An Act To Make Certain Prescription Drug Disclosure Laws Consistent with Federal Law
Maine Legislature, Session 125, LD 0719
Committee: Health and Human Services
Sponsors: STRANG BURGESS, McCORMICK, FOSSEL, O'CONNOR, PETERSON, SIROCKI, RECTOR, SNOWE-MELLO, SULLIVAN
Amends: 22 MRSA §1711-E, 22 MRSA §2685, 22 MRSA §2698-A, 22 MRSA §2698-B, 22 MRSA §2700-A

Legislative Document 
No. 719 
H.P. 530 
House of Representatives, February 23, 2011 
An Act To Make Certain Prescription Drug Disclosure Laws 
Consistent with Federal Law 
Received by the Clerk of the House on February 18, 2011.  Referred to the Committee on 
Health and Human Services pursuant to Joint Rule 308.2 and ordered printed pursuant to Joint 
Rule 401. 
HEATHER J.R. PRIEST 
Clerk 
Presented by Representative STRANG BURGESS of Cumberland. 
Cosponsored by Senator McCORMICK of Kennebec and 
Representatives: FOSSEL of Alna, O'CONNOR of Berwick, PETERSON of Rumford, 
SIROCKI of Scarborough, Senators: RECTOR of Knox, SNOWE-MELLO of Androscoggin, 
SULLIVAN of York. 
Be it enacted by the People of the State of Maine as follows: 
Sec. 1.  22 MRSA §1711-E, sub-§1-B, ¶C, as enacted by PL 2007, c. 460, §1, is 
amended to read: 
C.  The provisions of this section are narrowly and carefully tailored to address the 
findings listed in subsection 1-A, to achieve the State's purposes listed in this 
subsection and in conjunction with the following efforts to advance the State's 
compelling interests: 
(1)  Prior authorization and drug utilization review in the MaineCare program 
under section 3174-M; 
(2)  Reporting of a broad array of prescription drug marketing costs under section 
2698-A and subsequent reporting by the department to the Legislature and the 
Attorney General; 
(3)  Prescription drug price disclosure under section 2698-B; 
(4)  Generic and therapeutically equivalent substitution of prescription drugs 
under Title 32, section 13781; and 
(5)  Protection of patient prescription drug information held by health care 
practitioners under section 1711-C. 
Sec. 2.  22 MRSA §2685, sub-§5, as enacted by PL 2007, c. 327, §1, is amended 
to read: 
5.  Funding.  The program may be funded from the General Fund, from federal funds 
and from other special revenue funds.  One half of the funds collected under section 
2700-A, subsection 4 annually must be allocated to the costs of the program.  The 
program may accept funds from nongovernmental health access foundations, the Tobacco 
Manufacturers Act under chapter 263, subchapter 3, undesignated funds associated with 
pharmaceutical marketing and pricing practices acquired through litigation or action of 
the Office of the Attorney General and fees from subscriptions, contracts and agreements 
with private payors as established by rule.  Savings achieved as a result of the program 
may be retained for operation of the program or paid into the General Fund, at the option 
of the department. 
Sec. 3.  22 MRSA §2698-A, as amended by PL 2005, c. 286, §§1 and 2, is 
repealed. 
Sec. 4.  22 MRSA §2698-B, as amended by PL 2005, c. 402, §§1 to 4, is repealed. 
Sec. 5.  22 MRSA §2700-A, as amended by PL 2007, c. 327, §§2 and 3 and c. 362, 
§§1 and 2, is further amended to read: 
§2700-A.  Prohibitions 
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 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). 
B-1.  "Prescriber" means a person who is licensed, registered or otherwise authorized 
in the appropriate jurisdiction to prescribe and administer drugs in the course of 
professional practice. 
C.  "Regulated advertisement" 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: 
(1)  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 
United States Code, Sections 331 and 352(n) and 21 Code of Federal Regulations, Part 
and state rules. 
2-A.  Software prohibition.  Beginning January 1, 2008, a person may not sell or 
distribute in the State computer software that influences or attempts to influence a 
prescribing decision of a prescriber to prescribe a certain drug or that directs a patient to a 
certain pharmacy.  Features of computer software that are prohibited include, but are not 
limited to, pop-up and other advertisements, instant messages and economic incentives 
that are triggered by or in specific response to a selection, act or other input or 
designation of pharmacy by the prescriber or an agent of the prescriber.  This subsection 
does not apply to in-house equipment provided within a hospital for use by prescribers 
and the hospital pharmacy or to information provided to a prescriber about prescription 
drug formulary compliance, patient care management or pharmacy reimbursement. 
3.  Disclosure of clinical trials of prescription drugs.  Beginning October 15, 2005, 
a manufacturer or labeler of prescription drugs that is required to report marketing costs 
for prescription drugs pursuant to section 2698-A shall post, with regard to those 
prescription drugs, 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. 
4.  Fees.   Beginning April 1, 2006, each manufacturer of prescription drugs that are 
provided to Maine residents through the MaineCare program under section 3174-G or the 
elderly low-cost drug program under section 254-D shall pay a fee of $1,000 per calendar 
year to the State.  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 and the prescription drug 
academic detailing program under section 2685.  One half of the annual revenues from 
this subsection must be allocated to and used for the academic detailing program under 
section 2685.  Revenues received under this subsection, with the exception of funding 
designated for the academic detailing program under section 2685, 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 
and shall coordinate the public education program with the prescription drug academic 
detailing program under section 2685. 
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. 
SUMMARY 
This bill strikes the laws related to the reporting of marketing costs, price reporting 
and the disclosure of clinical trials by manufacturers and labelers of prescription drugs.