Sec. 4125. Safe harbor provision
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/bill/116/s/3548/is/section-4125·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
The Federal Food, Drug, and Cosmetic Act is amended by inserting after section 502 ( 21 U.S.C. 352 ) the following: The communication of information, consistent with subsection (b), with respect to the use of a drug or device authorized under section 564 provided or distributed to a health care provider, shall not— be a basis for treating such drug or device as misbranded under subsection
(a)or
(f)of section 502, or in violation of section 505, 515, or 564 of this Act or subsection
(a)or
(k)of section 351(a)(1) of the Public Health Service Act, as applicable; or be treated as evidence that such drug or device is misbranded under subsection
(a)or
(f)of section 502, or in violation of section 505, 513, 515, or 564 of this Act or subsection
(a)or
(k)of section 351 of the Public Health Service Act, as applicable. Any information relating to a use of a drug or device authorized under section 564, or for which a submission under section 564 has been submitted, that— is neither false nor misleading, when measured objectively against the information available at the time the statement is made; is accompanied, as required, by an appropriate disclaimer, as described in paragraph (2); and is based on competent and reliable scientific evidence, as described in subsection (c). For purposes of paragraph (1), such information shall be accompanied, as necessary, by an appropriate disclaimer, including— a statement identifying any differences between the information and any labeling of the drug or device; a statement identifying contradictory evidence; and such other information as may be required by regulation. In this section, the term competent and reliable scientific evidence means evidence established through scientific methods that are widely accepted by experts in the relevant field and followed pursuant to a clear and well-described protocol, as scientifically appropriate. Evidence may constitute competent and reliable scientific evidence within the meaning of this section— regardless of whether it is supported by 2 adequate and well-controlled clinical studies; and may include— information derived from clinical trials, observational studies, clinical studies or bench tests that describe performance, database reviews, registries, patient utilization projections, and modeling techniques, and the data, inputs, and components of such information; information about the effects of a drug or device in subgroups defined by demographic or other variables, including groups defined by race, sex, risk factors, or other variables, such as genomic features or disease severity; information related to the emergency use authorization, as applicable; and information relating to the safety, effectiveness, or benefit of a use or treatment that is authorized under section 564 for a drug or device, including information regarding— health outcomes, patient or caregiver experience, or other quality metrics; and the comparative effectiveness of a drug or device relative to others products, other health care interventions, program and quality improvement interventions, or no intervention. Information pursuant to subsection
(b)may be distributed proactively through written or oral means, or other information platforms, to a health care provider, payor, formulary committee, or other similar entity carrying out responsibilities for making drug coverage, reimbursement, or usage decisions on a population basis. The distribution of information that otherwise meets the requirements of this section shall not fail to meet the requirements of subsection
(a)because the manufacturer or distributor of the drug or device about which information is being distributed has— knowledge that such drug or device is being used by patients or health care practitioners in a manner not described in any labeling of the drug or device, as applicable; or objective or subjective intent that such drug or device be used in a manner inconsistent with any labeling, as applicable, of such drug or device. Nothing in this section shall be construed— to limit communication not specifically permitted by this section; or to alter or expand the authority of the Secretary to enforce the provisions of this Act, except to the extent that the communication of information in accordance with this section is permitted. .
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Sec. 4125
Safe harbor provision
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