Sec. 6. Making prescription drug marketing sample information reported by manufacturers available to certain individuals and entities
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Section 1128H of the Social Security Act ( 42 U.S.C. 1320a–7i ) is amended— by redesignating subsection
(b)as subsection (e); and by inserting after subsection
(a)the following new subsections: The Secretary shall enter into agreements with the specified data sharing individuals and entities described in paragraph
(2)under which— upon request of such an individual or entity, as applicable, the Secretary makes available to such individual or entity the information submitted under subsection
(a)by manufacturers and authorized distributors of record; and such individual or entity agrees to not disclose publicly or to another individual or entity any information that identifies a particular practitioner or health care facility. For purposes of paragraph (1), the specified data sharing individuals and entities described in this paragraph are the following: Health oversight agencies (as defined in section 164.501 of title 45, Code of Federal Regulations), including the Centers for Medicare & Medicaid Services, the Office of the Inspector General of the Department of Health and Human Services, the Government Accountability Office, the Congressional Budget Office, the Medicare Payment Advisory Commission, and the Medicaid and CHIP Payment and Access Commission. Individuals who conduct scientific research (as defined in section 164.501 of title 45, Code of Federal Regulations) in relevant areas as determined by the Secretary. Private and public health care payers, including group health plans, health insurance coverage offered by health insurance issuers, Federal health programs, and State health programs. Except as described in paragraph (1), the Secretary may not be compelled to disclose the information submitted under subsection
(a)to any individual or entity. For purposes of section 552 of title 5, United States Code (commonly referred to as the Freedom of Information Act), this paragraph shall be considered a statute described in subsection (b)(3)(B) of such section. Subject to paragraph (3), any specified data sharing individual or entity described in subsection (b)(2) that violates the terms of a data sharing agreement the individual or entity has with the Secretary under subsection (b)(1) shall be subject to a civil money penalty of not less than $1,000, but not more than $10,000, for each such violation. Such penalty shall be imposed and collected in the same manner as civil money penalties under subsection
(a)of section 1128A are imposed and collected under that section. Subject to paragraph (3), any manufacturer or authorized distributor of record of an applicable drug under subsection
(a)that fails to submit information required under such subsection in a timely manner in accordance with rules or regulations promulgated to carry out such subsection shall be subject to a civil money penalty of not less than $1,000, but not more than $10,000, for each such failure. Such penalty shall be imposed and collected in the same manner as civil money penalties under subsection
(a)of section 1128A are imposed and collected under that section. The total amount of civil money penalties imposed under paragraph
(1)or
(2)with respect to a year and an individual or entity described in subparagraph
(A)or a manufacturer or distributor described in subparagraph (B), respectively, shall not exceed $150,000. Not later than January 1 of each year (beginning with 2021), the Secretary shall maintain a list containing information related to the distribution of samples of applicable drugs. Such list shall provide the following information with respect to the preceding year: The name of the manufacturer or authorized distributor of record of an applicable drug for which samples were requested or distributed under this section. The quantity and class of drug samples requested. The quantity and class of drug samples distributed. The Secretary shall make the information in such list available to the public on the Internet Web site of the Food and Drug Administration. . The Food and Drug Administration shall maintain information available to affected reporting companies to ensure their ability to fully comply with the requirements of section 1128H of the Social Security Act. Section 503(d) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353(d) ) is amended— by moving the margin of paragraph
(4)2 ems to the left; and by adding at the end the following: No person may distribute a drug sample of a drug that is— an applicable drug (as defined in section 1128H(d) of the Social Security Act); a controlled substance (as defined in section 102 of the Controlled Substances Act) for which the findings required under section 202(b)(2) of such Act have been made; and approved under section 505 for use in the management or treatment of pain (other than for the management or treatment of a substance use disorder). . Not later than 3 years after the date of the enactment of this Act, the Medicare Payment Advisory Commission shall conduct a study on the impact of drug samples on provider prescribing practices and health care costs and may, as the Commission deems appropriate, make recommendations on such study.
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- 42 USC 1320a–7i
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Sec. 6
Making prescription drug marketing sample information reported by manufacturers available to certain individuals and entities
Cite42 USC 1320a–7i
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