[Congressional Record Volume 149, Number 62 (Tuesday, April 29, 2003)]
[Senate]
[Pages S5494-S5495]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. SCHUMER:
  S. 948. 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; to the Committee on Health, Education, Labor, and Pensions.
  Mr. SCHUMER. Mr. President, I ask unanimous consent that the text of 
the bill be printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                 S. 948

       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

[[Page S5495]]

     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.''.
                                 ______