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.