An Act To Protect Maine Consumers from Unsupported Price Increases on Prescription Medicines by Creating an Independent Review Process
Maine Legislature, Session 130, LD 0675
Committee: Health Coverage, Insurance and Financial Services
Sponsors: CLAXTON, BRENNER, CURRY, JACKSON, LUCHINI, MAXMIN, RAFFERTY, VITELLI

Legislative Document
No. 675
S.P. 262
In Senate, March 4, 2021
An Act To Protect Maine Consumers from Unsupported Price 
Increases on Prescription Medicines by Creating an Independent 
Review Process
Received by the Secretary of the Senate on March 2, 2021.  Referred to the Committee on 
Health Coverage, Insurance and Financial Services pursuant to Joint Rule 308.2 and ordered 
printed.
DAREK M. GRANT
Secretary of the Senate
Presented by Senator CLAXTON of Androscoggin.
Cosponsored by Senators: BRENNER of Cumberland, CURRY of Waldo, President 
JACKSON of Aroostook, LUCHINI of Hancock, MAXMIN of Lincoln, RAFFERTY of York, 
VITELLI of Sagadahoc.
Be it enacted by the People of the State of Maine as follows:
Sec. 1.  5 MRSA c. 166 is enacted to read:
CHAPTER 166
PROTECTION OF CONSUMERS FROM UNSUPPORTED PRESCRIPTION 
DRUG PRICE INCREASES
§2035. Definitions
As used in this chapter, unless the context otherwise indicates, the following terms 
have the following meanings.
1. Consumer Price Index.  "Consumer Price Index" means the Consumer Price Index, 
Annual Average, for All Urban Consumers, CPI-U: U.S. City Average, All items, reported 
by the United States Department of Labor, Bureau of Labor Statistics, or its successor or, 
if the index is discontinued, an equivalent index reported by a federal authority or, if no 
such index is reported, "Consumer Price Index" means a comparable index chosen by the 
Bureau of Labor Statistics.
2. Identified prescription drug.  "Identified prescription drug" means a prescription 
drug that has at any time been identified as having an unsupported price increase.
3. Prescription drug.  "Prescription drug" has the same meaning as in Title 32, section 
13702-A, subsection 30.
4. Prescription drug manufacturer.  "Prescription drug manufacturer" means a 
business operating in this State that manufactures prescription drugs for sale to another 
person or business in this State.
5. Superintendent.  "Superintendent" means the Superintendent of Insurance within 
the Department of Professional and Financial Regulation. 
6. Unsupported price increase.  "Unsupported price increase" means an increase in 
price for a prescription drug for which there was no, or inadequate, new clinical evidence 
to support the price increase, as demonstrated by the analyses of prescription drugs 
prepared annually by the Institute for Clinical and Economic Review, or successor 
organization, and published in the institute's annual report on unsupported price increases.
7. Wholesale acquisition cost.  "Wholesale acquisition cost" has the meaning stated 
in 42 United States Code, Section 1395w-3a.
§2036. Sales of identified prescription drugs prohibited
1. Sales of identified prescription drugs prohibited; penalty.  A prescription drug 
manufacturer responsible for the sale of any identified prescription drug in this State 
commits a civil violation for which a fine must be adjudged as provided in this section. 
A.  The fine is assessed on the sales within the State of identified prescription drugs. 
B. The fine in any calendar year is equal to 80% of the difference between the revenue 
generated by sales within the State of the identified prescription drugs and the revenue 
that would have been generated if the prescription drug manufacturer had maintained 
the wholesale acquisition cost from the previous calendar year, adjusted for inflation 
using the Consumer Price Index.
C.  In order for the fine to be assessed, a prescription drug manufacturer must have at 
least $250,000 in total annual sales within the State in the calendar year for which the 
fine is assessed.
D. Within 60 days of the publication of the annual report on unsupported price 
increases by the Institute for Clinical and Economic Review, or successor organization, 
the State Tax Assessor shall identify the prescription drug manufacturers of identified 
prescription drugs. The State Tax Assessor shall notify each prescription drug 
manufacturer that sales within the State of identified prescription drugs are subject to 
the fine described in this section for a period of 2 calendar years following the identified 
prescription drug's appearance in the annual report on unsupported price increases by 
the Institute for Clinical and Economic Review, or successor organization.
E. A prescription drug manufacturer shall pay any fine adjudged under this section 
annually. Any manufacturer notified by the State Tax Assessor pursuant to paragraph 
D shall submit the information required by paragraph F on a form prescribed and 
furnished by the State Tax Assessor and pay the penalty by April 15th for the previous 
calendar year.
F. A prescription drug manufacturer notified by the State Tax Assessor pursuant to 
paragraph D shall provide, at a minimum, the following information to the State Tax 
Assessor: 
(1) The total amount of sales of the identified prescription drug within the State;
(2) The total number of units sold of the identified prescription drug within the 
State; 
(3) The wholesale acquisition cost of the identified prescription drug during the tax 
period and any changes in the wholesale acquisition cost during the calendar year; 
(4) The wholesale acquisition cost of the identified prescription drug during the 
previous calendar year; 
(5) A calculation of the fine owed; and
(6) Any other information that the State Tax Assessor determines is necessary to 
calculate the correct amount of the fine owed.
G. The failure by any prescription drug manufacturer to file the form required by 
paragraph E results in an additional fine of 10% of the fine calculated pursuant to 
paragraph B or $50,000, whichever is greater.
2. Fund established.  The Unsupported Prescription Drug Price Increases Fund, 
referred to in this section as "the fund," is established as a nonlapsing fund in the 
Department of Professional and Financial Regulation, Bureau of Insurance for the purposes 
specified in this subsection. The State Controller shall credit to the fund any fines assessed 
for violations of this chapter payable pursuant to this section. The fund must be used by the 
superintendent to offset costs to consumers. The superintendent may work in cooperation 
with other state agencies to determine the most effective method of optimizing the 
consumer benefit.
3. Administrative costs.  Upon request from the State Tax Assessor, the 
superintendent may transfer money available in the fund to the State Tax Assessor for the 
administrative costs of performing the duty required by subsection 1, paragraph D. The 
superintendent may grant a request only upon finding that there will be no significant 
negative impact on the availability of funds to meet the requirements of subsection 2. 
4. Annual report.  Beginning June 1, 2023 and annually thereafter, the superintendent 
shall submit a report to the joint standing committee of the Legislature having jurisdiction 
over prescription drug matters that describes the amount of revenue from fines paid in 
accordance with subsection 1, segregated by manufacturer and identified prescription drug; 
the current amount available to the superintendent for the purposes described in subsection 
2; how the fine revenue has been used to benefit consumers pursuant to subsection 2; and 
any funds made available to the State Tax Assessor for administrative costs pursuant to 
subsection 3.
§2037. Prohibition on withdrawal of identified prescription drugs for sale
1. Withdrawal from sale prohibited.  It is a violation of this chapter for any 
prescription drug manufacturer or distributor of an identified prescription drug to withdraw 
that prescription drug from sale or distribution within this State for the purpose of avoiding 
the fine set forth in section 2036.
2. Notice required.  A prescription drug manufacturer who intends to withdraw an 
identified prescription drug from sale or distribution within the State must provide 180 
days' prior notice to the Attorney General of the withdrawal in order to avoid violation of 
section 2036, subsection 1. 
3. Penalty.  The Attorney General shall assess a penalty of $500,000 on any entity, 
including any manufacturer or distributor of an identified prescription drug, that it 
determines has withdrawn an identified prescription drug from sale or distribution in this 
State in violation of this section.
Sec. 2.  Legislative findings; impact of price increases for prescription 
drugs.  In order to protect the safety, health and economic well-being of the residents of 
this State by guarding them from the negative and harmful impact of unsupported price 
increases for prescription drugs, the enactment of this Act is necessary and the Legislature 
finds that:
1. Access to prescription drugs is necessary for the residents of this State to maintain 
or acquire good health;
2. Unsupported price increases negatively impact the ability of residents of this State 
to obtain prescription drugs and thereby endanger the health and safety of residents of this 
State to maintain or acquire good health;
3. Unsupported price increases for prescription drugs threaten the economic well-being 
of residents of this State and endanger their ability to pay for other necessary and essential 
goods and services including housing, food and utilities;
4.  Unsupported price increases for prescription drugs contribute significantly to a 
dramatic and unsustainable rise in health care costs and health insurance that threatens the 
overall ability of residents of this State to obtain health coverage and maintain or acquire 
good health;
5. Unsupported price increases for prescription drugs contribute significantly to rising 
state costs for health care provided and paid for through state-funded medical assistance 
programs for residents of this State who are older, living with disabilities or have low 
incomes and health insurance programs for public employees, including employees of the 
State, municipalities and counties, school districts and institutions of higher education, and 
retirees whose health care costs are funded by public programs, thereby threatening the 
ability of the State to fund those programs adequately and further threatening the ability of 
the State to fund other programs necessary for the public good and safety, such as public 
education and public safety; and
6.  Analysis of the increase in prices charged by manufacturers of prescription drugs 
demonstrates that many price increases for high-cost and high-volume prescription drugs 
are not supported by adequate evidence of improved clinical benefit or by significant 
increase in costs to the manufacturer related to the production or sale of the product.
SUMMARY
This bill makes prescription drug manufacturers subject to fines for the sale of 
prescription drugs in this State identified as having an unsupported price increase. The 
determination of what constitutes an unsupported price increase for a prescription drug is 
based on whether there was no, or inadequate, new clinical evidence to support the price 
increase, as demonstrated by the analyses of prescription drugs prepared annually by the 
Institute for Clinical and Economic Review, or successor organization.