LD 1167
pg. 2
Page 1 of 2 An Act to Disclose Prescription Drug Marketing Activities LD 1167 Title Page
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LR 1522
Item 1

 
or services listed under paragraph A or B and those who are
expected to so work during the coming year.__For each person
named, the manufacturer shall also provide information on that
person's compensation, including the cost of benefits and
expense allotments;

 
D.__The cost of all advertising distributed in or originally
distributed from this State regarding prescription drugs
during the past year.__For the purposes of this paragraph,
advertising includes radio, television, Internet, magazines,
newspapers, direct mail, telephone communications and
electronic mail; and

 
E.__For each of the 100 drugs of the manufacturer for which
sales in this State were the highest in the prior year, the
manufacturer's average wholesale price of the drugs, the
lowest price for which the manufacturer sold those drugs in
this State during the previous year and any discounts,
rebates or other adjustments to cost that applied to sales
of those drugs in the previous year.

 
2.__Prescription drug marketing.__The Bureau of Medical
Services shall administer this section in order to assist the
department in its duties as a purchaser of drugs and
administrator of prescription drug programs.

 
A.__The bureau shall collect and manage the information
required to be provided under subsection 1.

 
B.__With the exception of information protected from
disclosure by law, rule or regulation, all information held
by the bureau is a public record within the meaning of Title
1, chapter 13.

 
C.__By February 5th each year, the bureau shall report to
the Legislature on prescription drug marketing practices and
on the cost of prescription drug marketing activities.

 
3.__Required disclosures.__Persons making informational,
educational or sales presentations subject to the requirements of
subsection 1, paragraph A shall disclose in the presentation
information regarding pharmaceutical assistance programs operated
or participated in by the manufacturer and any potential benefit
to the person to whom the presentation is made.

 
4.__Civil violations.__The following provisions apply to
enforcement of this section by the Attorney General.

 
A.__A person who is employed to make informational, educational
or sales presentations within this State on

 
behalf of a manufacturer who is not registered under
subsection 1, paragraph A, or who violates the disclosure
rules adopted pursuant to subsection 3, is subject to a
civil penalty not to exceed $5,000 per violation, plus the
costs of suit, including necessary and reasonable
investigative costs, reasonable expert witness fees and
reasonable attorney's fees, payable to the State.

 
B.__A manufacturer who violates this section or employs or
causes a person to violate this section is subject to a
civil penalty not to exceed $25,000 per violation, plus the
costs of suit, including necessary and reasonable
investigative costs, reasonable expert witness fees and
reasonable attorney's fees, payable to the State.

 
5.__Application.__The requirements of this section apply to
manufacturers, wholesalers and labelers of prescription drugs
subject to the Maine Pharmacy Act.

 
6.__Rules.__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
II-A.

 
SUMMARY

 
This bill requires prescription drug manufacturers,
wholesalers and labelers to register persons employed by them to
make informational, educational and sales presentations in this
State. It requires the reporting of information about those
activities. It requires reports of the average wholesale price
of certain drugs, the lowest prices for which those drugs were
sold and any rebates or discounts applicable to those drugs. It
requires certain disclosures for persons making informational,
educational and sales presentations. The bill charges the
Bureau of Medical Services within the Department of Human
Services with implementing the law and provides for public access
to nonconfidential information and for an annual report. The
bill makes a violation of the registration or the disclosure
requirements a civil violation enforceable by the Attorney
General. The bill authorizes the Department of Human Services to
adopt rules as necessary to implement the law.


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