The U.S. Food and Drug Administration’s approval of Zohydro ER, a high-potency, long-acting hydrocodone medication without an abuse-deterrent design, became a stark episode in the account of the opioid epidemic. The decision came a month after Jesse Bolstridge died in 2013, even though the agency’s own expert panel had voted 11–2 against approval. The book presents the decision not as the beginning of the crisis, but as evidence that controversy over opioid risks and the consequences of regulatory choices persisted while deaths were mounting.

Causes and Regulatory Context

The approval entered a crisis already shaped by more than any single medication or regulatory decision. The account links the epidemic’s growth to the collapse of work and rising disability, alongside the flood of painkillers promoted by pharmaceutical companies and approved by regulators. In rural counties, the decline of coal, globalization, and automation had accompanied rising unemployment, food insecurity, and disability claims. These conditions form part of the backdrop for the book’s argument: addiction and overdose cannot be separated from economic distress, while expanding access to powerful painkillers added another force to the crisis.

Jesse’s death belongs to a wider pattern. In 2013, he was one of 8,257 people in the United States who died in heroin-related incidents, a total 39 percent higher than the previous year. Roughly three-quarters of those who died had started on a path involving painkillers, often with a single prescription. The account places the Zohydro decision beside that pattern to underscore the stakes of approving another opioid medication while the risks of dependence and transition to heroin were already visible.

Approval Despite Expert Objections

The central dispute was unusually plain: the expert panel voted 11–2 against the product, noting that Zohydro ER lacked an abuse-deterrent design and could lead to addiction and abuse at a level comparable to OxyContin in its original form. The U.S. Food and Drug Administration nevertheless approved it, concluding that “the benefits of this product outweigh the risks.” The contrast between the panel’s warning and the agency’s decision makes the approval a case study in how regulatory judgment can diverge from expert advice.

The comparison to OxyContin also carried the weight of an earlier controversy. The concern was not merely that Zohydro was another opioid, but that it was a potent, long-acting product without a design intended to deter abuse, despite the experience of abuse associated with the original OxyContin formulation. Dr. Andrew Kolodny, a physician who advocated stronger restrictions on painkillers, described the approval as a repetition of the OxyContin story. His criticism focused on a regulatory structure in which the same agency both approves medications and is expected to monitor their risks afterward.

Regulatory Oversight and the Continuing Toll

The book emphasizes the gap between approval and later intervention. Four more years passed before the U.S. Food and Drug Administration asked a pharmaceutical company to withdraw an opioid pain medication because of its potential for abuse. That medication was Opana ER, and the request came in 2017. By then, annual deaths from drug overdose had climbed to 64,000. This chronology does not establish that Zohydro alone produced the later death toll; it shows how slowly the regulatory response to abuse concerns developed while the broader crisis intensified.

Kolodny’s wider criticism concerned the effect of Purdue’s marketing beyond the particular misbranding for which the company had faced consequences. He argued that Purdue had made the medical community more comfortable with opioids as a class, and that proper FDA oversight of opioids might have prevented the epidemic. The account presents this as his assessment, while connecting it to the agency’s later approval of Zohydro: a decision that renewed questions about whether warnings and evidence of risk could reliably constrain the supply of powerful pain medication.

Significance in the Narrative

Zohydro ER’s approval functions as a regulatory counterpoint to the personal stories of dependence and loss. Jesse’s death makes the timing especially sharp, but the episode is not framed as a direct explanation of his death: the approval followed it. Instead, the sequence places an individual loss alongside a national trend and a new agency decision, showing how the crisis continued beyond the lives already claimed by heroin.

The event also gives concrete form to the book’s broader account of responsibility. Economic collapse and disability helped create vulnerability; painkillers supplied an additional source of exposure; and regulatory institutions made judgments about which risks were acceptable. The panel’s 11–2 vote, the approval despite its objections, and the years before the agency sought an opioid withdrawal remain distinct parts of that history. Together, they make Zohydro ER’s approval a revealing moment in the ongoing dispute over how the risks of opioid medications were recognized, weighed, and acted upon.