An Act Regarding Generic Drng Pricing
Maine Legislature, Session 128, LD 1280
Committee Amendment CA_A_S153 (Senate)
Amends: 32 MRSA §13800

COMMITTEE AMENDMENT "A" to S.P. 432, L.D. 1280, Bill, "An Act 
Regarding Generic Drng Pricing" 
Amend the bill by striking out the title and substituting the following: 
'An Act To Require Drug Manufacturers To Comply with Federal Law' 
Amend the bill in section 4 in subsection 4 in the last line (page l, line 18 in L.D.) by 
inserting after the following: "E." the following: 'If the Attorney General prevails in an 
action under this subsection, the court must order the person to reimburse the State for the 
Attorney General's costs of prosecuting the action, including reasonable attorney's fees.' 
Amend the bill by striking out all of section 5 and insetting the following: 
'Sec. 5. 32 MRSA §13800 is enacted to read: 
§13800. Access to distributed drugs 
A manufacturer or wholesaler licensed under section 13758 shall make a drng 
distributed in this State available for sale in this State to an eligible product developer for 
purposes of conducting testing required to supp01t an application for approval of a drug 
under the Federal Food, Drug, and Cosmetic Act, Section 505(b) or 505(j) or the 
licensing of a biological product under the federal Public Health Service Act, Section 
351. 
The manufacturer or wholesaler licensed under section 13758 shall make the drug 
available for sale at fair market price and without any restriction that would block or 
delay the eligible product developer's application in a manner inconsistent with Section 
505-1(£)(8) of the Federal Food, Drug, and Cosmetic Act, 21 United States Code, Section 
355-1(£)(8) (2016).' 
SUMMARY 
This amendment, which is the majority report of the committee, clarifies that the bill's 
requirement that a drug distributed in this State be made available for sale to an eligible 
COMMITTEE AMENDMENT 
COMMITIEE AMENDMENT" Dr." to S.P. 432, L.D. 1280 
product developer applies only to manufacturers and wholesalers of drugs licensed in this 
State under the Maine Pharmacy Act. The amendment further requires sale of a drug 
distributed in this State to eligible product developers at a fair market price for purposes 
of supporting the eligible product developer's application for approval of a drug under the 
Federal Food, Drug, and Cosmetic Act, Section 505(b) or 505(j) or the licensing of a 
biological product under the federal Public Health Service Act, Section 351. 
The 
licensed manufacturer or wholesaler may not impose any restriction on the sale that 
would block or delay the eligible product developer's application in a manner inconsistent 
with Section 505-1(£)(8) of the Federal Food, Drug, and Cosmetic Act, 21 United States 
Code, Section 355-1(£)(8) (2016). 
The amendment ensures increased competition in the market for drugs and biological 
products, which will lower the cost of prescription drugs for Maine residents and for the 
State. Developers oflow-cost generic drugs and biosimilar biological products must have 
access to approved drugs distributed in this State by licensed wholesalers and 
manufacturers to engage in bioequivalence and biosimilarity testing prior to receiving 
approval from the Food and Drug Administration, or FDA, for sale of their generic drugs 
and biosimilar biological products. 
Federal laws and regulations governing 
bioequivalence and biosimilarity testing are designed to ensure availability of generic 
drugs and biosimilar biological products in a timely manner without risking patient 
safety, even in cases where an FDA-approved drug is subject to iisk evaluation and 
mitigation strategies and elements to assure safe use, or REMS with ETASU, under 
Section 505-1 of the Federal Food, Drug, and Cosmetic Act, 21 United States Code, 
Section 355-1 (2016). Wholesalers and manufacturers of FDA-approved drugs have used 
REMS with ET ASU programs imposed by the FDA as excuses for refusing to sell their 
drugs and biological products to eligible product developers, despite the prohibition in 
Section 505-1(£)(8) of the Federal Food, Drug, and Cosmetic Act, 21 United States Code, 
Section 355-1(£)(8) against such use of REMS with ETASU requirements "to block or 
delay approval" of a new generic drug or biosimilar biological product. 
lflt:il.'AL NOTE REQUIRED 
(See attached) 
COMMITTEE AMENDMENT 
Approved: 05/21/17 .wac 
LD 1280 
LR 1232(02) 
An Act Regarding Generic Drug Pricing 
Fiscal Note for Bill as Amended by Committee Amendment "d/ (S-/53) 
Committee: Labor, Commerce, Research and Economic Development 
Fiscal Note Required: Yes 
Fiscal Note 
Minor cost increase - General Fund 
Fiscal Detail and Notes 
Any additional costs can be absorbed by the Department of the Attorney General utilizing existing budgeted 
resources. 
LR1232(02) - Fiscal Note - Page 1 of 1