An Act To Improve Accountability of Opioid Manufacturers
Maine Legislature, Session 129, LD 0793
Committee: Judiciary
Sponsors: JACKSON, MADIGAN, CLAXTON, GRATWICK, LIBBY, VITELLI, BAILEY, HYMANSON

Legislative Document
No. 793
S.P. 237
In Senate, February 12, 2019
An Act To Improve Accountability of Opioid Manufacturers
Reference to the Committee on Judiciary suggested and ordered printed.
DAREK M. GRANT
Secretary of the Senate
Presented by President JACKSON of Aroostook.
Cosponsored by Representative MADIGAN of Waterville and
Senators: CLAXTON of Androscoggin, GRATWICK of Penobscot, LIBBY of Androscoggin, 
VITELLI of Sagadahoc, Representatives: BAILEY of Saco, HYMANSON of York.
Be it enacted by the People of the State of Maine as follows:
Sec. 1.  5 MRSA c. 525 is enacted to read:
CHAPTER 525
OPIOID CRISIS ACCOUNTABILITY ACT
§20101.  Short title
This chapter may be known and cited as "the Opioid Crisis Accountability Act."
§20102.  Definitions
As used in this chapter, unless the context otherwise indicates, the following terms 
have the following meanings.
1.  Abuse liability.  "Abuse liability" means the potential of an opioid medication to 
result in physical or psychological dependence on the opioid medication that is likely to 
lead to substance use disorder as described in section 20003, subsection 17-A.
2.  Commissioner.  "Commissioner" means the Commissioner of Health and Human 
Services.
3.  Department.  "Department" means the Department of Health and Human 
Services.
4.  Opioid medication manufacturer or distributor.  "Opioid medication 
manufacturer or distributor" means a business operating in this State that manufactures or 
distributes opioid medication to another person or business in this State.
§20103.  Illegal marketing or distribution of opioid medication prohibited
1.  Prohibited acts.  An opioid medication manufacturer or distributor may not:
A.  Falsely represent in this State, by means of distributing marketing materials or 
otherwise advertising, that an opioid medication:
(1)  Does not have abuse liability; or
(2)  Has a lower abuse liability than another opioid medication;
B.  Distribute a quantity of opioid medications in this State that is not medically 
reasonable; or
C.  Fail to report to the commissioner pursuant to section 20104 an order or pattern of 
orders for the distribution of opioid medication in this State that is not medically 
reasonable.
§20104.  Reporting required
An opioid medication manufacturer or distributor shall report to the commissioner an 
order or pattern of orders for the distribution of opioid medication in this State that is not 
medically reasonable.
§20105.  Medically reasonable standard
The department shall establish by rule the medically reasonable standard applicable 
to section 20103, subsection 1, paragraphs B and C.  In adopting the standard, the 
department shall consult data from the automated reports and consolidated ordering 
system of the United States Department of Justice.
§20106.  Investigation
The Attorney General, upon the Attorney General's own initiative or upon petition of 
the commissioner or of 50 or more residents of the State, shall investigate suspected 
violations of this chapter.
§20107.  Violations
1.  Penalty for individual.  Notwithstanding any other law to the contrary, a person 
employed by an opioid medication manufacturer or distributor who directly and 
knowingly violates section 20103 or 20104 commits a civil violation for which a fine of 
not more than the total of the following may be adjudged:
A.  The amount of the person's salary from the period in which the person was in 
violation; and
B.  The amount by which the person's stock or other certificates of ownership interest 
in the opioid medication manufacturer or distributor increased in value during the 
period in which the person was in violation.
2.  Penalty for business.  An opioid medication manufacturer or distributor that 
knowingly violates section 20103 or 20104 commits a civil violation for which a fine of 
not more than 25% of the total profit of the opioid medication manufacturer or distributor 
from the sale of opioid medication in the United States during the period in which the 
opioid medication manufacturer or distributor was in violation.
§20108.  Fund
1.  Fund established.  The Opioid Reimbursement Fund, referred to in this section as 
"the fund," is established as a nonlapsing fund in the department for the purposes 
specified in this section.
2.  Source of funds.  The State Controller shall credit to the fund any penalties and 
fines assessed for violations of this chapter.
3.  Uses of the fund.  The fund may be used for activities of the department relating 
to substance use disorder pursuant to chapter 521.
§20109.  Rules
The department may adopt rules necessary to implement this chapter. Rules adopted 
pursuant to this section are routine technical rules as defined in Title 5, chapter 375, 
subchapter 2-A.
§20110.  Retroactivity
This Act applies retroactively to January 1, 1985.
SUMMARY
This bill prohibits opioid medication manufacturers and distributors from falsely 
advertising that an opioid medication does not have abuse liability or has a lower abuse 
liability than another opioid medication; distributing a quantity of opioid medications that 
is not medically reasonable; or failing to report orders that are not medically reasonable.  
It establishes a civil violation and authorizes the Attorney General to investigate 
violations.  It creates a fund into which the penalties and fees must be paid.  This 
legislation applies retroactively to January 1, 1985.