Full Text of HB0656 94th General Assembly
HB0656ham001 94TH GENERAL ASSEMBLY
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Registration and Regulation Committee
Filed: 2/24/2005
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09400HB0656ham001 |
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LRB094 04107 RXD 40949 a |
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| AMENDMENT TO HOUSE BILL 656
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| AMENDMENT NO. ______. Amend House Bill 656 by replacing | 3 |
| everything after the enacting clause with the following:
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| "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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| (1) Prescription drug spending is the fastest growing | 9 |
| component of health care spending in the United
States.
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| (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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| (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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| "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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| "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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| 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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| (b) On or before February 1 of each year, every | 24 |
| manufacturer and labeler that sells prescription drugs in the
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| 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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| (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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| (1) Any gift, fee, payment, subsidy or other economic | 6 |
| benefit, the value of which is less than 25 dollars.
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| (2) Free samples of prescription drugs to be | 8 |
| distributed to patients.
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| (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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| (4) Scholarship or other support for medical students, | 16 |
| residents, and fellows to attend a bona fide educational,
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| 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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