I 

109TH CONGRESS 

2D SESSION H. R. 4718 

To require prescription drug manufacturers, packers, and distributors to 

disclose certain gifts provided in connection with detailing, promotional, 

or other marketing activities, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 8, 2006 

Mr. DEFAZIO introduced the following bill; which was referred to the 

Committee on Energy and Commerce 

A BILL 

To require prescription drug manufacturers, packers, and 

distributors to disclose certain gifts provided in connection with detailing, promotional, or other marketing activities, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Drug Company Gift 

5 Disclosure Act’’. 
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1 SEC. 2. DISCLOSURE BY PRESCRIPTION DRUG MANUFAC2 TURERS, PACKERS, AND DISTRIBUTORS OF 

3 CERTAIN GIFTS. 

4 Section 503 of the Federal Food, Drug, and Cos5 metics Act (21 U.S.C. 353) is amended by adding at the 

6 end the following: 

7 ‘‘(h)(1) Each manufacturer, packer, or distributor of 

8 a drug subject to subsection (b)(1) shall disclose to the 

9 Commissioner— 

10 ‘‘(A) not later than June 30, 2007, and each 

11 June 30 thereafter, the value, nature, and purpose 

12 of any— 

13 ‘‘(i) gift provided during the preceding cal14 endar year to any covered health entity by the 

15 manufacturer, packer, or distributor, or a rep16 resentative thereof, in connection with detailing, 

17 promotional, or other marketing activities; and 

18 ‘‘(ii) cash rebate, discount, or any other fi19 nancial consideration provided during the pre20 ceding calendar year to any pharmaceutical 

21 benefit manager by the manufacturer, packer, 

22 or distributor, or a representative thereof, in 

23 connection with detailing, promotional, or other 

24 marketing activities; and 

25 ‘‘(B) not later than the date that is 6 months 

26 after the date of enactment of this subsection and 
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1 each June 30 thereafter, the name and address of 

2 the individual responsible for the compliance of the 

3 manufacturer, packer, or distributor with the provi4 sions of this subsection. 

5 ‘‘(2) Subject to paragraph (3), the Commissioner 

6 shall make all information disclosed to the Commissioner 

7 under paragraph (1) publicly available, including by post8 ing such information on the Internet. 

9 ‘‘(3) The Commissioner shall keep confidential any 

10 information disclosed to or otherwise obtained by the Com11 missioner under this subsection that relates to a trade se12 cret referred to in section 1905 of title 18, United States 

13 Code. The Commissioner shall provide an opportunity in 

14 the disclosure form required under paragraph (4) for a 

15 manufacturer, packer, or distributor to identify any such 

16 information. 

17 ‘‘(4) Each disclosure under this subsection shall be 

18 made in such form and manner as the Commissioner may 

19 require. 

20 ‘‘(5) Each manufacturer, packer, and distributor de21 scribed in paragraph (1) shall be subject to a civil mone22 tary penalty of not more than $10,000 for each violation 

23 of this subsection. Each unlawful failure to disclose shall 

24 constitute a separate violation. The provisions of para25 graphs (3), (4), and (5) of section 303(f) shall apply to 
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1 such a violation in the same manner as such provisions 

2 apply to a violation of a requirement of this Act that re3 lates to devices. 

4 ‘‘(6) For purposes of this subsection: 

5 ‘‘(A) The term ‘covered health entity’ includes 

6 any physician, hospital, nursing home, pharmacist, 

7 health benefit plan administrator, or any other per8 son authorized to prescribe or dispense drugs that 

9 are subject to subsection (b)(1), in the District of 

10 Columbia or any State, commonwealth, possession, 

11 or territory of the United States. 

12 ‘‘(B) The term ‘gift’ includes any gift, fee, pay13 ment, subsidy, or other economic benefit with a 

14 value of $50 or more, except that such term excludes 

15 the following: 

16 ‘‘(i) Free samples of drugs subject to sub17 section (b)(1) intended to be distributed to pa18 tients. 

19 ‘‘(ii) The payment of reasonable compensa20 tion and reimbursement of expenses in connec21 tion with any bona fide clinical trial conducted 

22 in connection with a research study designed to 

23 answer specific questions about drugs, devices, 

24 new therapies, or new ways of using known 

25 treatments. 
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1 ‘‘(iii) Any scholarship or other support for 

2 medical students, residents, or fellows selected 

3 by a national, regional, or specialty medical or 

4 other professional association to attend a sig5 nificant educational, scientific, or policy-making 

6 conference of the association.’’. 

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