An Act To Establish a Prescription Drug Academic Detailing Program
Maine Legislature, Session 123, LD 0839
Committee Amendment CA_A_H549 (House)
Amends: 22 MRSA §2700-A

COMMITTEE AMENDMENT ,,11 " to H.P. 638, L.D. 839, Bill, "An Act To 
Establish a Prescription Drug Academic Detailing Program" 
Amend the bill in section I in §2685 by striking out all of subsection 3 (page 2, lines 
to 13 in L.D.) and inserting the fol1owing: 
'3. 
Proeram components. 
Program components must include outreach and 
education regarding the therapeutic and cost-effective use of prescription drugs as issued 
in peer-reviewed scientific. medical and academic research publications and made 
available to prescribers and dispensers of drugs in the State. including through written 
information and through personal visits from program staff. To the extent possible. 
program components must also include information regarding clinical trials, 
pharmaceutical efficacy, adverse effects of drugs, evidence-based treatment options and 
drug marketing approaches that are intended to circumvent competition from generic and 
therapeutical1y equivalent drugs. Academic detailers shall observe standards of conduct 
in their educational materials and written and oral presentations as established by rules 
adopted by the department that are consistent with the following federal regulations 
regarding labeling and false and misleading advertising: the Food and Drug 
Administration labeling requirements of21 Code of Federal Regulations, Part 201 (2007) 
and prescription drug advertising provisions of 21 Code of Federal Regulations. Part 202 
(2007) and the Office of the Inspector General's Compliance Program Guidance for 
Pharmaceutical Manufacturers issued in April 2003, as amended. The rules must require 
academic detailers to disclose evidence-based information about the range and cost of 
appropriate drug treatment options and the health benefits and risks of al1 appropriate 
drugs.' 
Amend the bill by inserting after section 4 the following: 
'Sec. 5. Appropriations and allocations. The following appropriations and 
allocations are made. 
HEALTH AND HUMAN SERVICES, DEPARTMENT OF (FORMERLY DHS) 
COMMITTEE AMENDMENT 
~,. 
~ 
COMMITTEE AMENDMENT" It .. to H.P. 638, L.D. 839 
Prescription Drug Academic Detailing N026 
Initiative: Provides a base allocation for the costs of the prescription drug academic 
detailing program to be funded from a share of the fees collected from prescription drug 
manufacturers under the Maine Revised Statutes, Title 22, section 2700-A, subsection 4. 
OTHER SPECIAL REVENUE FUNDS 
All Other 
OTHER SPECIAL REVENUE FUNDS TOTAL 
SUMMARY 
2007-08 
$500 
$500 
2008-09 
$500 
$500 
This amendment is the majority report of the committee. The amendment clarifies 
that the basis for academic detailing is peer-reviewed scientific, medical and academic 
research publications. The amendment adds the requirement that academic detailers 
observe standards of conduct consistent with certain federal Food and Drug 
Administration and Office of the Inspector General requirements. 
The amendment 
clarifies that the Department of Health and Human Services may adopt routine technical 
rules to implement the prescription drug academic detailing program. The amendment 
also adds an appropriations and allocations section. 
FISCAL NOTE REQUIRED 
(See attacbed) 
COMMITTEE AMENDMENT 
Revised: 06111/07 
.;t!;?aC! 
LD839 
LR 1964(02) 
An Act To Establish a Prescription Drug Academic Detailing Program 
Fiscal Note for Bill as Amended by Committee Amendment" A" 
Committee: Health and Human Services 
Appropriations/Allocations 
Other Special Revenue Funds 
Fiscal Detail and Notes 
Fiscal Note Required: Yes 
Fiscal Note 
2007-08 
$500 
2008-09 
$500 
Projections 
2009-10 
$500 
Projections 
2010-11 
$500 
Provides a base allocation of$500 in fiscal years 2007-08 and 2008-09 for the costs of the prescription drug academic 
detailing program to be funded from a share of the fees collected from prescription drug manufacturers under 22 
MRSA §2700-A, sub-§-4. This base allocation assumes the Department of Health and Human Services will request 
by financial order increases in this allocation as needed and will transfer by journal voucher the revenue needed and 
available to fund the costs of this new program. 
': 
LR1964(02) - Fiscal Note - Page 1 of 1