[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3023 Introduced in House (IH)]







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 purposes.


_______________________________________________________________________


                    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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Drug and Medical Device Company Gift 
Disclosure Act''.

SEC. 2. DISCLOSURE OF CERTAIN GIFTS BY MANUFACTURERS, PACKERS, AND 
              DISTRIBUTORS OF PRESCRIPTION DRUGS AND MEDICAL DEVICES.

    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) 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 covered health 
                entity by the manufacturer, packer, or distributor, or 
                a representative or agent 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 or agent 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) 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 manufacturer, packer, 
        distributor, representative, or agent.
            ``(B) The term `gift' includes any gift, fee, payment, 
        subsidy, amenity, object, service or other economic benefit, 
        except that such term excludes the following:
                    ``(i) Free samples of drugs subject to subsection 
                (b)(1) intended to be distributed to patients free of 
                charge.
                    ``(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.
    ``(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 posting such information on the Internet.
    ``(6) 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 (2) for a 
manufacturer, packer, or distributor to identify any such information.
    ``(7) Each manufacturer, packer, or 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(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 relates to devices.
    ``(8)(A) The Commissioner shall have authority to investigate 
compliance with this subsection.
    ``(B) If, after carrying out an investigation under this paragraph, 
the Commissioner has reasonable cause to believe 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 business, for an order requiring submission of a report and 
such other relief as the Court considers appropriate.''.
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