“The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak,” Dr. Woodcock said in 2017. “When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market.” She claimed the action would protect the public from further misuse and abuse, but the action was beyond belated: 11 years had passed since that drug’s approval, with an estimated 1.7 million Americans already suffering from substance use disorders related to prescription opioids.
In 2007, Purdue and three executives admitted to misleading regulators, doctors and patients about OxyContin’s risk of addiction, and agreed to pay $634.5 million in fines. Outside the federal courthouse in Virginia where they pleaded guilty to “misbranding,” Ed Bisch led relatives of the dead in a protest.
One of several parents who spoke at the court hearing, Mr. Bisch argued that the executives should face prison time. “The lies and deceits started at the top and caused to ruin countless lives,” he said. But to date, no one from Purdue has ever gone to prison for the role that OxyContin has played in the opioid crisis.
And the agency’s greenlighting of opioids continued. In 2013, the F.D.A. approved an opioid called Zohydro even though its own scientific advisers voted 11-2 against it. Critics were worried that the painkiller would be as easy to abuse as OxyContin initially was. But when they approved the drug, Dr. Woodcock and the F.D.A. did not demand the manufacturer at the time, Zogenix, add features that would have made it more difficult for users to crush the pill.
In 2015, the agency and Dr. Woodcock gave the nod to OxyContin for use in patients as young as 11 years old. In 2018, the F.D.A. approved Dsuvia, a fentanyl analogue that’s 1,000 times more potent than morphine. Even though one of the F.D.A.’s own advisory chairs predicted that the Dsuvia’s approval would lead to more abuse and death — nearly 47,000 Americans died of opioid-related overdoses in 2018 — this superpotent drug came to market anyway.
In the letter to Senator Hassan, Dr. Woodcock wrote that “our goal has been to ensure that our approval and other regulatory actions regarding opioids are science-based and that the agency’s benefit-risk framework considers not only the outcomes of prescription opioid analgesics when used as prescribed but also the public health effects of inappropriate use.”
But the pattern is clear. As drug overdoses fueled a decline in American life expectancy, drug makers kept bringing new opioids to market. Even when evidence suggested the risks outweighed the benefits, the F.D.A. was in the pocket of the pharmaceutical industry, which funds 75 percent of its opioid-approval budget via user fees. The agency has denied that this funding buys influence, and Dr. Woodcock has claimed that user fees accelerate innovation, but to many families, that drive for innovation resulted in a dereliction of duty, willful blindness and a generation lost.