[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5037 Introduced in House (IH)]







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 Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 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 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
            ``(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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