87R6968 JG-D
By: Bettencourt S.B. No. 1820
A BILL TO BE ENTITLED
AN ACT
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.