Rhode Island HB 7041: AN ACT RELATING TO BUSINESSES AND PROFESSIONS -- THE PRESCRIPTION DRUG SALES REPRESENTATIVE DISCLOSURE ACT

Bill Text

2024 -- H 7041 AS AMENDED
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LC003801
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S T A T E O F R H O D E I S L A N D
IN GENERAL ASSEMBLY
JANUARY SESSION, A.D. 2024
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A N A C T
RELATING TO BUSINESSES AND PROFESSIONS -- THE PRESCRIPTION DRUG SALES
REPRESENTATIVE DISCLOSURE ACT
Introduced By: Representatives Potter, Morales, Tanzi, Giraldo, Kislak, Donovan, and
Cruz
Date Introduced: January 05, 2024
Referred To: House Health & Human Services

It is enacted by the General Assembly as follows:
SECTION 1. Legislative findings and declaration of purpose. The general assembly hereby 1
finds and declares that: 2
(1) Containing health care costs requires containing prescription drug costs. The costs of 3
prescription drugs have been increasing dramatically. To contain prescription drug costs, it is 4
essential to understand the drivers of those costs, including increases in prescriptions and changes 5
in prescription patterns from low-cost to high-cost drugs. 6
(2) Drug companies employ pharmaceutical sales representatives to increase sales by 7
persuading prescribers to prescribe certain drugs. Sales representatives may provide education to 8
the prescriber, but often also include inducements in the form of gifts and drug samples. 9
(3) Drug sales representatives often have access to physician prescription tracking data. 10
(4) The state has an interest in requiring disclosures and regulating the practice of drug 11
sales representatives. 12
SECTION 2. Title 5 of the General Laws entitled "BUSINESSES AND PROFESSIONS" 13
is hereby amended by adding thereto the following chapter: 14
CHAPTER 19.3 15
THE PRESCRIPTION DRUG SALES REPRESENTATIVE DISCLOSURE ACT 16
5-19.3-1. Short title. 17
This chapter shall be known and may be cited as "The Prescription Drug Sales 18

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Representative Disclosure Act". 1
5-19.3-2. Definitions. 2
As used in this chapter, the following words and terms shall have the following meanings: 3
(1) "Department" means the department of business regulation. 4
(2) "Director" means the director of the department of business regulation, or designee. 5
(3) "Manufacturer" means a pharmaceutical, biological product, or medical device 6
manufacturer or any other person who is engaged in the production, preparation, propagation, 7
compounding, processing, marketing, or packaging of prescribed products. The term does not 8
include a wholesale distributor, a retailer, or a pharmacist. The term also does not include a 9
manufacturer whose only prescribed products are classified as Class I by the U.S. Food and Drug 10
Administration, are exempt from pre-market notification under Section 510(k) of the federal Food, 11
Drug and Cosmetic Act, and are sold over-the-counter without a prescription. 12
(4) "Medical facility" means any freestanding emergency care facility, healthcare facility, 13
physician or podiatry ambulatory-surgery center, or other similar entity licensed by the state. 14
(5) "Pharmaceutical sales representative" means a person who markets prescription drugs 15
to providers of health care licensed, certified or registered in this state, pharmacies or employees 16
thereof, operators or employees of medical facilities or persons licensed or certified by the state. 17
(6) "Prescription drug" means a drug as defined in 21 U.S.C. § 321. 18
(7) "Provider of health care" means any person licensed in this state to administer or 19
prescribe a prescription drug. 20
5-19.3-3. Pharmaceutical manufacturer and sales representative registration, 21
disclosure, and transparency report. 22
(a) A manufacturer of a prescription drug shall provide to the department a list of each 23
pharmaceutical sales representative who markets prescription drugs on behalf of the manufacturer 24
to providers of health care in this state, pharmacies or employees thereof, or operators or employees 25
of medical facilities or persons licensed in this state. 26
(1) The manufacturer shall inform the department by any means acceptable to the 27
department of a change in the manufacturer's list within sixty (60) days of the change. Failure to 28
timely inform the department of a change may result in a penalty to be determined by the 29
department. 30
(2) The manufacturer shall refile or update the list annually. 31
(b) The department shall provide electronic access to the most recent list provided by each 32
manufacturer pursuant to subsection (a) of this section, to each provider of health care licensed, 33
certified or registered in this state, operator of a pharmacy, and operator of a medical facility, or 34

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person licensed or certified under the provisions of title 5 for the purposes of ensuring compliance 1
with the requirements of subsection (c) of this section. The department shall also provide electronic 2
access to the information to the department of health and public access via the department's website. 3
This subsection must not be construed to impose any duty on a provider of health care, operator