This part orders a report from the drug agency. The report must lay out a plan for looking at opioid pain drugs. It must cover safety, labels and next steps. The public gets a chance to weigh in.
The document says “shall”Who acts: Secretary of Health and Human ServicesHow: statuteSec. 112 in the PDF
What the document says
“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”
The section directs the Secretary to publish, within one year of enactment, a report on the FDA website outlining a plan for assessing approved opioid analgesic drugs. The plan must address the public health effects of those drugs as part of the benefit and risk assessment, and the agency's work on developing nonaddictive products to treat pain or addiction.
What the document actually says
“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 sentence, in plain words
The Secretary must put out a report within one year. It goes on the drug agency website. It lays out a plan for checking opioid pain drugs.
What this is about
An opioid analgesic is a strong pain pill. The plan must weigh good against harm. It must also cover pain drugs that do not hook people.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “shall”Who acts: Secretary of Health and Human ServicesHow: statuteSec. 112 in the PDF
What the document says
“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”
The section lists four contents for the report: an update on actions the FDA has taken on the effectiveness, safety, benefit and risk profile and use of approved opioid analgesic drugs; a timeline for assessing possible labeling changes, postmarketing requirements, enforcement actions or withdrawals; an overview of steps taken to support nonaddictive products; and an overview of the agency's consideration of clinical trial methods.
What the document actually says
“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”
That sentence, in plain words
The report must set out a schedule. The schedule covers checks on what may need to change. Labels, extra safety studies, or even pulling a drug are all on that list.
What this is about
A postmarket study is done after a drug goes on sale. Withdrawal means pulling a drug off the market. The report only sets a schedule for looking at these.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “shall”Who acts: Secretary of Health and Human ServicesHow: statuteSec. 112 in the PDF
What the document says
“In carrying out subsection (a), the Secretary shall provide an opportunity for public input concerning the regulation by the FDA of opioid analgesic drugs”
The section requires the Secretary to provide an opportunity for public input on the FDA's regulation of opioid analgesic drugs, including scientific evidence relating to conditions of use, safety, or the benefit and risk assessment.
What the document actually says
“In carrying out subsection (a), the Secretary shall provide an opportunity for public input concerning the regulation by the FDA of opioid analgesic drugs”
That sentence, in plain words
The Secretary must let the public speak. People can weigh in on how these drugs are handled. That input feeds the report.
What this is about
Public input means anyone can send in a view. Doctors, patients and drug makers all can. The law asks for science on how the drugs are used and how safe they are.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
Reauthorize certain programs that provide for opioid use disorder prevention, treatment, and recovery, Public Law 119-44, sec. 112, 139 Stat. 679 (2025). https://www.govinfo.gov/content/pkg/PLAW-119publ44/html/PLAW-119publ44.htm
This page
“Assessment of Opioid Drugs and Actions,” Reauthorize certain programs that provide for opioid use disorder prevention, treatment, and recovery, section 112. Read the Mandate, https://readthemandate.org/pl-119-44/section-112/ (retrieved August 26, 2026).
Cite the document when the claim is about what the document says. Cite this page when the indexing, the wording or the record of what has happened is what is being relied on.
What This Page Covers, and What It Leaves Out
The two things the section requires: the report the Secretary must publish and its four listed contents, and the opportunity for public input.
Nothing. The section has two subsections and both are recorded here.
The section amends no older statute. It refers to section 505 of the Federal Food, Drug, and Cosmetic Act, which is not indexed here, so nothing is recorded about how a drug is approved under it.
