Sec. 3002. Evidence-based opioid analgesic prescribing guidelines and report
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The Commissioner of Food and Drugs shall develop evidence-based opioid analgesic prescribing guidelines for the indication-specific treatment of acute pain only for the relevant therapeutic areas where such guidelines do not exist. In developing the guidelines under subsection (a), the Commissioner of Food and Drugs shall— consult with stakeholders, which may include conducting a public meeting of medical professional societies (including any State-based societies), health care providers, State medical boards, medical specialties including pain medicine specialty societies, patient groups, pharmacists, academic or medical research entities, and other entities with experience in health care, as appropriate; collaborate with the Director of the Centers for Disease Control and Prevention, as applicable and appropriate, and other Federal agencies with relevant expertise as appropriate; and provide for a notice and comment period consistent with section 701(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 371(h) ) for the submission of comments by the public.
Not later than 1 year after the date of enactment of this Act, or, if earlier, at the time the guidelines under subsection
(a)are finalized, the Commissioner of Food and Drugs shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate, and post on the public website of the Food and Drug Administration, a report on how the Food and Drug Administration will utilize the guidelines under subsection
(a)to protect the public health and a description of the public health need with respect to each such indication-specific treatment guideline. The Commissioner of Food and Drugs shall periodically— update the guidelines under subsection (a), informed by public input described in subsection (b); and submit to the committees specified in subsection
(c)and post on the public website of the Food and Drug Administration an updated report under such subsection. The Commissioner of Food and Drugs shall ensure that opioid analgesic prescribing guidelines and other recommendations developed under this section are accompanied by a clear statement that such guidelines or recommendations, as applicable— are intended to help inform clinical decisionmaking by prescribers and patients; and are not intended to be used for the purposes of restricting, limiting, delaying, or denying coverage for, or access to, a prescription issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice.
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Sec. 3002
Evidence-based opioid analgesic prescribing guidelines and report
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