NIH and FDA leaders call for more research, lower barriers to improve and implement drug- checking tools amid overdose epidemic

Tools such as fentanyl test strips hold promise to reduce drug-related harms and save lives

In a new Commentary in the New England Journal of Medicine, leaders at the National Institutes of Health and U.S. Food and Drug Administration highlight the urgent need to address current gaps in the research, development, and implementation of fentanyl test strips and other rapid drug-detecting tools that could help prevent overdose deaths. These tools have the potential to save lives and to serve as an important part of harm reduction toolkits but often remain inaccessible because of gaps in research and various other barriers, including state or legal prohibitions. This call to action encourages new collaborations among researchers and agencies to ensure the effectiveness of fentanyl test strips and promote the development of additional drug-checking technologies. It also encourages the reduction of barriers that inhibit use of these technologies where not prohibited by law.

In 2021, more than 60,000 people in the U.S. ages 15 to 54 died from opioid-involved overdose – more than COVID-19 fatalities for this age group – and many of these deaths were driven by the extremely potent opioid fentanyl, which is difficult to detect unaided. Illicit fentanyl is being mixed with other drugs like heroin, cocaine, methamphetamine, xylazine and in counterfeit pills, leaving many people unaware of the specific substances they are consuming. Expanding access to innovative, inexpensive, and easy-to-use drug-checking technologies where not prohibited by law may be able to play a pivotal role to help keep people safe, whether at home or in public.

Fentanyl test strips are among the most well-known and easily distributable drug-checking tools to date, yet few studies have evaluated their performance and impact on public health. In general, the FDA does not regulate test products when intended solely for use to detect substances or adulterants in illicit drugs. It is critical for researchers and developers of these drug-detecting-products to evaluate their accuracy to assure quality and performance in each instance of use. Research is also needed to determine whether other drug checking strategies are feasible and effective in community and clinical settings and to develop techniques for detecting other emerging substances. Models for implementing drug checking strategies should ensure that they are deployed in an equitable and culturally appropriate way, tailored to unique community needs where not prohibited by law.

NIH welcomes research proposals on fentanyl test strips and other drug checking and screening tools. The FDA has provided premarket clearance for laboratory-based tests to detect fentanyl in urine and hair and welcomes the opportunity to work with manufacturers on point-of-care devices intended for testing human specimens. This would be particularly valuable in clinical settings to help monitor critical trends and outcomes and aid in clinical evaluations of substance use.

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