FDA Opioid Policy Needs Boost From Congress, Audit Says (1)

Congress could grant the FDA the authority to require that new opioid products show a benefit over painkillers already available, an independent review of the agency said.

The FDA has repeatedly faced scrutiny from lawmakers and others over the agency’s approval of Purdue Pharma LP’s OxyContin and other addictive drugs without requiring thorough warning labels and other protections that could help combat misuse. Drug overdose deaths have more than doubled in less than a decade to more than 100,000 per year, driven primarily by the fentanyl crisis.

The report published Thursday from a team of experts at The Ohio ...