87(R) HB 2185 - House Committee Report version - Bill Text

	By:  Parker, Kacal	H.B.  No.  2185

	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.
	(4)    "Third-party payer" means an insurance company,
	health benefit plan sponsor, or entity other than the patient or
	healthcare provider that pays for medical services provided to a
	patient.
	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,
	health care provider, or third-party payer 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.