Massachusetts 2025-2026 Regular Session

Massachusetts Senate Bill S1583 Compare Versions

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

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1	1	1 of 1
2	2	SENATE DOCKET, NO. 1435 FILED ON: 1/16/2025
3	3	SENATE . . . . . . . . . . . . . . No. 1583
4	4	The Commonwealth of Massachusetts
5	5	_________________
6	6	PRESENTED BY:
7	7	Mark C. Montigny
8	8	_________________
9	9	To the Honorable Senate and House of Representatives of the Commonwealth of Massachusetts in General
10	10	Court assembled:
11	11	The undersigned legislators and/or citizens respectfully petition for the adoption of the accompanying bill:
12	12	An Act to restore integrity in the marketing of pharmaceutical products and medical devices.
13	13	_______________
14	14	PETITION OF:
15	15	NAME:DISTRICT/ADDRESS :Mark C. MontignySecond Bristol and Plymouth 1 of 7
16	16	SENATE DOCKET, NO. 1435 FILED ON: 1/16/2025
17	17	SENATE . . . . . . . . . . . . . . No. 1583
18	18	By Mr. Montigny, a petition (accompanied by bill, Senate, No. 1583) of Mark C. Montigny for
19	19	legislation to restore integrity in the marketing of pharmaceutical products and medical devices.
20	20	Public Health.
21	21	[SIMILAR MATTER FILED IN PREVIOUS SESSION
22	22	SEE SENATE, NO. 1418 OF 2023-2024.]
23	23	The Commonwealth of Massachusetts
24	24	_______________
25	25	In the One Hundred and Ninety-Fourth General Court
26	26	(2025-2026)
27	27	_______________
28	28	An Act to restore integrity in the marketing of pharmaceutical products and medical devices.
29	29	Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority
30	30	of the same, as follows:
31	31	1 SECTION 1. Chapter 111N of the General Laws, as appearing in the 2022 Official
32	32	2Edition, is hereby amended by striking sections 1 through 7 in their entirety and inserting in
33	33	3place thereof the following:
34	34	4 Section 1. As used in this chapter, the following words shall have the following
35	35	5meanings:-
36	36	6 “Department”, the department of public health.
37	37	7 “Education program”, a medical school, teaching hospital, or teaching health center
38	38	8licensed to operate in the commonwealth. 2 of 7
39	39	9 "Gift", a payment, entertainment, meals, travel, honorarium, subscription, advance,
40	40	10services or anything of value, unless consideration of equal or greater value is received and there
41	41	11is an explicit contract with specific deliverables which are not related to marketing and are
42	42	12restricted to medical or scientific issues. “Gift" shall not include anything of value received by
43	43	13inheritance, a gift received from a member of the health care practitioner’s immediate family or
44	44	14from a relative within the third degree of consanguinity of the health care practitioner or of the
45	45	15health care practitioner’s spouse or from the spouse of any such relative, or prescription drugs
46	46	16provided to a health care practitioner solely and exclusively for use by the health care
47	47	17practitioner’s patients.
48	48	18 “Health care practitioner” or “practitioner,” a person who prescribes prescription drugs
49	49	19for any person and is licensed to provide health care or a partnership or corporation made up of
50	50	20those persons or an officer, employee, agent or contractor of that person acting in the course and
51	51	21scope of employment, agency or contract related to or supportive of the provision of health care
52	52	22to individuals.
53	53	23 "Immediate family", a spouse and any dependent children residing in the reporting
54	54	24person's household.
55	55	25 “Medical device”, an instrument, apparatus, implement, machine, contrivance, implant, in
56	56	26vitro reagent, or other similar or related article, including any component, part, or accessory,
57	57	27which is: (1) recognized in the official National Formulary, or the United States Pharmacopeia,
58	58	28or any supplement to them; (2) intended for use in the diagnosis of disease or other conditions, or
59	59	29in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or (3)
60	60	30intended to affect the structure or any function of the body of man or other animals, and which 3 of 7
61	61	31does not achieve its primary intended purposes through chemical action within or on the body of
62	62	32man or other animals and which is not dependent upon being metabolized for the achievement of
63	63	33its primary intended purposes.
64	64	34 "Person", a business, individual, corporation, union, association, firm, partnership,
65	65	35committee, or other organization or group of persons.
66	66	36 “Pharmaceutical or medical device manufacturer agent”, a pharmaceutical or medical
67	67	37device marketer or any other person who for compensation or reward does any act to promote,
68	68	38oppose or influence the prescribing of a particular prescription drug, medical device, or category
69	69	39of prescription drugs or medical devices. The term shall not include a licensed pharmacist,
70	70	40licensed physician or any other licensed health care practitioner with authority to prescribe
71	71	41prescription drugs who is acting within the ordinary scope of the practice for which he is
72	72	42licensed.
73	73	43 “Pharmaceutical or medical device manufacturing company”, any entity that participates
74	74	44in a commonwealth health care program and which is engaged in the production, preparation,
75	75	45propagation, compounding, conversion or processing of prescription drugs or medical devices
76	76	46either directly or indirectly by extraction from substances of natural origin, or independently by
77	77	47means of chemical synthesis or by a combination of extraction and chemical synthesis, or any
78	78	48entity engaged in the packaging, repackaging, labeling, relabeling or distribution of prescription
79	79	49drugs. The term does not include a wholesale drug distributor licensed under section 36A of
80	80	50chapter 112 or a retail pharmacist registered under section 37 of chapter 112.
81	81	51 “Pharmaceutical or medical device marketer”, a person who, while employed by or under
82	82	52contract to represent a pharmaceutical or, medical device manufacturing company that 4 of 7
83	83	53participates in a commonwealth health care program, engages in detailing, promotional activities
84	84	54or other marketing of prescription drugs, or medical devices in the commonwealth to any
85	85	55physician, hospital, nursing home, pharmacist, health benefit plan administrator, any other health
86	86	56care practitioner or any other person authorized to prescribe, dispense, or purchase prescription
87	87	57drugs. The term does not include a wholesale drug distributor licensed under section 36A of
88	88	58chapter 112, a representative of such a distributor who promotes or otherwise markets the
89	89	59services of the wholesale drug distributor in connection with a prescription drug, or a retail
90	90	60pharmacist registered under section 38 of chapter 112 if such person is not engaging in such
91	91	61practices under contract with a manufacturing company.
92	92	62 “Physician”, a person licensed to practice medicine by the board of medicine under
93	93	63section 2 of chapter 112 who prescribes prescription drugs for any person, or the physician’s
94	94	64employees or agents.
95	95	65 “Prescription drugs”, any and all drugs upon which the manufacturer or distributor has
96	96	66placed or is required by federal law and regulations to place the following or a comparable
97	97	67warning: “Caution federal law prohibits dispensing without prescription.”
98	98	68 Section 2. No pharmaceutical or medical device manufacturer agent shall knowingly and
99	99	69willfully offer or give to a health care practitioner, a member of a health care practitioner’s
100	100	70immediate family, a health care practitioner’s employee or agent, a health care facility, an
101	101	71employee or agent of a health care facility, an education program, or an employee or agent of an
102	102	72education program a gift of any value. 5 of 7
103	103	73 Nothing in the section shall prohibit the provision, distribution, dissemination, or receipt
104	104	74of peer reviewed academic, scientific or clinical information. Nothing in this section shall
105	105	75prohibit the purchase of advertising in peer reviewed academic, scientific or clinical journals.
106	106	76 Section 3. (a)(1) By July first of each year, every pharmaceutical or medical device
107	107	77manufacturing company shall disclose to the department the value, nature, purpose, and recipient
108	108	78of any fee, payment, subsidy, or other economic benefit not prohibited in section 2, which is
109	109	79provided by the company, directly or through its agents, to any physician, hospital, nursing
110	110	80home, pharmacist, health benefit plan administrator, education program, health care practitioner
111	111	81or any other person in this commonwealth authorized to prescribe, dispense, or purchase
112	112	82prescription drugs or medical devices. Required disclosures under this section shall include, but
113	113	83are not limited to, any payments made for board memberships, research, or consulting services.
114	114	84For each expenditure, the company must also identify the recipient and the recipient’s address,
115	115	85credentials, institutional affiliation, and state board or DEA numbers.
116	116	86 (2) Each company subject to the provisions of this section also shall disclose to the
117	117	87department the name and address of the individual responsible for the company's compliance
118	118	88with the provisions of this section, or if this information has been previously reported, any
119	119	89changes to the name or address of the individual responsible for the company's compliance with
120	120	90the provisions of this section.
121	121	91 (3) Information disclosed pursuant to this section shall be accompanied by payment of a
122	122	92fee, to be set by the department, to pay the costs of administering these provisions. 6 of 7
123	123	93 (b)(1) Information submitted to the department of public health pursuant to this section
124	124	94shall be a public record except to the extent that it includes information that is protected by state
125	125	95or federal law as a trade secret.
126	126	96 (2) Notwithstanding any other provision of law, the identity of health care practitioners
127	127	97and other recipients of gifts, payments and materials required to be reported in this chapter shall
128	128	98not constitute confidential information or trade secrets protected under this section.
129	129	99 (3) The department shall make all disclosed data publicly available and easily searchable
130	130	100on its website.
131	131	101 (c) The department shall report to the attorney general any payment, entertainment,
132	132	102meals, travel, honorarium, subscription, advance, services or anything of value provided in
133	133	103violation of this chapter, including anything of value provided when consideration of equal or
134	134	104greater value was not received or anything of value provided that was not subject to an explicit
135	135	105contract with specific deliverables which were restricted to medical or scientific issues.
136	136	106 Section 4. The department, in consultation with the board of registration of pharmacy,
137	137	107and board of registration of medicine, shall promulgate regulations requiring the licensing of all
138	138	108pharmaceutical and medical device manufacturer agents. As a prerequisite to such licensing,
139	139	109pharmaceutical and medical device manufacturer agents shall complete such training as may be
140	140	110deemed appropriate by the department. As a prerequisite to the renewal of such license,
141	141	111pharmaceutical and medical device manufacturer agents shall complete continuing education as
142	142	112may be deemed appropriate by the department. The fee for such license shall be determined by
143	143	113the department, in conjunction with the board of registration in pharmacy and the board of
144	144	114registration in medicine at a rate sufficient to provide the administration and enforcement of this 7 of 7
145	145	115chapter. Revenue generated from this fee shall be divided in equal shares, 75 per cent to the
146	146	116department of public health and 25% to the office of attorney general, line item 0810-0000, for
147	147	117the administration of this chapter.
148	148	118 Section 5. This chapter shall be enforced by the attorney general, the district attorney
149	149	119with jurisdiction over a violation, or the department. A person who violates this chapter shall be
150	150	120punished by a fine of not less than $10,000 for each transaction, occurrence or event that violates
151	151	121this chapter.