An Act Regarding Advertising by Drug Manufacturers
Maine Legislature, Session 122, LD 1618
Committee Amendment CA_A_H661 (House)

COMMITTEE AMENDMENT "A" to 
Regarding Advertising by Drug 
H.P. 1141, L.D. 
Manufacturers" 
1618, Bill, "An 
Amend the bill by striking out everything after the enacting 
clause and before the summary and inserting in its place the 
following: 
I Sec. 1. 22 MRS A c. 605 is enacted to read: 
CHAPTER 605 
PRESCRIPTIOB DRUG ADVERTISIHG 
§2700-A. 
Prohibitions and regyired disclosures 
1. 
Definitions. 
As 
used in this 
chapter, 
unless 
the 
context 
otherwise 
indicates, 
the 
following 
terms 
have 
the 
following meanings. 
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. 
B. 
"Manufacturer of prescription drugs" or "manufacturer" 
means 
a manufacturer of prescription drugs or biological 
products or an affiliate of the manufacturer or a labeler 
that receives prescription drugs or biological products from 
a manufacturer or wholesaler and repackages those drugs or 
Page l-LR0487(2) 
COMMITTEE AMENDMENT 
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COMMITTEE AMENDMENT "A" to H.P. 1141, L.D. 1618 
biological products for later retail sale and that has a 
labeler code from the federal Food and Drug Administration 
under 21 Code of Federal Regulations, 2027.20 (1999). 
C. 
"Regulated adverti sement" means the presentation to the 
general 
public 
of 
a 
commercial 
message 
regarding 
a 
prescription drug or biological product by a manufacturer of 
prescription drugs that is: 
(l) 
Broadcast on television or radio from a station 
that is physically located in the State; 
(2) 
Broadcast over the Internet from a location in the 
State; 
or 
(3) 
Printed 
in 
magazines 
or 
newspapers 
that 
are 
printed, distributed or sold in the State. 
2. Regulated advertisement requirement. 
Beginning October 
15, 2005, a manufacturer may not present or cause to be presented 
in the State a regulated advertisement, unless that advertisement 
meets the requirements concerning misbranded drugs and devices 
and prescription drug advertising of federal law and regulations 
under 21 United States Code, Sections 331 and 352(n) and 21 Code 
of Federal Regulations, Part 202 and state rules. 
3. 
Prior disclosure of clinical trials of prescription 
drugs. 
Beginning October 
IS. 
2005, 
a 
manufacturer 
may 
not 
present or cause to be presented a regulated advertisement in 
this State, unless, with regard to the prescription drug that is 
the subject of the regulated advertisement, the manufacturer has 
posted 
on 
the 
publicly 
accessible 
Internet 
website 
of 
the 
federal 
National Institutes of Health or its successor agency or 
another publicly accessible website the following information 
concerning any clinical trial that the manufacturer conducted or 
sponsored on or after October 15, 2002: 
A. The name of the entity that conducted or is conducting 
the clinical trial; 
B. A summary of the purpose of the clinical trial; 
C. The dates during which the trial has taken place: and 
D. Information concerning the results of the clinical trial. 
including potential or actual adverse effects of the drug. 
In order to satisfy the requirements of this subsection, 
the 
publicly accessible 
website 
and 
manner 
of 
posting 
must 
be 
acceptable to the department. 
COMMITTEE AMENDMENT 
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COMMITTEE AMENDMENT ,A" to H.P. 1141, L.D. 1618 
4. 
Fees. 
Beginning April L 
2006, each manufacturer of 
prescription drugs that are provided to Maine residents through 
the 
MaineCare 
program 
under 
section 
3l74-G 
or 
the 
elderly 
low-cost drug program under section 254 shall pay a fee of $1,000 
per calendar year to the department. 
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 and other relevant sites, assessing whether and the 
extent to which Maine residents have been harmed by the use of a 
particular drug and undertaking the public education initiative 
under subsection 5. 
Revenues received under this subsection must 
be deposited into an Other Special Revenue Funds account to be 
used for the purposes of this subsection. 
5. 
Public education initiative. 
The 
department 
shall 
undertake a public education initiative to inform residents of 
the State about clinical trials and drug safety information. 
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. 
Sec. 2. Report. 
By January 15, 2007, the Department of Health 
and Human Services shall report to the joint standing committee 
of the Legislature having jurisdiction over health and human 
services matters regarding compliance with the Maine 
Revised 
Statutes, Title 22, section 2700-A, the completeness and ease of 
public access to information provided by the drug manufacturers 
and the need for further action or legislation.' 
SUMMARY 
This amendment is the majority report of the committee. 
The 
amendment replaces the bill. 
It: 
1. Defines "clinical trial," "manufacturer of prescription 
drugs" and "regulated advertisement"; 
2. 
Requires drug manufacturers to disclose clinical trial 
information regarding drugs that are advertised in the State; 
COMMITTEE AMENDMENT 
COMMITTEE AMENDMENT ·A .. to H.P. 1141, L.D. 1618 
3. 
Requires manufacturers to pay fees that will be used to 
support overseeing the implementation of the new prescription 
drug advertising laws, including maintaining links to publicly 
accessible websites to which manufacturers are posting clinical 
trial information, assessing harm from drugs to Maine residents 
and undertaking a public education initiative; 
4. 
Provides 
penal ties 
under 
the 
Maine 
Unfair 
Trade 
Practices Act for failure to comply; 
5. Directs the Department of Health and Human Services to 
adopt rules to implement the provisions; and 
6. 
Directs the Department of Health and Human Services to 
report by January 15, 2007 on compliance with the provisions, the 
completeness of and ease of public access to information provided 
by 
drug 
manufacturers 
and 
the 
need 
for 
further 
action or 
legislation to the joint standing committee of the Legislature 
having jurisdiction over health and human services matters. 
FISCAL NOTE REQUIRED 
(See attached) 
COMMITTEE AMENDMENT 
Approved: 06/03/05 ~ae 
LD 1618 
LR0487(02) 
An Act Regarding Advertising by Drug Manufacturers 
Fiscal Note for Bill as Amended by Committee Amendment ~" 
Committee: Health and Human Services 
Fiscal Note Required: Yes 
Majority Report 
Fiscal Note 
Undetermined current biennium revenue increase - Other Special Revenue Funds 
Undetermined current biennium cost increase - Other Special Revenue Funds 
Minor cost increase - General Fund 
Minor revenue increase - General Fund 
-:orrectional and Judicial Impact Statements 
Establishes new violations of the Maine Unfair Trade Practices Act. 
The collection of additional fines may increase General Fund revenue by minor amounts. 
Fiscal Detail and Notes 
Assumes additional costs to the Department of Human Services to implement the provisions of the bill would be 
funded with fees on certain manufacturers of prescription drugs. The amount of fees that will be generated cannot be 
determined at this time. 
Any additional costs to the Department of the Attorney General can be absorbed utilizing existing budgeted resources. 
LR0487(2) - Fiscal Note - Page 1 of 1