An Act To Require Full Disclosure of Prescription Drug Marketing Costs
Maine Legislature, Session 121, LD 0254
Committee: Health and Human Services
Sponsors: KANE, TREAT, CUMMINGS, FISCHER, LEMOINE, NORBERT, O'NEIL, SIMPSON, TWOMEY, MAYO
Amends: 22 MRSA §2699

Legislative Document 
No. 254 
H.P.209 
House of Representatives, January 23, 2003 
An Act To Require Full Disclosure of Prescription Drug Marketing 
Costs 
Reference to the Committee on Health and Human Services suggested and ordered printed. 
Presented by Representative KANE of Saco. 
Cosponsored by Senator TREAT of Kennebec and 
77/~ 
/J7.7l/dc~ 
MILLICENT M. MacFARLAND 
Clerk 
Representatives: CUMMINGS of Portland, FISCHER of Presque Isle, LEMOINE of Old 
Orchard Beach, NORBERT of Portland, O'NEIL of Saco, SIMPSON of Auburn, TWOMEY of 
Biddeford, Senator: MAYO of Sagadahoc. 
Printed on recycled paper 
Be it enacted by the People of the State of Maine as follows: 
Sec. I. 22 MRSA §2699 is enacted to read: 
§2699. 
Marketing costs 
A manufacturer or labeler of prescription drugs dispensed in 
this 
State 
that 
employs, 
directs 
or 
utilizes 
marketing 
representatives in this State shall report marketing costs for 
prescription drugs in this State as provided in this section. 
1. 
Pu~ses. 
Marketing costs for prescription drugs in 
this State must be reported to the department 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 
marketing costs 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. 
Definitions. 
As 
used 
in this 
section, 
unless 
the 
context 
otherwise 
indicates , 
the 
following 
terms 
have 
the 
following meanings. 
A. 
"Labeler" has the same meaning as provided in section 
2697, subsection 1. 
B. 
"Manufacturer" 
has 
the 
same 
meaning 
as 
provided in 
section 2697, subsection 1. 
C. 
"Marketing" 
means 
advertising 
and 
promotional 
activities, including, but not limited to, the activities 
described in subsection 4. 
3. 
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 a report with the department 
in the form and manner provided by the department. 
The report 
must be accompanied by payment of a fee, as set by the department 
in rule, to support the work of the department under this section. 
4. 
Content of annual report by manufacturer or labeler. 
The 
annual report filed under subsection 3 must 
include the 
following information as it pertains to marketing activities 
conducted within this State in a form that provides the value, 
nature, purpose and recipient of the expense: 
A. 
All expenses associated with advertising, marketing and 
direct 
promotion 
of 
prescription 
drugs 
through 
radio, 
Page l-LR0072(1) 
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, 
hospitals, 
nursing 
facili ties, clinics and other entities licensed to provide 
health care under this Title, the following information: 
( 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 B, 
including all forms of payment 
tc' 
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. 
5. 
Exc~tiQns. 
The following marketing 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. 
6. 
Department reports. 
By November 30th each year, 
the 
department shall provide an annual report, providing information 
in aggregate form, on prescription drug marketing expenses to the 
Legislature and the Attorney General. 
By January 1, 
2005 and 
every 2 years after that date, the department shall provide a 
report to the Legislature and the Attorney General, providing 
information in aggregate form, containing an analysis of the data 
submitted to the department, including the scope of prescription 
drug marketing activities and expenses and their effect on the 
cost. utilization and delivery of health care services and any 
recommendations 
with 
regard 
to 
marketing 
activities 
o( 
prescription drug manufacturers and labelers. 
1. 
Confidentiality; 
public 
information. 
Notwithstanding 
any provision of law to the contrary, information submitted to 
the department pursuant to this section is confidential and is 
not 
a 
public 
record 
as 
defined 
in Title 
1, 
section 
402, 
subsection 3. 
Data compiled in aggregate form by the department 
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. 
8. 
Penalty. 
This section may be enforced in a civil action 
brought by the Attorney General. 
A manufacturer or labeler that 
fails to provide a report as required by this section commits a 
civil violation for which 
a 
fine of $10,000 plus costs 
and 
attorney's fees may be adjudged. 
9. 
Ru!emaking. 
The 
department 
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 state residents to file 
annual reports with the Department of Human Services regarding 
their expenses for marketing their drugs. 
The bill requires the 
department to file an annual report with the Legislature and the 
Attorney General 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 $10,000 for failure to report as 
required. 
The bill provides for rulemaking by the department and 
contains an effective date of January 1, 2004.