“The abuse and handling of reformulated Opana ER by injection resulted in a serious disease outbreak,” Dr. Woodcock said in 2017. “When we determined that the product had dangerous unintended consequences, we made the decision to request its withdrawal from the market. . She claimed the action would protect the public from further abuse and abuse, but the action was later: 11 years have passed since the drug was approved, with an estimated 1.7 million Americans suffering. already have substance use disorders related to prescription opioids.
In 2007, Purdue and three executives admitted to misleading regulators, doctors and patients about OxyContin’s addiction risk, and agreed to pay $ 634.5 million in fines. In front of the Virginia federal courthouse, where they pleaded guilty to “bad branding,” Ed Bisch led the relatives of the dead in a demonstration.
One of the many parents who spoke at the court hearing, Mr Bisch argued that the leaders should face jail time. “Lies and deceptions started at the top and ruined countless lives,” he said. But to date, no one from Purdue has ever gone to jail for the role OxyContin played in the opioid crisis.
And the agency’s green light on opioids continued. In 2013, the FDA approved an opioid called Zohydro even though its own science advisers voted 11-2. Critics feared the pain reliever was as easy to abuse as OxyContin initially was. But when they approved the drug, Dr Woodcock and the FDA did not ask the then manufacturer Zogenix to add features that would have made it harder for users to crush the pill.
In 2015, the agency and Dr Woodcock nodded to OxyContin for use in patients as young as 11 years old. In 2018, the FDA approved Dsuvia, a fentanyl analogue 1,000 times more potent than morphine. Even though one of the FDA’s advisory chairs predicted that approval of Dsuvia would lead to more abuse and deaths – nearly 47,000 Americans died of opioid-related overdoses in 2018 – this super potent drug still arrived. on the market.
In the letter to Senator Hassan, Dr Woodcock wrote that “our goal was to ensure that our approval and other regulatory actions regarding opioids are science-based and that the agency’s benefit-risk framework does not hold up. Only account for the results of prescription opioid pain relievers when used as prescribed but also the effects on public health of inappropriate use. “
But the pattern is clear. As drug overdoses fueled a decline in life expectancy in the United States, drugmakers continued to market new opioids. Even when the evidence suggested the risks outweighed the benefits, the FDA was in the pocket of the pharmaceutical industry, which funds 75% of its opioid approval budget through user fees. The agency denied that this funding buys influence, and Dr Woodcock claimed that user fees accelerate innovation, but for many families this drive for innovation has resulted in dereliction of duty, a willful blindness and a lost generation.