. In this chapter: |
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(1) "Health care provider" means a person other than a |
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physician who is licensed, certified, or otherwise authorized by |
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the laws of this state to dispense or prescribe a prescription drug |
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in the ordinary course of business or practice of a profession. |
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(2) "Off-label use" means the use of a drug, |
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biological product, or device approved for use by the United States |
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Food and Drug Administration in a manner other than the use for |
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which it is approved by the United States Food and Drug |
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Administration. |
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(3) "Physician" means a person licensed to practice |
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medicine in this state. |
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(4) "Third-party payer" means an insurance company, |
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health benefit plan sponsor, or entity other than the patient or |
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healthcare provider that pays for medical services provided to a |
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patient. |
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Sec. 444.002. PROMOTION OF OFF-LABEL USE OF CERTAIN DRUGS, |
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BIOLOGICAL PRODUCTS, OR DEVICES. (a) Notwithstanding other law, a |
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pharmaceutical manufacturer or a representative of a |
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pharmaceutical manufacturer may promote, in the manufacturer's |
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advertising or marketing materials or directly to a physician, |
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health care provider, or third-party payer a medically truthful and |
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accurate off-label use of a drug, biological product, or device. |
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(b) A physician or health care provider may communicate or |
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otherwise promote to a patient an off-label use of a drug, |
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biological product, or device consistent with the off-label use |
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promoted for that drug, product, or device, as applicable, by a |
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pharmaceutical manufacturer under Subsection (a). |
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Sec. 444.003. DISCIPLINARY ACTION PROHIBITED FOR PROMOTION |
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OF OFF-LABEL USE. (a) A pharmaceutical manufacturer or a |
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representative of a pharmaceutical manufacturer may not be |
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prosecuted or be subject to disciplinary action, including a |
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revocation of or refusal to renew a license or certification, for |
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promoting an off-label use of a drug, biological product, or device |
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under Section 444.002. |
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(b) The state regulatory authority of a physician or health |
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care provider may not revoke or refuse to renew the license or |
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certificate of or otherwise impose a disciplinary action against a |
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physician or health care provider who communicates or otherwise |
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promotes an off-label use of a drug, biological product, or device |
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under Section 444.002. |
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Sec. 444.004. HEALTH BENEFIT PLAN COVERAGE FOR OFF-LABEL |
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USE NOT REQUIRED. This chapter does not require a health benefit |
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plan to provide health benefit coverage for an off-label use of a |
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drug, biological product, or device. |
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Sec. 444.005. USE OF STATE MONEY FOR CERTAIN PURPOSES |
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PROHIBITED. This state or a local governmental entity may not use |
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public money to enforce or to cooperate with the federal government |
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in enforcing 21 U.S.C. Sections 331 and 335 against a |
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pharmaceutical manufacturer or a representative of a |
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pharmaceutical manufacturer for promoting an off-label use under |
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Section 444.002. |
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SECTION 2. Section 444.003, Health and Safety Code, as |
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added by this Act, applies to a prosecution or disciplinary action |
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initiated or pending on or after the effective date of this Act. |
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SECTION 3. This Act takes effect September 1, 2021. |