An Act Regarding Generic Drug Pricing
Maine Legislature, Session 128, LD 1280
Committee Amendment CA_A-SA_D_S309 (Senate)

SENATE AMENDMENT" D" to COMMITTEE AMENDMENT "A" to S.P. 432, 
L.D. 1280, Bill, "An Act Regarding Generic Drug Pricing" 
Amend the amendment in section 5 in § 13 800 in the 2nd paragraph in the 2nd line 
(page 1, line 27 in amendment) by striking out the following: "fair market price" and 
inserting the following: 'a price no greater than the wholesale acquisition cost' 
Amend the amendment in section 5 in § 13 800 by inserting after the 2nd paragraph 2 
new paragraphs to read: 
'An eligible product developer that receives a drug at a price no greater than the 
wholesale acquisition cost for that drug pursuant to this section shall charge consumers in 
this State the same price or less for the drug manufactured by that eligible product 
developer. 
As used in this section, "wholesale acquisition cost" means the manufacturer's list 
price for a brand-name drug or a generic drug per person per year or course of treatment 
when sold to wholesalers or direct purchasers in the United States, not including 
discounts or rebates, for the most recent month for which information is available.' 
Amend the amendment by inserting after section 5 the following: 
'Sec. 6. Intent. 
The costs of health care in this State are making health care 
coverage unaffordable for many consumers, increasing health care costs for the State and 
contributing to a health care crisis in this State. Increased competition in the market for 
drugs and biological products lowers prescription drug costs for patients and taxpayers. 
In order for there to be competition in the prescription drug market, developers of generic 
drugs and biosimilar biological products must be able to obtain quantities of the reference 
listed drug or biological product with which the generic drug or biosimilar biological 
product is intended to compete, referred to in this section as "reference samples," for 
purposes of supporting an application for approval by the United States Food and Drug 
Administration. Closed distribution systems are impeding generic and biosimilar product 
developers from obtaining reference samples to conduct necessary testing and otherwise 
meet requirements for approval of generic and biosimilar drugs and subjecting residents 
of this State to monopoly drug prices. This Act promotes competition in the market for 
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drugs and biological products by facilitating access to reference samples. Developers of 
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generic drugs and biosimilar biological products are required to act in accordance with 
SENA TE AMENDMENT 
.. , 
I 
SENATE AMENDMENT "D "to COMMITTEE AMENDMENT "A" to S.P. 432, L.D. 1280 
applicable federal law and regulations in the testing of reference samples. The increased 
sales of reference samples in this State will generate revenue for the State.' 
SUMMARY 
This amendment requires a drug manufacturer or wholesaler to make a drug available 
for sale at a price no greater than the wholesale acquisition cost rather than at the fair 
market price as provided in Committee Amendment "A" and limits the price charged to 
customers for the drug obtained pursuant to this requirement to no more than the 
wholesale acquisition cost. This amendment also adds an intent section. 
SPONSORED BY: - ~  
~.=-----= 
(Senator JACKSON) 
COUNTY: Aroostook 
FISCAL NOTE REQUIRED 
(See •ttKhed) 
SENA TE AMENDMENT 
Approved: 06/22/17 feac. 
LD 1280 
LR 1232(08) 
An Act Regarding Generic Drug Pricing 
Fiscal Note for Senate Amendment 'N' to Committee Amendment "A" 
Sponsor: Sen. Jacrts'on of Aroostook 
Fiscal Note Required: Yes 
Fiscal Note 
Potential current biennium cost increase - General Fund 
Fiscal Detail and Notes 
This amendment increases the potential risk of constitutionality concerns and may result in increased litigation costs 
to the Department of the Attorney General by an undeterminable amount. 
LR1232(08) - Fiscal Note - Page 1 of 1