Sec. 112. ASSESSMENT OF OPIOID DRUGS AND ACTIONS
325 words·~1 min read·
/statute-compilations/comps-18296/sec-112A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
## SEC. 112 ASSESSMENT OF OPIOID DRUGS AND ACTIONS ###
(a)In General Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall publish on the website of the Food and Drug Administration (referred to in this section as the “FDA”) a report that outlines a plan for assessing opioid analgesic drugs that are approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) that addresses the public health effects of such opioid analgesic drugs as part of the benefit-risk assessment and the activities of the FDA that relate to facilitating the development of nonaddictive medical products intended to treat pain or addiction. Such report shall include— ####
(1)an update on the actions taken by the FDA to consider the effectiveness, safety, benefit-risk profile, and use of approved opioid analgesic drugs; ####
(2)a timeline for an assessment of the potential need, as appropriate, for labeling changes, revised or additional postmarketing requirements, enforcement actions, or withdrawals for opioid analgesic drugs; ####
(3)an overview of the steps that the FDA has taken to support the development and approval of nonaddictive medical products intended to treat pain or addiction, and actions planned to further support the development and approval of such products; and ####
(4)an overview of the consideration by the FDA of clinical trial methodologies for analgesic drugs, including the enriched enrollment randomized withdrawal methodology, and the benefits and drawbacks associated with different trial methodologies for such drugs, incorporating any public input received under subsection (b). ###
(b)Public Input In carrying out subsection (a), the Secretary shall provide an opportunity for public input concerning the regulation by the FDA of opioid analgesic drugs, including scientific evidence that relates to conditions of use, safety, or benefit-risk assessment (including consideration of the public health effects) of such opioid analgesic drugs.
Connectionstraces to 1
Traces to 1 document
U.S. Code
Citation graph
cites case law
Sec. 112
ASSESSMENT OF OPIOID DRUGS AND ACTIONS
Cites 1Cited by 0 across 0 sources