Regulators at the United States Food and Drug Administration (FDA), as well as physicians, pharmacists, and drug company representatives, all knew that existing safeguards were not stopping the illicit spread of the powerful synthetic opioid fentanyl, according to research published in JAMA Network on Tuesday. This allowed people who should not have had access to the drug, which is 50 to 100 times as potent as morphine and often laced with or sold as heroin, to get it. Overall, the study authors concluded that 34.6% to 55.4% of those prescribed the drug should not have been.
The analysis was based on 4,877 pages of FDA documents that were obtained through a Freedom of Information Act (FOIA) request. As the Washington Post notes, a FOIA request is an unusual aspect of this medical journal paper, which is more commonly based on a controlled study rather than qualitative analysis of records. But this study, which looks at how safeguards failed to keep the highly addictive painkiller from becoming widely available, shows the necessity for strict measures to keep the potent drug from the general public.
Fentanyl’s widespread use and misuse has been noted in recent months. In 2018, fentanyl was responsible for more than half of all overdose deaths, a striking uptick. The painkiller is so powerful, the Drug Enforcement Agency (DEA) even issued new guidelines for first responders that might encounter a fentanyl-related overdose, noting they could be fatally exposed if they come in contact with even a tiny amount of the substance.