An Act To Make Certain Prescription Drug Disclosure Laws Consistent with Federal Law
Maine Legislature, Session 125, LD 0719
Committee Amendment CA_B_H648 (House)

COMMITTEE AMENDMENT ,B "to H.P. 530, L.D. 719, Bill, "An Act To Make 
Certain Prescription Drug Disclosure Laws Consistent with Federal Law" 
Amend the bill in section 1 in paragraph C by striking out all of subparagraph (3) 
(page 1, line 13 in L.D.) and inserting the following: 
'(3) Prescription drug price disclosure under section 2698-B;' 
Amend the bill by striking out all of section 4. 
Amend the bill in section 5 in §2700-A in subsection 1 by striking out all of 
paragraph A and inserting the following: 
'A. "Clinical trial" means a clinical investigation as defined by the federal Food and 
Drug Administration that involves any trial to test the safety or efficacy of a drug or 
biological product with one or more human subjects and that is intended to be 
submitted to, or held for inspection by, the federal Food and Drug Administration as 
part of an application for a research or marketing permit.' 
Amend the bill in section 5 in §2700-A by inserting after subsection 3 the following: 
'3-A. 
Clinical trial information. 
The department shall post on its publicly 
accessible website links to clinical trial information available to the public through the 
United States Department of Health and Human Services and other sources.' 
Amend the bill in section 5 in §2700-A by striking out all of subsection 4 and 
inserting the following: 
'4. Fees. Beginning April 1, 2006, each manufacturer of prescription drugs that are 
provided to Maine residents through the MaineCare program under section 3174-G or the 
elderly low-cost drug program under section 254-D shall pay a fee of $1 ,000 per calendar 
year to the State. Fees collected under this subsection must be used to cover the cost of 
overseeing implementation of this section, including but not limited to maintaining links 
to publicly accessible websites to which manufacturers are posting clinical trial 
information under subsection ~ 3-A and other relevant sites, assessing ,>"hether and the 
extent to which Maine residents have been harmed by the use of a particular drug and 
COMMITTEE AMENDMENT 
~. ;. ft· 
COMMITTEE AMENDMENT j" 
to RP. 530, L.D. 719 
uHdertakiHg the public educatioH iHitiative uHder subsectioH 5 and the prescription drug 
academic detailing program under section 2685. One half of the annual revenues from 
this subsection must be allocated to and used for the academic detailing program under 
section 2685. Revenues received under this subsection, with the exception of funding 
designated for the academic detailing program under section 2685, must be deposited into 
an Other Special Revenue Funds account to be used for the purposes of this subsection.' 
Amend the bill in section 5 in §2700-A by striking out all of subsections 6 and 7 and 
inserting the following: 
'6. Penalties. A violation of this section is a violation of the Maine Unfair Trade 
Practices Act. Each day a manufacturer is in violation of this chapter is considered a 
separate violation. -
7. Rulemaking. The department may adopt rules to implement this section. Rules 
adopted pursuant to this subsection are routine technical rules as defined in Title 5, 
chapter 375, subchapter 2-A.' 
Amend the bill by adding after section 5 the following: 
'Sec. 6. Report. By January 15, 2012 the Department of Health and Human 
Services shall report to the Joint Standing Committee on Health and Human Services 
regarding: 
1. The mechanism that is being used to reimburse pharmacies for prescription drugs 
reimbursed under the MaineCare program; 
2. 
The mechanism for reimbursement being considered by the United States 
Department of Health and Human Services, Centers for Medicare and Medicaid Services 
for use in the future; 
3. Options for ensuring transparency and accurate reporting in reimbursement for 
prescription drugs under the MaineCare program and for ensuring that Maine receives the 
maximum rebates allowed by federal law. 
Sec. 7. Appropriations and allocations. The following appropriations and 
allocations are made. 
HEALTH AND HUMAN SERVICES, DEPARTMENT OF (FORMERLY DHS) 
Bureau of Medical Services 0129 
Initiative: Reduces funding as a result of reductions in the drug marketing program and 
fees, partially offset by the restoration of the fee for the drug academic detailing program. 
OTHER SPECIAL REVENUE FUNDS 
All Other 
OTHER SPECIAL REVENUE FUNDS TOTAL 
2011-12 
($96,000) 
($96,000) 
2012-13 
($96,000) 
($96,000) 
Amend the bill by relettering or renumbering any nonconsecutive Part letter or 
section number to read consecutively. 
COMMITTEE AMENDMENT 
COMMITTEE AMENDMENTj" to H.P. 530, L.D. 719 
SUMMARY 
This amendment is the minority report of the committee. It does not repeal a section 
of current law on prescription drug pricing, restores the $500 fee per manufacturer that 
supports the academic detailing program, requires the Department of Health and Human 
Services to post website links to clinical trial information and retains provisions regarding 
penalties and rulemaking. The amendment also adds an appropriations and allocations 
section. 
FISCAL NOTE REQUIRED 
(See attached) 
COMMITTEE AMENDMENT 
Approved: 06/13/11 
;1Qac. 
LD 719 
LR 1590(03) 
An Act To Make Certain Prescription Drug Disclosure Laws Consistent with Federal Law 
Fiscal Note for Bill as Amended by Committee Amendment~" 
Appropriations/Allocations 
Other Special Revenue Funds 
Revenue 
Other Special Revenue Funds 
Fiscal Detail and Notes 
Committee: Health and Human Services 
Fiscal Note Required: Yes 
Fiscal Note 
FY 2011-12 
FY 2012-13 
($96,000) 
($96,000) 
($96,000) 
($96,000) 
Projections 
FY 2013-14 
($96,000) 
($96,000) 
Projections 
FY 2014-15 
($96,000) 
($96,000) 
Assumes a reduction in funding as a result of a reduction in the drug marketing program and fees that are partially 
offset by the restoration of the fee for the drug academic detailing program. 
LR1590(03) - Fiscal Note - Page 1 of 1