An Act Requiring Disclosure of Prescription Drug Advertising and Promotional Expenses
Maine Legislature, Session 121, LD 0132
Committee: Health and Human Services
Sponsors: MAYO, FISCHER, RICHARDSON, SAWYER, TREAT, BULL, DUDLEY, LEMOINE, O'NEIL, WOODBURY
Amends: 22 MRSA §2699

12lst MAINE LEGISLATURE 
Legislative Document 
No. 132 
S.P.55 
In Senate, January 21, 2003 
An Act Requiring Disclosure of Prescription Drug Advertising and 
Promotional Expenses 
Reference to the Committee on Health and Human Services suggested and ordered printed. 
Presented by Senator MAYO of Sagadahoc. 
JOY J. O'BRIEN 
Secretary of the Senate 
Cosponsored by Representative FISCHER of Presque Isle, Representative RICHARDSON of 
Brunswick and 
Senators: SAWYER of Penobscot, TREAT of Kennebec, Representatives: BULL of Freeport, 
DUDLEY of Portland, LEMOINE of Old Orchard Beach, O'NEIL of Saco, WOODBURY of 
Yarmouth. 
Printed on recyc led paper 
Be it enacted by the People of the State of Maine as follows: 
Sec. I. 22 MRSA §2699 is enacted to read: 
§2699. 
Advertising and promotional expenses 
A manufacturer or labeler of prescription drugs dispensed in 
this 
State 
that 
employs, 
directs 
or 
utilizes 
marketing 
representatives 
in 
this 
State 
shall 
report 
the 
costs 
of 
advertising and promotional expenses for prescription drugs in 
this State as provided in this section. For the purposes of this 
section, "manufacturer" and "labeler" have the same meanings as 
provided in section 2697, subsection 1. 
1. 
Purposes. 
Advertising 
and 
promotional 
expenses 
for 
prescription drugs in this State must be reported to the Maine 
Health Data Organization, established in chapter 1683, for the 
purposes of assisting this State in its role as a purchaser of 
prescription drugs 
and 
an administrator of prescription drug 
programs, 
enabling 
this 
State 
to 
determine 
the 
scope 
of 
prescription drug advertising and promotional expenses and their 
effect on the cost, utilization and delivery of health care 
services and furthering the role of this State as guardian of the 
public interest. 
2. 
Manner 
of 
reporting. 
By 
July 
1st 
each 
year 
a 
manufacturer or labeler of prescription drugs that directly or 
indirectly distributes prescription drugs 
for dispensation to 
residents of this State shall file an annual report with the 
Maine Health Data Organization in the form and manner provided by 
the organization. 
The report must be accompanied by payment of a 
fee, as set by the organization in rule, to support the work of 
the organization under this section. 
3. 
Content of annual report by manufacturer or labeler. 
The annual report filed under 
subsection 2 must include the 
following 
information 
as 
it 
pertains 
to 
advertising 
and 
promotional activities conducted within this State: 
A. 
All expenses associated with advertising, marketing and 
direct 
promotion 
of 
prescription 
drugs 
through 
radio, 
television, magazines, newspapers, direct mail and telephone 
communications as they pertain to residents of this State; 
B. 
With regard to all persons and entities licensed to 
provide health care in this State, including health care 
professionals and persons employed by them in this State, 
carriers licensed under Title 24 or Title 24-A, health plans 
and 
benefits 
managers, 
pharmacies I 
hospitals I 
nursing 
facilities, clinics and other entities licensed to provide 
Page l-LR0038(1) 
.. 
health care 
under this Title, 
the 
following 
information 
provided in a form that provides the value, nature, purpose 
and recipient of the expense: 
(1) 
All 
expenses 
associated 
with 
educational 
or 
informational 
programs, 
materials 
and 
seminars 
and 
remuneration 
for 
promoting 
or 
participating 
in 
educational or informational sessions, 
regardless of 
whether 
the 
manufacturer 
or 
labeler 
provides 
the 
educational or informational sessions or materials: 
(2) All expenses associated with food, entertainment. 
gifts valued at more than $25 and anything provided to 
a health care professional for less than market value; 
(3) All expenses associated with trips and travel; and 
(4) 
All 
expenses 
associated 
with 
product 
samples , 
except for samples that will be distributed free of 
charge to patients; and 
C. 
The aggregate cost of all employees or contractors of 
the 
manufacturer 
or 
labeler 
who 
directly or 
indirectly 
engage in the advertising or promotional activities listed 
in paragraphs A and Bf including all forms of payment to 
those employees. 
The cost reported under this paragraph 
must reflect only that portion of payment to employees or 
contractors that pertains to activities within this State or 
to recipients of the advertising or promotional activities 
who are residents of or are employed in this State. 
4. 
Exceptions. 
The following advertising and promotional 
expenses are not subject to the requirements of this section: 
A. 
Expenses of $25 or less; 
B. 
Reasonable compensation and reimbursement for expenses 
in connection with a 
bona fide clinical trial of a 
new 
vaccine, therapy or treatment; and 
C. 
Scholarships and reimbursement of expenses for attending 
a 
significant 
educational, 
scientific 
or 
policy-making 
conference or seminar of a national, regional or specialty 
medical or other professional association if the recipient 
of the scholarship is chosen by the association sponsoring 
the conference or seminar. 
5. 
Maine Health Data Organization reports. 
By November 
30th each year the Maine Health Data Organization shall provide 
an annual report. providing information in aggregate form, 
on 
prescription drug advertising and promotional expenses to the 
Legislature. 
By January 1. 2005 and every 2 years after that 
date, the Maine Health Data Organization shall provide a report, 
providing information in aggregate form, containing an analysis 
of the data submitted to the organization, including the scope of 
prescription drug 
advertising 
and 
promotional 
activities 
and 
expenses and their effect on the cost, utilization and delivery 
of health care services and any recommendations with regard to 
advertising 
and 
promotional 
activities 
of 
prescription 
drug 
manufacturers and labelers. 
6. 
Confidentiality: 
public 
infonnation. 
Information 
submitted to the Maine Health Data Organization pursuant to this 
section is confidential and is not a public record as defined in 
Title L 
section 402, subsection 3. 
Data compiled in aggregate 
form by the organization for the purposes of reporting required 
by this section is a public record as defined in Title 1, section 
402, 
subsection 
3, 
as 
long 
as 
it does 
not 
reveal 
trade 
information that is protected by state or federal law. 
7. 
Penalty. 
A manufacturer 
or 
labeler 
that fails 
to 
provide a report as required by this section commits a civil 
violation for which a fine of $1000 may be adjudged, plus costs 
and attorney's fees. 
8. 
Rulema1dng. 
The Maine Health Data Organization shall 
adopt rules to implement this section. 
Rules adopted pursuant to 
this section are routine technical rules as defined in Title 5, 
chapter 375, subchapter 2-A. 
Sec. 2. Effective date. 
This Act takes effect January 1, 2004. 
SUMMARY 
This 
bill 
requires 
prescription 
drug 
manufacturers 
and 
labelers whose drugs are dispensed to Maine residents to file 
annual reports with the Maine Health Data Organization regarding 
their expenses for advertising and promoting their drugs. 
The 
bill requires the Maine Health Data Organization to 
file an 
annual report regarding the information filed and 
a biennial 
report 
that 
contains 
analysis 
of 
information 
and 
recommendations. 
The bill continues the confidentiality of trade 
information that is protected under state and federal law. 
The 
bill provides for a fine of $1,000 for failure to report as 
required. 
The bill provides for rulemaking by the Maine Health 
Data Organization and contains an effective date of January 1, 
2004. 
..