I
107TH CONGRESS
2D SESSION
H. R. 5037
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
JUNE 27, 2002
Mr. DEFAZIO (for himself, Mr. BROWN of Ohio, Mr. STARK, Mr. GEORGE
MILLER of California, Mr. CROWLEY, Mr. FILNER, Ms. WOOLSEY, Mr.
JACKSON of Illinois, Ms. NORTON, Ms. ROYBAL-ALLARD, and Mr.
DOGGETT) introduced the following bill; which was referred to the Com-
mittee 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, 2004, and each
June 30 thereafter, the value, nature, and purpose
of any gift provided during the preceding calendar
year to any covered health entity by the manufac-
turer, 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(g) 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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