Registration and Regulation Committee

Filed: 2/24/2005

 

 


 

 


 
09400HB0656ham001 LRB094 04107 RXD 40949 a

1
AMENDMENT TO HOUSE BILL 656

2     AMENDMENT NO. ______. Amend House Bill 656 by replacing
3 everything after the enacting clause with the following:
 
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:
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.
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.
 
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.
23     (b) On or before February 1 of each year, every
24 manufacturer and labeler that sells prescription drugs in the
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:
5         (1) Any gift, fee, payment, subsidy or other economic
6     benefit, the value of which is less than 25 dollars.
7         (2) Free samples of prescription drugs to be
8     distributed to patients.
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.
15         (4) Scholarship or other support for medical students,
16     residents, and fellows to attend a bona fide educational,
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.".