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