Registration and Regulation Committee
Filed: 2/24/2005
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1 | AMENDMENT TO HOUSE BILL 656
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2 | AMENDMENT NO. ______. Amend House Bill 656 by replacing | ||||||
3 | everything after the enacting clause with the following:
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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. |
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1 | "Labeler" means an entity or person that receives | ||||||
2 | prescription drugs from a manufacturer or wholesaler
and | ||||||
3 | repackages those drugs for later retail sale and that has a | ||||||
4 | labeler code from the Food and Drug Administration under 21 | ||||||
5 | C.F. R. 207.20.
"Labeler" does not include a retail pharmacy or | ||||||
6 | pharmacist that labels a prescription vial. | ||||||
7 | "Manufacturer" means a manufacturer of prescription drugs | ||||||
8 | as defined in 42 U.S.C. 1396r-8
(k)(5), including a subsidiary | ||||||
9 | or affiliate of a manufacturer.
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10 | "Pharmaceutical marketer" means a person who, while | ||||||
11 | employed by or under contract to represent a
manufacturer or | ||||||
12 | labeler, engages in pharmaceutical detailing, promotional | ||||||
13 | activities, or other marketing of
prescription drugs in this | ||||||
14 | State to any physician, hospital, nursing home, pharmacist, | ||||||
15 | health benefit plan
administrator, or any other person | ||||||
16 | authorized to prescribe or dispense prescription drugs.
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17 | Section 15. Disclosure of marketing practices. | ||||||
18 | (a) On or before January 1 of each year, every manufacturer | ||||||
19 | and labeler that sells prescription drugs in the
State shall | ||||||
20 | disclose to the Director the name and address of the individual | ||||||
21 | responsible for the company's
compliance with the provisions of | ||||||
22 | this Section.
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23 | (b) On or before February 1 of each year, every | ||||||
24 | manufacturer and labeler that sells prescription drugs in the
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25 | State shall disclose to the Director the value, nature, and | ||||||
26 | purpose of any gift, fee, payment, subsidy, or other
economic | ||||||
27 | benefit provided in connection with detailing or promotional or | ||||||
28 | other marketing activities by the
company, directly or through | ||||||
29 | its pharmaceutical marketers, to any physician, hospital, | ||||||
30 | nursing home,
health benefit plan administrator, or any other | ||||||
31 | person in Illinois authorized to prescribe prescription drugs. | ||||||
32 | Disclosure shall cover the prior year and it shall be made on a | ||||||
33 | form
and in a manner prescribed by the Director.
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1 | (c) On or before March 1 of each year, the Director shall | ||||||
2 | report to the Governor and the General Assembly on the | ||||||
3 | disclosures made under this Section. | ||||||
4 | (d) The following shall be exempt from disclosure:
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5 | (1) Any gift, fee, payment, subsidy or other economic | ||||||
6 | benefit, the value of which is less than 25 dollars.
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7 | (2) Free samples of prescription drugs to be | ||||||
8 | distributed to patients.
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9 | (3) The payment of reasonable compensation and | ||||||
10 | reimbursement of expenses in connection with a bona
fide | ||||||
11 | clinical trial conducted in connection with a research | ||||||
12 | study designed to answer specific questions
about | ||||||
13 | vaccines, new therapies, or new ways of using known | ||||||
14 | treatments.
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15 | (4) Scholarship or other support for medical students, | ||||||
16 | residents, and fellows to attend a bona fide educational,
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17 | scientific, or policy-making conference of an established | ||||||
18 | professional association if the recipient of
the | ||||||
19 | scholarship or other support is selected by the | ||||||
20 | association. | ||||||
21 | Section 20. Administration and enforcement. | ||||||
22 | (a) This Act shall be enforced by the Director, who shall | ||||||
23 | adopt any rules that are necessary
to implement and administer | ||||||
24 | compliance, including rules describing the bona fide clinical | ||||||
25 | trials provided under paragraph (3) of subsection (d) of | ||||||
26 | Section 15 and the bona fide conferences provided under | ||||||
27 | paragraph (4) of subsection (d) of Section 15. | ||||||
28 | (b) If a manufacturer or labeler violates this Act, the | ||||||
29 | Director may bring an action in court for injunctive
relief, | ||||||
30 | costs, attorney's fees, and a civil penalty of up to $10,000 | ||||||
31 | per violation. Each unlawful failure to
disclose shall | ||||||
32 | constitute a separate violation.".
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