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1 1 (August 11, 2023)

handle is hein.crs/govemmr0001 and id is 1 raw text is: S Congressional ____ 'aResearch Service Clinical Fentanyl Testing August 11, 2023 The opioid crisis in the United States is exacerbated by both the ubiquity and potency of fentanyl, a synthetic opioid that is up to 50 times stronger than heroin and 100 times stronger than morphine. Fentanyl is commonly mixed surreptitiously with other illicit drugs-such as heroin, cocaine, and methamphetamine-and thus is often taken unknowingly, which has driven an increase in opioid overdoses in recent years. The CDC estimates that there were about 110,000 drug overdose deaths in 2022, and of those, roughly 75% were due to fentanyl or other synthetic opioids. Clinical testing for fentanyl plays an important role in identifying individuals who may have unknowingly ingested fentanyl, allowing for adjustments to clinical treatment, as well as arrangement for appropriate supportive interventions. It also facilitates identifying if fentanyl is a causative agent in an active overdose, even if the patient knowingly took fentanyl, but is non-responsive. On a population level, this testing would facilitate monitoring trends of illicit drug use across and within geographic areas, as well as evaluating relevant health outcomes and their correlation with clinical presentation and treatment. There has been discussion within the public health community about distribution and use of fentanyl test strips, which are touted for their harm reduction potential, to test samples of street drugs for the presence of fentanyl prior to ingestion or use. Test strips for this purpose do not meet the definition of device under the Federal Food, Drug, and Cosmetic Act (FFDCA), and therefore are not regulated by the Food and Drug Administration (FDA). This type of visually-read fentanyl test strip may not currently be used in clinical settings, to guide clinical treatment. For a test to be commercialized and used in clinical settings, it generally needs to receive premarket authorization (e.g., 510(k) clearance) from the FDA and be carried out in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory (or CLIA waived setting for waived tests). FDA has stated that it would welcome an opportunity to work with in vitro diagnostic (IVD) developers to bring fentanyl test strips intended for testing human specimens in clinical settings to market, noting that this is an urgent public health gap. Regulation of Clinical Fentanyl Tests Two regulatory oversight mechanisms are relevant for clinical fentanyl testing: FDA regulation of the tests themselves, if they are commercialized; and CLIA certification of laboratories that carry out this testing. CLIA is also relevant for laboratory-developed fentanyl tests (e.g., LDTs)-that is, for LDTs that are developed and carried out within a single clinical laboratory, which have traditionally been regulated Congressional Research Service https://crsreports.congress.gov IN12219 CRS INSIGHT Prepared for Members and Committees of Congress

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