Texas 2009 - 81st Regular

Texas Senate Bill SB553 Compare Versions

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1	1	2009S0006-1 10/24/08
2	2	By: Lucio S.B. No. 553
3	3
4	4
5	5	A BILL TO BE ENTITLED
6	6	AN ACT
7	7	relating to the disclosure of certain economic benefits provided by
8	8	manufacturers or repackagers of prescription drugs; providing
9	9	penalties.
10	10	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
11	11	SECTION 1. Chapter 431, Health and Safety Code, is amended
12	12	by adding Subchapter O to read as follows:
13	13	SUBCHAPTER O. PRESCRIPTION DRUG MARKETING
14	14	Sec. 431.451. DEFINITIONS. In this subchapter:
15	15	(1) "Pharmaceutical marketer" means a person who,
16	16	while employed by or under contract to represent a manufacturer or
17	17	repackager, engages in pharmaceutical detailing, promotional
18	18	activity, or other marketing of prescription drugs in this state to
19	19	a physician, hospital, nursing home, pharmacist, health benefit
20	20	plan administrator, or other person authorized by law to dispense
21	21	or prescribe prescription drugs in this state.
22	22	(2) "Repackager" has the meaning assigned by Section
23	23	431.401.
24	24	Sec. 431.452. ANNUAL REPORT; DISCLOSURE OF CERTAIN ECONOMIC
25	25	BENEFITS. (a) Not later than January 1 of each year, a
26	26	manufacturer or repackager that sells or repackages prescription
27	27	drugs in this state shall submit to the department the name and
28	28	address of the individual responsible for the manufacturer's or
29	29	repackager's compliance with this section.
30	30	(b) Not later than February 1 of each year, a manufacturer
31	31	or repackager that sells or repackages prescription drugs in this
32	32	state shall submit to the department a report that discloses any
33	33	gift, fee, payment, subsidy, or other economic benefit received by
34	34	a physician, physician's office, hospital, nursing home,
35	35	pharmacist, health benefit plan administrator, or other person
36	36	authorized by law to dispense or prescribe prescription drugs in
37	37	this state in connection with detailing, promotional, or marketing
38	38	activities of the manufacturer or repackager, directly or through
39	39	its pharmaceutical marketers.
40	40	(c) The report required under Subsection (b) must cover the
41	41	preceding calendar year and must be submitted on a form, including
42	42	any electronic form, prescribed by the department. The report must
43	43	include:
44	44	(1) the name and address of each recipient of an
45	45	economic benefit;
46	46	(2) the value and a description of the economic
47	47	benefit; and
48	48	(3) the date of receipt of the economic benefit.
49	49	(d) The department shall make available to the public on
50	50	request a report submitted under this section.
51	51	(e) Not later than March 1 of each year, the department
52	52	shall make all reports submitted under this section available on
53	53	the department's Internet website.
54	54	Sec. 431.453. EXEMPTIONS. The following economic benefits
55	55	are exempt from disclosure under Section 431.452:
56	56	(1) a gift, fee, payment, subsidy, or other economic
57	57	benefit with a fair market value that is less than $75;
58	58	(2) free samples of prescription drugs intended for
59	59	distribution to patients;
60	60	(3) payment of reasonable compensation and
61	61	reimbursement of expenses in connection with bona fide clinical
62	62	trials conducted in relation to a research study designed to answer
63	63	specific questions about vaccines, new therapies, or new ways of
64	64	using known treatments;
65	65	(4) a scholarship or other support for a medical
66	66	student, resident, or fellow to attend a bona fide educational,
67	67	scientific, or policy-making conference of an established
68	68	professional association if the recipient of the scholarship or
69	69	other support is selected by the association; and
70	70	(5) a grant or other support for the development,
71	71	production, or presentation of a bona fide educational, scientific,
72	72	or policy-making program or conference of an established
73	73	professional association if the professional association
74	74	independently selects, develops, produces, or presents the
75	75	educational, scientific, or policy-making program or conference.
76	76	Sec. 431.454. PENALTIES; INJUNCTION. (a) The
77	77	commissioner may, in accordance with the procedures applicable to
78	78	administrative penalties assessed under Subchapter C, assess an
79	79	administrative penalty against a person who does not file a report
80	80	required under this subchapter.
81	81	(b) The attorney general may bring an action:
82	82	(1) for injunctive relief to compel a person to file a
83	83	report required under this subchapter; and
84	84	(2) to impose a civil penalty of not more than $10,000
85	85	for a failure to file a report required under this subchapter.
86	86	(c) Each failure to file a report required under this
87	87	subchapter constitutes a separate violation.
88	88	(d) The court may award to the attorney general reasonable
89	89	court costs and attorney's fees in connection with an action
90	90	brought under Subsection (b).
91	91	SECTION 2. (a) Not later than January 1, 2010, the
92	92	executive commissioner of the Health and Human Services Commission
93	93	shall adopt the rules and procedures necessary to implement
94	94	Subchapter O, Chapter 431, Health and Safety Code, as added by this
95	95	Act, including rules defining bona fide clinical trials and bona
96	96	fide programs and conferences under Subdivisions (3), (4), and (5),
97	97	Section 431.453, Health and Safety Code, as added by this Act.
98	98	(b) Not later than January 1, 2010, the Department of State
99	99	Health Services shall develop the form required by Section 431.452,
100	100	Health and Safety Code, as added by this Act.
101	101	(c) Notwithstanding Section 431.452, Health and Safety
102	102	Code, as added by this Act, a manufacturer or repackager of
103	103	prescription drugs is not required to submit the report required by
104	104	that section before February 1, 2011.
105	105	SECTION 3. (a) Except as provided by Subsection (b) of
106	106	this section, this Act takes effect September 1, 2009.
107	107	(b) Section 431.454, Health and Safety Code, as added by
108	108	this Act, takes effect January 1, 2011.