Texas 2021 - 87th Regular

Texas Senate Bill SB1820 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1	87R6968 JG-D
2	2	By: Bettencourt S.B. No. 1820
3	3
4	4
5	5	A BILL TO BE ENTITLED
6	6	AN ACT
7	7	relating to the promotion of off-label uses of certain drugs,
8	8	biological products, and devices.
9	9	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
10	10	SECTION 1. Subtitle A, Title 6, Health and Safety Code, is
11	11	amended by adding Chapter 444 to read as follows:
12	12	CHAPTER 444. OFF-LABEL USE OF CERTAIN DRUGS, BIOLOGICAL PRODUCTS,
13	13	AND DEVICES
14	14	Sec. 444.001. DEFINITIONS. In this chapter:
15	15	(1) "Health care provider" means a person other than a
16	16	physician who is licensed, certified, or otherwise authorized by
17	17	the laws of this state to dispense or prescribe a prescription drug
18	18	in the ordinary course of business or practice of a profession.
19	19	(2) "Off-label use" means the use of a drug,
20	20	biological product, or device approved for use by the United States
21	21	Food and Drug Administration in a manner other than the use for
22	22	which it is approved by the United States Food and Drug
23	23	Administration.
24	24	(3) "Physician" means a person licensed to practice
25	25	medicine in this state.
26	26	Sec. 444.002. PROMOTION OF OFF-LABEL USE OF CERTAIN DRUGS,
27	27	BIOLOGICAL PRODUCTS, OR DEVICES. (a) Notwithstanding other law, a
28	28	pharmaceutical manufacturer or a representative of a
29	29	pharmaceutical manufacturer may promote, in the manufacturer's
30	30	advertising or marketing materials or directly to a physician or
31	31	health care provider, a medically truthful and accurate off-label
32	32	use of a drug, biological product, or device.
33	33	(b) A physician or health care provider may communicate or
34	34	otherwise promote to a patient an off-label use of a drug,
35	35	biological product, or device consistent with the off-label use
36	36	promoted for that drug, product, or device, as applicable, by a
37	37	pharmaceutical manufacturer under Subsection (a).
38	38	Sec. 444.003. DISCIPLINARY ACTION PROHIBITED FOR PROMOTION
39	39	OF OFF-LABEL USE. (a) A pharmaceutical manufacturer or a
40	40	representative of a pharmaceutical manufacturer may not be
41	41	prosecuted or be subject to disciplinary action, including a
42	42	revocation of or refusal to renew a license or certification, for
43	43	promoting an off-label use of a drug, biological product, or device
44	44	under Section 444.002.
45	45	(b) The state regulatory authority of a physician or health
46	46	care provider may not revoke or refuse to renew the license or
47	47	certificate of or otherwise impose a disciplinary action against a
48	48	physician or health care provider who communicates or otherwise
49	49	promotes an off-label use of a drug, biological product, or device
50	50	under Section 444.002.
51	51	Sec. 444.004. HEALTH BENEFIT PLAN COVERAGE FOR OFF-LABEL
52	52	USE NOT REQUIRED. This chapter does not require a health benefit
53	53	plan to provide health benefit coverage for an off-label use of a
54	54	drug, biological product, or device.
55	55	Sec. 444.005. USE OF STATE MONEY FOR CERTAIN PURPOSES
56	56	PROHIBITED. This state or a local governmental entity may not use
57	57	public money to enforce or to cooperate with the federal government
58	58	in enforcing 21 U.S.C. Sections 331 and 335 against a
59	59	pharmaceutical manufacturer or a representative of a
60	60	pharmaceutical manufacturer for promoting an off-label use under
61	61	Section 444.002.
62	62	SECTION 2. Section 444.003, Health and Safety Code, as
63	63	added by this Act, applies to a prosecution or disciplinary action
64	64	initiated or pending on or after the effective date of this Act.
65	65	SECTION 3. This Act takes effect September 1, 2021.