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.
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
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.
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.'.
U.S. Congress - Text of H.R.3023 as Introduced in House Drug and Medical Device Company Gift Disclosure Act
