96TH GENERAL ASSEMBLY
State of Illinois
2009 and 2010
HB0332

 

Introduced 1/27/2009, by Rep. Jack D. Franks

 

SYNOPSIS AS INTRODUCED:
 
New Act
30 ILCS 105/5.719 new

    Creates the Prescription Drug Ethical Marketing Act. Requires every manufacturer and labeler that sells prescription drugs in the State to disclose to the Director of Public Health the value, nature, and purpose of any gift, fee, payment, subsidy, or other economic benefit provided in connection with detailing or promotional or other marketing activities by the company, directly or through its pharmaceutical marketers, to any physician, hospital, nursing home, pharmacist, health benefit plan administrator, or any other person in the State authorized to prescribe or dispense prescription drugs. Requires the Director to report to the Governor and the General Assembly on the disclosures. Provides exceptions to the disclosures. Provides for injunctive relief and civil penalties for failure to disclose. Amends the State Finance Act to create the Prescription Drug Ethical Marketing Fund.


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FISCAL NOTE ACT MAY APPLY

 

 

A BILL FOR

 

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1     AN ACT concerning public health.
 
2     Be it enacted by the People of the State of Illinois,
3 represented in the General Assembly:
 
4     Section 1. Short title. This Act may be cited as the
5 Prescription Drug Ethical Marketing Act.
 
6     Section 5. Findings and purpose.
7     (a) The General Assembly finds that:
8         (1) Prescription drug spending is the fastest growing
9     component of health care spending in the United States.
10         (2) Drug manufacturers' marketing to doctors, called
11     "detailing", is affecting the way that doctors prescribe
12     medications so that they too often prescribe the most
13     expensive medicines when less expensive drugs are as
14     effective or safer.
15         (3) Gifts from prescription drug detailers can
16     influence the decisions of doctors in terms of the
17     medicines that they prescribe.
18     (b) The purpose of this Act is to lower prescription drug
19 costs for individuals, businesses, and the State and to protect
20 the health of residents by deterring the practice of unethical
21 gift-giving by drug manufacturers.
 
22     Section 10. Definitions. As used in this Act:

 

 

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1     "Director" means the Director of Public Health.
2     "Labeler" means an entity or person that receives
3 prescription drugs from a manufacturer or wholesaler and
4 repackages those drugs for later retail sale and that has a
5 labeler code from the Food and Drug Administration under 21
6 C.F.R. 207.20. "Labeler" does not include a retail pharmacy or
7 pharmacist that labels a prescription vial.
8     "Manufacturer" means a manufacturer of prescription drugs
9 as defined in 42 U.S.C. 1396r-8 (k)(5), including a subsidiary
10 or affiliate of a manufacturer.
11     "Pharmaceutical marketer" means a person who, while
12 employed by or under contract to represent a manufacturer or
13 labeler, engages in pharmaceutical detailing, promotional
14 activities, or other marketing of prescription drugs in this
15 State to any physician, hospital, nursing home, pharmacist,
16 health benefit plan administrator, or any other person
17 authorized to prescribe or dispense prescription drugs.
 
18     Section 15. Disclosure of marketing practices.
19     (a) On or before January 1 of each year, every manufacturer
20 and labeler that sells prescription drugs in the State shall
21 disclose to the Director the name and address of the individual
22 responsible for the company's compliance with the provisions of
23 this Section.
24     (b) On or before February 1 of each year, every
25 manufacturer and labeler that sells prescription drugs in the

 

 

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1 State shall disclose to the Director the value, nature, and
2 purpose of any gift, fee, payment, subsidy, or other economic
3 benefit provided in connection with detailing or promotional or
4 other marketing activities by the company, directly or through
5 its pharmaceutical marketers, to any physician, hospital,
6 nursing home, health benefit plan administrator, or any other
7 person in Illinois authorized to prescribe prescription drugs.
8 Disclosure shall cover the prior year and it shall be made on a
9 form and in a manner prescribed by the Director.
10     (c) On or before March 1 of each year, the Director shall
11 report to the Governor and the General Assembly on the
12 disclosures made under this Section.
13     (d) The following shall be exempt from disclosure:
14         (1) Any gift, fee, payment, subsidy or other economic
15     benefit, the value of which is less than $25.
16         (2) Free samples of prescription drugs to be
17     distributed to patients.
18         (3) The payment of reasonable compensation and
19     reimbursement of expenses in connection with a bona fide
20     clinical trial conducted in connection with a research
21     study designed to answer specific questions about
22     vaccines, new therapies, or new ways of using known
23     treatments.
24         (4) Scholarship or other support for medical students,
25     residents, and fellows to attend a bona fide educational,
26     scientific, or policy-making conference of an established

 

 

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1     professional association if the recipient of the
2     scholarship or other support is selected by the
3     association.
 
4     Section 20. Administration; enforcement; Prescription Drug
5 Ethical Marketing Fund.
6     (a) This Act shall be enforced by the Director, who shall
7 adopt any rules that are necessary to implement and administer
8 compliance, including rules describing the bona fide clinical
9 trials provided under paragraph (3) of subsection (d) of
10 Section 15 and the bona fide conferences provided under
11 paragraph (4) of subsection (d) of Section 15.
12     (b) If a manufacturer or labeler violates this Act, the
13 Director may bring an action in court for injunctive relief,
14 costs, attorney's fees, and a civil penalty of up to $10,000
15 per violation. Each unlawful failure to disclose shall
16 constitute a separate violation.
17     (c) Any civil penalties collected pursuant to this Section
18 shall be deposited into the Prescription Drug Ethical Marketing
19 Fund, which is hereby created as a special fund in the State
20 Treasury. The Prescription Drug Ethical Marketing Fund shall be
21 used, subject to appropriation, for the enforcement of this
22 Act.
 
23     Section 300. The State Finance Act is amended by adding
24 Section 5.719 as follows:
 

 

 

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1     (30 ILCS 105/5.719 new)
2     Sec. 5.719. The Prescription Drug Ethical Marketing Fund.