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1 | AN ACT concerning prescription drugs.
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2 | Be it enacted by the People of the State of Illinois,
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3 | represented in the General Assembly:
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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:
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8 | (1) Prescription drug spending is the fastest growing | ||||||||||||||||||||||||
9 | component of health care spending in the United
States.
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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.
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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: | ||||||||||||||||||||||||
23 | "Director" means the Director of Public Health. | ||||||||||||||||||||||||
24 | "Labeler" means an entity or person that receives | ||||||||||||||||||||||||
25 | prescription drugs from a manufacturer or wholesaler
and | ||||||||||||||||||||||||
26 | repackages those drugs for later retail sale and that has a | ||||||||||||||||||||||||
27 | labeler code from the Food and Drug Administration under 21 | ||||||||||||||||||||||||
28 | C.F. R. 207.20.
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29 | "Manufacturer" means a manufacturer of prescription drugs | ||||||||||||||||||||||||
30 | as defined in 42 U.S.C. 1396r-8
(k)(5), including a subsidiary | ||||||||||||||||||||||||
31 | or affiliate of a manufacturer.
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1 | "Pharmaceutical marketer" means a person who, while | ||||||
2 | employed by or under contract to represent a
manufacturer or | ||||||
3 | labeler, engages in pharmaceutical detailing, promotional | ||||||
4 | activities, or other marketing of
prescription drugs in this | ||||||
5 | State to any physician, hospital, nursing home, pharmacist, | ||||||
6 | health benefit plan
administrator, or any other person | ||||||
7 | authorized to prescribe or dispense prescription drugs.
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8 | Section 15. Disclosure of marketing practices. | ||||||
9 | (a) On or before January 1 of each year, every manufacturer | ||||||
10 | and labeler that sells prescription drugs in the
State shall | ||||||
11 | disclose to the Director the name and address of the individual | ||||||
12 | responsible for the company's
compliance with the provisions of | ||||||
13 | this Section.
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14 | (b) On or before February 1 of each year, every | ||||||
15 | manufacturer and labeler that sells prescription drugs in the
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16 | State shall disclose to the Director the value, nature, and | ||||||
17 | purpose of any gift, fee, payment, subsidy, or other
economic | ||||||
18 | benefit provided in connection with detailing or promotional or | ||||||
19 | other marketing activities by the
company, directly or through | ||||||
20 | its pharmaceutical marketers, to any physician, hospital, | ||||||
21 | nursing home,
pharmacist, health benefit plan administrator, | ||||||
22 | or any other person in Illinois authorized to prescribe or
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23 | dispense prescription drugs. Disclosure shall cover the prior | ||||||
24 | year and disclosure shall be made on a form
and in a manner | ||||||
25 | prescribed by the Director.
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26 | (c) On or before March 1 of each year, the Director shall | ||||||
27 | report to the Governor and the General Assembly on the | ||||||
28 | disclosures made under this Section. | ||||||
29 | (d) The following shall be exempt from disclosure:
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30 | (1) Any gift, fee, payment, subsidy or other economic | ||||||
31 | benefit the value of which is less than 25 dollars.
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32 | (2) Free samples of prescription drugs to be | ||||||
33 | distributed to patients.
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34 | (3) The payment of reasonable compensation and | ||||||
35 | reimbursement of expenses in connection with a bona
fide |
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1 | clinical trial conducted in connection with a research | ||||||
2 | study designed to answer specific questions
about | ||||||
3 | vaccines, new therapies, or new ways of using known | ||||||
4 | treatments.
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5 | (4) Scholarship or other support for medical students, | ||||||
6 | residents, and fellows to attend a bona fide educational,
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7 | scientific, or policy-making conference of an established | ||||||
8 | professional association if the recipient of
the | ||||||
9 | scholarship or other support is selected by the | ||||||
10 | association. | ||||||
11 | Section 20. Administration and enforcement. | ||||||
12 | (a) This Act shall be enforced by the Director, who shall | ||||||
13 | adopt any rules that are necessary
to implement and administer | ||||||
14 | compliance, including rules describing bona fide clinical | ||||||
15 | trials in
item (3) of subsection (d) of Section 15 and bona | ||||||
16 | fide conferences in item (4) of subsection (d) of Section 15. | ||||||
17 | (b) If a manufacturer or labeler violates this Act, the | ||||||
18 | Director may bring an action in court for injunctive
relief, | ||||||
19 | costs, attorneys fees, and a civil penalty of up to $10,000 per | ||||||
20 | violation. Each unlawful failure to
disclose shall constitute a | ||||||
21 | separate violation.
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