Rhode Island 2023 Regular Session

Rhode Island Senate Bill S0573 Compare Versions

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

Old	New	Differences
1	1
2	2
3	3
4	4
5	5	2023 -- S 0573
6	6	========
7	7	LC001818
8	8	========
9	9	S TATE OF RHODE IS LAND
10	10	IN GENERAL ASSEMBLY
11	11	JANUARY SESSION, A.D. 2023
12	12	____________
13	13
14	14	A N A C T
15	15	RELATING TO BUSINESSES AND PROFESSIONS -- THE PRESCRIPTION DRUG SALES
16	16	REPRESENTATIVE DISCLOSURE ACT
17	17	Introduced By: Senators Valverde, Miller, Lawson, Lauria, DiMario, DiPalma, Murray,
18	18	and Kallman
19	19	Date Introduced: March 07, 2023
20	20	Referred To: Senate Health & Human Services
21	21
22	22
23	23	It is enacted by the General Assembly as follows:
24	24	SECTION 1. Legislative findings and declaration of purpose. The general assembly hereby 1
25	25	finds and declares that: 2
26	26	(1) Containing health care costs requires containing prescription drug costs. The costs of 3
27	27	prescription drugs have been increasing dramatically. To contain prescription drug costs, it is 4
28	28	essential to understand the drivers of those costs, including increases in prescriptions and changes 5
29	29	in prescription patterns from low-cost to high-cost drugs. 6
30	30	(2) Drug companies employ pharmaceutical sales representatives to increase sales by 7
31	31	persuading prescribers to prescribe certain drugs. Sales representatives may provide education to 8
32	32	the prescriber, but often also include inducements in the form of gifts and drug samples. 9
33	33	(3) Drug sales representatives often have access to physician prescription tracking data. 10
34	34	(4) The state has an interest in requiring disclosures and regulating the practice of drug 11
35	35	sales representatives. 12
36	36	SECTION 2. Title 5 of the General Laws entitled “Businesses and Professions” is hereby 13
37	37	amended by adding thereto the following chapter: 14
38	38	CHAPTER 19.3 15
39	39	THE PRESCRIPTION DRUG SALES REPRESENTATIVE DISCLOSURE ACT 16
40	40	5-19.3-1. Short title. 17
41	41	This chapter shall be known and may be cited as “The Prescription Drug Sales 18
42	42
43	43
44	44	LC001818 - Page 2 of 5
45	45	Representative Disclosure Act”. 1
46	46	5-19.3-2. Definitions. 2
47	47	As used in this chapter, the following words and terms shall have the following meanings: 3
48	48	(1) “Department” means the department of business regulation. 4
49	49	(2) “Director” means the director of the department of business regulation, or designee. 5
50	50	(3) “Manufacturer” means a pharmaceutical, biological product, or medical device 6
51	51	manufacturer or any other person who is engaged in the production, preparation, propagation, 7
52	52	compounding, processing, marketing, packaging, repacking, distributing, or labeling of prescribed 8
53	53	products. The term does not include a wholesale distributor of biological products, a retailer, or a 9
54	54	pharmacist. The term also does not include a manufacturer whose only prescribed products are 10
55	55	classified as Class I by the U.S. Food and Drug Administration, are exempt from pre-market 11
56	56	notification under Section 510(k) of the federal Food, Drug and Cosmetic Act, and are sold over-12
57	57	the-counter without a prescription. 13
58	58	(4) “Medical facility” means any freestanding emergency care facility, healthcare facility, 14
59	59	physician or podiatry ambulatory-surgery center, or other similar entity licensed by the state. 15
60	60	(5) “Pharmaceutical sales representative” means a person who markets prescription drugs 16
61	61	to providers of health care licensed, certified or registered in this state, pharmacies or employees 17
62	62	thereof, operators or employees of medical facilities or persons licensed or certified by the state. 18
63	63	(6) “Prescription drug” means a drug as defined in 21 U.S.C. § 321. 19
64	64	(7) “Provider of health care” means any person licensed in this state to administer or 20
65	65	prescribe a prescription drug. 21
66	66	5-19.3-3. Pharmaceutical manufacturer and sales representative registration, 22
67	67	disclosure, and transparency report. 23
68	68	(a) A manufacturer of a prescription drug shall provide to the department a list of each 24
69	69	pharmaceutical sales representative who markets prescription drugs on behalf of the manufacturer 25
70	70	to providers of health care in this state, pharmacies or employees thereof, or operators or employees 26
71	71	of medical facilities or persons licensed in this state. 27
72	72	(1) The manufacturer shall inform the department by any means acceptable to the 28
73	73	department of a change in the manufacturer’s list within sixty (60) days of the change. Failure to 29
74	74	timely inform the department of a change may result in a penalty to be determined by the 30
75	75	department. 31
76	76	(2) The manufacturer shall refile or update the list annually. 32
77	77	(b) The department shall provide electronic access to the most recent list provided by each 33
78	78	manufacturer pursuant to subsection (a) of this section, to each provider of health care licensed, 34
79	79
80	80
81	81	LC001818 - Page 3 of 5
82	82	certified or registered in this state, operator of a pharmacy, and operator of a medical facility, or 1
83	83	person licensed or certified under the provisions of title 5 for the purposes of ensuring compliance 2
84	84	with the requirements of subsection (c) of this section. The department shall also provide electronic 3
85	85	access to the information to the department of health and public access via the department’s 4
86	86	website. This subsection must not be construed to impose any duty on a provider of health care, 5
87	87	operator of a pharmacy, or operator of a medical facility or person licensed or certified under the 6
88	88	provisions of title 5 to ensure such compliance. 7
89	89	(c) A person who is not included on a current list submitted pursuant to subsection (a) of 8
90	90	this section, shall not market prescription drugs on behalf of a manufacturer to any provider of 9
91	91	health care licensed, certified or registered in this state, pharmacy or employee thereof, operator or 10
92	92	employee of a medical facility or person licensed or certified under the provisions of title 5. 11
93	93	(d) On or before March 1 of each year, each person who was included on a list of 12
94	94	pharmaceutical sales representatives submitted pursuant to subsection (a) of this section, at any 13
95	95	time during the immediately preceding calendar year shall submit to the department a report, which 14
96	96	shall include, for the immediately preceding calendar year: 15
97	97	(1) A list of providers of health care, pharmacies and employees thereof, and operators and 16
98	98	employees of medical facilities and persons licensed or certified under the provisions of title 5 to 17
99	99	whom the pharmaceutical sales representative provided: 18
100	100	(i) Any type of compensation, gift, or thing of value, with a value that exceeds one hundred 19
101	101	dollars ($100); or 20
102	102	(ii) Total compensation, gift, or thing of value, with a value that exceeds two hundred fifty 21
103	103	dollars ($250) in the aggregate; and 22
104	104	(2) The name and manufacturer of each prescription drug for which the pharmaceutical 23
105	105	sales representative provided a free sample to a provider of health care licensed, certified or 24
106	106	registered in this state, pharmacy or employee thereof, or operator or employee of a medical facility 25
107	107	or person licensed or certified under the provisions of title 5. 26
108	108	(e) The department shall analyze annually the information submitted pursuant to subsection 27
109	109	(d) of this section, and compile a report on the activities of pharmaceutical sales representatives in 28
110	110	this state. On or before June 1 of each year, the department shall: 29
111	111	(1) Post the report on the website maintained by the department; and 30
112	112	(2) Submit the report to the governor, the director of the department of health, the 31
113	113	commissioner of the office of health insurance, and to the speaker of the house and the senate 32
114	114	president. 33
115	115	5-19.3-4. Fees and penalties. 34
116	116
117	117
118	118	LC001818 - Page 4 of 5
119	119	(a) A fee in the amount of fifty-five dollars ($55.00) annually shall be charged by the 1
120	120	director from each manufacturer, per each pharmaceutical sales representative listed by the 2
121	121	manufacturer. All revenue collected pursuant to this chapter shall be deposited as restricted receipts 3
122	122	available to the department as described in § 42-14-9. 4
123	123	(b) The attorney general may bring an action in the civil division of the superior court, 5
124	124	Providence county for injunctive relief, costs, and attorneys’ fees, and to impose on a manufacturer 6
125	125	that fails to provide the information required by this chapter a civil penalty of no more than ten 7
126	126	thousand dollars ($10,000) per violation. Each unlawful failure to provide information shall 8
127	127	constitute a separate violation. In any action brought pursuant to this section, the attorney general 9
128	128	shall have the same authority to investigate and to obtain remedies as if the action were brought 10
129	129	under chapter 13.1 of title 6 ("deceptive trade practices"). 11
130	130	SECTION 3. This act shall take effect on January 1, 2024. 12
131	131	========
132	132	LC001818
133	133	========
134	134
135	135
136	136	LC001818 - Page 5 of 5
137	137	EXPLANATION
138	138	BY THE LEGISLATIVE COUNCIL
139	139	OF
140	140	A N A C T
141	141	RELATING TO BUSINESSES AND PROFESSIONS -- THE PRESCRIPTION DRUG SALES
142	142	REPRESENTATIVE DISCLOSURE ACT
143	143	***
144	144	This act would require prescription drug manufacturers to file a detailed, updated list of 1
145	145	each pharmaceutical sales representative engaged by the manufacturer and to pay an annual fee for 2
146	146	each name listed with the department of business regulation. Failure to comply would result in civil 3
147	147	penalties. 4
148	148	This act would take effect on January 1, 2024. 5
149	149	========
150	150	LC001818
151	151	========
152	152