Bill Text: TX SB1820 | 2021-2022 | 87th Legislature | Introduced
Bill Title: Relating to the promotion of off-label uses of certain drugs, biological products, and devices.
Spectrum: Partisan Bill (Republican 1-0)
Status: (Introduced - Dead) 2021-04-21 - Left pending in committee [SB1820 Detail]
Download: Texas-2021-SB1820-Introduced.html
87R6968 JG-D | ||
By: Bettencourt | S.B. No. 1820 |
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relating to the promotion of off-label uses of certain drugs, | ||
biological products, and devices. | ||
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: | ||
SECTION 1. Subtitle A, Title 6, Health and Safety Code, is | ||
amended by adding Chapter 444 to read as follows: | ||
CHAPTER 444. OFF-LABEL USE OF CERTAIN DRUGS, BIOLOGICAL PRODUCTS, | ||
AND DEVICES | ||
Sec. 444.001. DEFINITIONS. In this chapter: | ||
(1) "Health care provider" means a person other than a | ||
physician who is licensed, certified, or otherwise authorized by | ||
the laws of this state to dispense or prescribe a prescription drug | ||
in the ordinary course of business or practice of a profession. | ||
(2) "Off-label use" means the use of a drug, | ||
biological product, or device approved for use by the United States | ||
Food and Drug Administration in a manner other than the use for | ||
which it is approved by the United States Food and Drug | ||
Administration. | ||
(3) "Physician" means a person licensed to practice | ||
medicine in this state. | ||
Sec. 444.002. PROMOTION OF OFF-LABEL USE OF CERTAIN DRUGS, | ||
BIOLOGICAL PRODUCTS, OR DEVICES. (a) Notwithstanding other law, a | ||
pharmaceutical manufacturer or a representative of a | ||
pharmaceutical manufacturer may promote, in the manufacturer's | ||
advertising or marketing materials or directly to a physician or | ||
health care provider, a medically truthful and accurate off-label | ||
use of a drug, biological product, or device. | ||
(b) A physician or health care provider may communicate or | ||
otherwise promote to a patient an off-label use of a drug, | ||
biological product, or device consistent with the off-label use | ||
promoted for that drug, product, or device, as applicable, by a | ||
pharmaceutical manufacturer under Subsection (a). | ||
Sec. 444.003. DISCIPLINARY ACTION PROHIBITED FOR PROMOTION | ||
OF OFF-LABEL USE. (a) A pharmaceutical manufacturer or a | ||
representative of a pharmaceutical manufacturer may not be | ||
prosecuted or be subject to disciplinary action, including a | ||
revocation of or refusal to renew a license or certification, for | ||
promoting an off-label use of a drug, biological product, or device | ||
under Section 444.002. | ||
(b) The state regulatory authority of a physician or health | ||
care provider may not revoke or refuse to renew the license or | ||
certificate of or otherwise impose a disciplinary action against a | ||
physician or health care provider who communicates or otherwise | ||
promotes an off-label use of a drug, biological product, or device | ||
under Section 444.002. | ||
Sec. 444.004. HEALTH BENEFIT PLAN COVERAGE FOR OFF-LABEL | ||
USE NOT REQUIRED. This chapter does not require a health benefit | ||
plan to provide health benefit coverage for an off-label use of a | ||
drug, biological product, or device. | ||
Sec. 444.005. USE OF STATE MONEY FOR CERTAIN PURPOSES | ||
PROHIBITED. This state or a local governmental entity may not use | ||
public money to enforce or to cooperate with the federal government | ||
in enforcing 21 U.S.C. Sections 331 and 335 against a | ||
pharmaceutical manufacturer or a representative of a | ||
pharmaceutical manufacturer for promoting an off-label use under | ||
Section 444.002. | ||
SECTION 2. Section 444.003, Health and Safety Code, as | ||
added by this Act, applies to a prosecution or disciplinary action | ||
initiated or pending on or after the effective date of this Act. | ||
SECTION 3. This Act takes effect September 1, 2021. |