An Act Regarding Advertising by Drug Manufacturers
Maine Legislature, Session 122, LD 1618
Committee: Health and Human Services
Sponsors: LERMAN, CAMPBELL, BRAUTIGAM, BURNS, GROSE, MILLER, PINGREE, BRENNAN, MAYO

Legislative Document 
No. 1618 
H.P. 1141 
House of Representatives, May 3, 2005 
An Act Regarding Advertising by Drug Manufacturers 
Reference to the Committee on Health and Human Services suggested and ordered printed. 
!r/~ 
/h·11Id£~ 
MILLICENT M. MacFARLAND 
Clerk 
Presented by Representative LERMAN of Augusta. 
Cosponsored by Representative CAMPBELL of Newfield and 
Representatives: BRAUTIGAM of Falmouth, BURNS of Berwick, GROSE of Woolwich, 
MILLER of Somerville, PINGREE of North Haven, Senators: BRENNAN of Cumberland, 
MAYO of Sagadahoc. 
Printed on recycled paper 
Be it enacted by the People of the State of Maine as follows: 
Sec. 1. 22 MRSA c. 605 is enacted to read: 
CHAPTER 605 
PRESCRIPTION DRUG ADVERTISING 
§2700-A. 
Prohibitions and required disclosures 
1. 
Definitions. 
As 
used 
in this 
chapter, 
unless 
the 
.cQntext otherwise 
indi_~es, "tlinical trial" means a clinicil 
investigation 
as 
defined 
by 
the 
federal 
Food 
and 
Drug 
Administration that involves any experiment to test the safety or 
efficacy of a drug or biological product with one or more human 
subjects 
and is 
i~ed to 
be 
sUQmitted to, 
or 
held 
for 
inspection by, the federal Food and Dryg Administration as part 
of an application for a research or marketing permit. 
2. AdQption of federal law and regulations by reference. 
The department shall adopt rules to incorporate by reference 
federal 
statutes 
and 
regulations 
in 
United States 
Code, 
~ctions 331 and 352(n) and 21 Code of Federal Regulations, Part 
and may adopt amendments to those statutes and regulations 
that are not inconsistent with those statutes and regulations. 
Rules adopted pursuant to this subsection are routine technical 
rules as defined in Title 5, chapter 375, subchapter 2-A. 
3. 
Misbranding 
and 
certain 
advertising 
prohibited. 
A 
manufacturer 
may 
not 
present 
or 
cause 
to 
be 
presented 
an 
advertisement for a prescription drug in a television broadcast, 
radio broadcast or printed material that originates in this 
State, 
unless 
that 
advertisement 
meets 
the 
requirements 
of 
federal 
laws 
and regulations 
con~rning misbranded drugs 
and 
devices and prescription drug advertising as adopted by reference 
by rule of the department pursuant to subsection 2. 
4. 
Disclosure of clinical trials. 
A manufacturer may not 
present 
or 
cause 
to 
be 
presented 
an 
advertisement 
for 
a 
prescription drug in a television broadcast, radio broadcast or 
printed material 
that originates 
in this State, 
unless 
the 
manufacturer has disclosed to the department, on a form provided 
~he department, 
the 
following 
information 
concerning 
any 
clinical trial of the prescription drug that the manufacturer has 
conducted or sponsored or is in the process of conducting or 
sponsoring: 
A. 
The name of the entity that conducted or is conducting 
the clinical trial; 
Page l-LR0487(1) 
B. A summary of the purpose of the clinical trial; 
C. The dates during which the trial has taken place; 
D. Information concerning the results of the clinical trial, 
including potential or actual adverse effects of the drug; 
and 
E. Any other information determined by the commissioner to 
be relevant. 
This subsection applies to clinical trials commenced on or after 
October 15. 2005. 
S. Immunity. 
Notwithstanding any other provision of law to 
the contrary, 
a 
person who is required or authorized by the 
commissioner to report. receive or disclose information pursuant 
to this chapter is immune from liability for reporting. receiving 
or disclosing that information in accordance with the provisions 
of this chapter or any rule adopted pursuant to this chapter. 
6. Penalties. 
A violation of this chapter is a violation of 
the Maine Unfair Trade Practices Act. for which a fine of not 
more than $10.000 may be adjudged. 
Each day a manufacturer is in 
violation of this chapter is considered a separate violation. 
1. 
Fee. 
For 
each 
prescription 
drug 
advertised 
in 
a 
television broadcast. radio broadcast or printed material that 
originates in this State. the drug's manufacturer shall pay a fee 
to the department. determined by the department by rule and not 
to 
exceed 
$500, 
to 
of~t the 
cost 
of 
implementing 
and 
maintaining a clinical trial database. 
Rules adopted pursuant to 
this subsection are routine technical rules as defined in Title 
5, chapter 375. subchapter 2-A. 
Sec. 2. Commissioner of Health and Human Services to provide 
access to clinical trial information. 
The Commissioner of Health and 
Human 
Services 
shall maintain 
a 
database 
of 
clinical trial 
information provided pursuant to the 
Maine 
Revised Statutes, 
Ti tle 22, 
section 2700-A and to the extent permissible under 
federal 
law 
shall 
provide 
access 
to 
the 
public 
to 
that 
information through an Internet website. 
The commissioner may 
adopt rules to implement the purposes of this section. 
Any rules 
adopted pursuant to this section are routine technical rules as 
defined in Title 5, chapter 375, subchapter 2-A. 
SUMMARY 
This bill 
requires 
the 
Department 
of 
Health 
and 
Human 
Services to adopt rules incorporating by reference federal laws 
and 
regulations 
concerning misbranded 
drugs 
and 
devices 
and 
prescription drug advertising. 
The bill also 
requires 
drug 
manufacturers to provide information concerning clinical trials 
of prescription drugs advertised in the State, provides immunity 
for disclosure of that information, directs the department to 
maintain this information on an Internet website and enables the 
department to collect a 
fee 
from manufacturers to support 
a 
clinical trial database. 
The bill makes violations of these 
requirements violations of the Maine Unfair Trade Practices Act, 
which are subject to a fine of not more than $10,000.