ICYMI: FDA Evaluating Packaging Changes to Immediate-Release Opioid Analgesics
The FDA announced last month that it is evaluating the public health and safety impact of modifying the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) to have fixed-quantity blister-packaging. This would be for opioid analgesics used in treating acute pain. As a recap, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) or HR 6, was a bipartisan bill passed in October of 2018. It
FDA Looks to Pilot Projects to Enhance Pharma Track and Trace
The U.S. Food and Drug Administration (FDA) is taking a critical step to further enhance its nascent electronic track and trace system for prescription drugs, which was established as part of the Drug Supply Chain Security Act (DSCSA) of 2013. The DSCSA authorized the FDA to build an electronic, interoperable track and trace system by 2023 to reduce drug diversion and introduction of counterfeit products into the U.S. drug supply chain.[1] As part of the Act, FDA was required
Opioid Package Signed into Law To Help Stem Dramatic Rise in Fatal Fentanyl-Related Overdoses
Fentanyl has made the opioid crisis ever more deadly. The sharp increase in fatal overdoses from fentanyl and fentanyl analogs (e.g., synthetic opioids) accounted for nearly 30,000 overdose deaths alone out of the estimated 72,000 Americans who died from drug overdoses in 2017. Even more concerning, the DEA has seen a sharp increase in fatal overdoses due to fentanyl-laced counterfeit opioids and non-opiate prescription medications. Counterfeit prescription pills containing
New Initiative on Illicit Fentanyl's Danger
The Partnership for Safe Medicine 2018 Interchange held in Washington D.C. on June 7th brought together policymakers, counterfeit drug victims, pharmaceutical manufacturers, patient advocates, law enforcement, and healthcare professionals to discuss solutions to the deadly impacts that counterfeit drugs are having upon U.S. Citizens. Venture Global's Managing Partner, Sven Bergmann, conducted a panel discussion on Introducing the Fentanyl Council. This is PSM's joint project
