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 connec-
tion with detailing, promotional, or other marketing ac-
tivities, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Drug Company Gift 
Disclosure Act’’.
SEC. 2. DISCLOSURE BY PRESCRIPTION DRUG MANUFAC-
TURERS, PACKERS, AND DISTRIBUTORS OF 
CERTAIN GIFTS. 
Section 503 of the Federal Food, Drug, and Cos-
metics Act (21 U.S.C. 353) is amended by adding at the 
end the following: 
‘‘(h)(1) Each manufacturer, packer, or distributor of 
a drug subject to subsection (b)(1) shall disclose to the 
Commissioner— 
‘‘(A) not later than June 30, 2007, and each 
June 30 thereafter, the value, nature, and purpose 
of any— 
‘‘(i) gift provided during the preceding cal-
endar year to any covered health entity by the 
manufacturer, packer, or distributor, or a rep-
resentative thereof, in connection with detailing, 
promotional, or other marketing activities; and 
‘‘(ii) cash rebate, discount, or any other fi-
nancial consideration provided during the pre-
ceding calendar year to any pharmaceutical 
benefit manager by the manufacturer, packer, 
or distributor, or a representative thereof, in 
connection with detailing, promotional, or other 
marketing activities; and 
‘‘(B) not later than the date that is 6 months 
after the date of enactment of this subsection and
each June 30 thereafter, the name and address of 
the individual responsible for the compliance of the 
manufacturer, packer, or distributor with the provi-
sions of this subsection. 
‘‘(2) Subject to paragraph (3), the Commissioner 
shall make all information disclosed to the Commissioner 
under paragraph (1) publicly available, including by post-
ing such information on the Internet. 
‘‘(3) The Commissioner shall keep confidential any 
information disclosed to or otherwise obtained by the Com-
missioner under this subsection that relates to a trade se-
cret referred to in section 1905 of title 18, United States 
Code. The Commissioner shall provide an opportunity in 
the disclosure form required under paragraph (4) for a 
manufacturer, packer, or distributor to identify any such 
information. 
‘‘(4) Each disclosure under this subsection shall be 
made in such form and manner as the Commissioner may 
require. 
‘‘(5) Each manufacturer, packer, and distributor de-
scribed in paragraph (1) shall be subject to a civil mone-
tary penalty of not more than $10,000 for each violation 
of this subsection. Each unlawful failure to disclose shall 
constitute a separate violation. The provisions of para-
graphs (3), (4), and (5) of section 303(f) shall apply to
such a violation in the same manner as such provisions 
apply to a violation of a requirement of this Act that re-
lates to devices. 
‘‘(6) For purposes of this subsection: 
‘‘(A) The term ‘covered health entity’ includes 
any physician, hospital, nursing home, pharmacist, 
health benefit plan administrator, or any other per-
son authorized to prescribe or dispense drugs that 
are subject to subsection (b)(1), in the District of 
Columbia or any State, commonwealth, possession, 
or territory of the United States. 
‘‘(B) The term ‘gift’ includes any gift, fee, pay-
ment, subsidy, or other economic benefit with a 
value of $50 or more, except that such term excludes 
the following: 
‘‘(i) Free samples of drugs subject to sub-
section (b)(1) intended to be distributed to pa-
tients. 
‘‘(ii) The payment of reasonable compensa-
tion and reimbursement of expenses in connec-
tion with any bona fide clinical trial conducted 
in connection with a research study designed to 
answer specific questions about drugs, devices, 
new therapies, or new ways of using known 
treatments.
‘‘(iii) Any scholarship or other support for 
medical students, residents, or fellows selected 
by a national, regional, or specialty medical or 
other professional association to attend a sig-
nificant educational, scientific, or policy-making 
conference of the association.’’. 
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