26-04-2025
How the FDA Helped Ignite, and Then Worsened, the Opioid Crisis
An investigation into the agency's repeated violations of its own rules to approve addictive drugs—and its ongoing failure to rein in the public-health crisis.
By
On a sunny May afternoon 14 years ago, a group of doctors from across the country gathered in a windowless conference room at the US Food and Drug Administration's main campus in White Oak, Maryland, with an urgent message: Prescription opioids were not just addictive, they were also ineffective in treating chronic pain.
The physicians, all pain and addiction experts, told Janet Woodcock, then director of the FDA's Center for Drug Evaluation and Research (CDER), that pharmaceutical companies had lied when they claimed opioids harmed only abusers seeking to get high. The drugs could be valuable tools for relieving acute, short-term pain, the doctors allowed. But they accused the FDA of acting rashly, starting with the 1995 approval of Purdue Pharma 's OxyContin label, which helped expand opioid use to millions of new patients, including people with long-term conditions such as arthritis and back pain.
