[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 948 Introduced in Senate (IS)]
108th CONGRESS
1st Session
S. 948
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 SENATE OF THE UNITED STATES
April 29, 2003
Mr. Schumer introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
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.
Be it enacted by the Senate and House of Representatives 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 MANUFACTURERS, PACKERS, AND
DISTRIBUTORS OF CERTAIN GIFTS.
Section 503 of the Federal Food, Drug, and Cosmetics 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--
``(i) gift provided during the preceding calendar
year to any covered health entity by the manufacturer,
packer, or distributor, or a representative thereof, in
connection with detailing, promotional, or other
marketing activities; and
``(ii) cash rebate, discount, or any other
financial consideration provided during the preceding
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 provisions 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 posting such information on the Internet.
``(3) The Commissioner shall keep confidential any information
disclosed to or otherwise obtained by the Commissioner under this
subsection that relates to a trade secret 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 described in
paragraph (1) shall be subject to a civil monetary 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 paragraphs (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 relates 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 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.
``(B) The term `gift' includes any gift, fee, payment,
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 subsection
(b)(1) intended to be distributed to patients.
``(ii) The payment of reasonable compensation and
reimbursement of expenses in connection 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 significant
educational, scientific, or policy-making conference of
the association.''.
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