I 
110TH CONGRESS 
1ST SESSION H. R. 3023 
To require the manufacturers, packers, and distributors of prescription drugs 
and medical devices to disclose certain gifts provided in connection with 
detailing, promotional, or other marketing activities, and for other pur-
poses. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 12, 2007 
Mr. DEFAZIO (for himself, Mr. STARK, Mr. WAXMAN, Mr. CHANDLER, and 
Mr. HINCHEY) introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To require the manufacturers, packers, and distributors of 
prescription drugs and medical devices to disclose certain 
gifts provided in connection with detailing, promotional, 
or other marketing activities, 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 and Medical De-
vice Company Gift Disclosure Act’’. 
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SEC. 2. DISCLOSURE OF CERTAIN GIFTS BY MANUFACTUR-
ERS, PACKERS, AND DISTRIBUTORS OF PRE-
SCRIPTION DRUGS AND MEDICAL DEVICES. 
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) or of a device 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, directly or indirectly, 
during the preceding calendar year to any cov-
ered health entity by the manufacturer, packer, 
or distributor, or a representative or agent 
thereof, in connection with detailing, pro-
motional, 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 or agent 
thereof, in connection with detailing, pro-
motional, or other marketing activities; and 
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‘‘(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) Each disclosure under this subsection shall be 
made in such form and manner as the Commissioner may 
require. 
‘‘(3) For purposes of this subsection: 
‘‘(A) The term ‘covered health entity’ includes, 
but is not limited to, any physician, nurse, therapist, 
hospital, nursing home, pharmacist, health benefit 
plan administrator, or any other person 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. Such term includes an individual who 
is not directly employed by the drug or device manu-
facturer, packer, distributor, representative, or 
agent. 
‘‘(B) The term ‘gift’ includes any gift, fee, pay-
ment, subsidy, amenity, object, service or other eco-
nomic benefit, except that such term excludes the 
following: 
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‘‘(i) Free samples of drugs subject to sub-
section (b)(1) intended to be distributed to pa-
tients free of charge. 
‘‘(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. 
‘‘(4) With respect to gifts, paragraph (1) shall only 
apply if the total value of any gift or gifts provided during 
the applicable calendar year is fifty dollars or more. 
‘‘(5) Subject to paragraph (6), the Commissioner 
shall make all information disclosed to the Commissioner 
under paragraph (1) publicly available, including by post-
ing such information on the Internet. 
‘‘(6) The Commissioner shall keep confidential any 
information disclosed to or otherwise obtained by the Com-
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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 (2) for a 
manufacturer, packer, or distributor to identify any such 
information. 
‘‘(7) Each manufacturer, packer, or 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. 
‘‘(8)(A) The Commissioner shall have authority to in-
vestigate compliance with this subsection. 
‘‘(B) If, after carrying out an investigation under this 
paragraph, the Commissioner has reasonable cause to be-
lieve that a report required under this subsection has not 
been filed in accordance with the provisions of this section, 
the Commissioner may petition the United States District 
Court in which the responsible party resides or transacts 
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business, for an order requiring submission of a report and 
such other relief as the Court considers appropriate.’’. 
Æ 
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