Food and Drug Administration

The Food and Drug Administration (FDA) is the federal regulator whose opioid decisions in the book span drug approval, safety warnings, public petitions, and later product changes. Its significance lies in the tension between what regulators had been told about OxyContin’s risks and how slowly those risks were reflected in restrictions and public protection. The narrative does not treat the agency as the only force behind expanding opioid use: prescribing standards, commercial promotion, and other health institutions helped create the environment in which its decisions mattered.

Approval and the evidence on risk

In 1995, FDA examiner Curtis Wright reviewed Purdue Pharma’s application for OxyContin. The application included information that crushing a tablet could change its intended controlled release into immediate release, that withdrawal symptoms had occurred in several clinical-trial patients, and that 68 percent of the oxycodone in a crushed pill could be recovered when liquefied and injected. The book sets those details against Purdue’s later claim that it did not know the drug was being abused until February 2000. They make the approval record central to the question of when risks were visible to regulators and the manufacturer.

Wright’s approval summary urged care in the drug’s competitive promotion. The book contrasts this caution with the marketing that followed, and notes that Wright became a consultant to Purdue Pharma two years later. That subsequent employment does not by itself establish that his review was improper, but it sharpens the narrative’s concern with the relationship between regulatory judgment and the pharmaceutical industry. The application’s warnings and the eventual scale of promotion appear in close succession, leaving the reader to consider the distance between identifying a risk and effectively containing it.

Warnings, monitoring, and petitions

The FDA added a black-box warning to OxyContin in 2001. The warning marked a formal response to safety concerns, but it did not settle whether the drug’s use should also have been narrowed. In the account of Patrick Van Rooyan’s death and his mother Barbara Van Rooyan’s subsequent advocacy, the agency’s choice not to restrict OxyContin to severe pain is presented as a missed opportunity. Barbara did not oppose its use for terminal pain; she argued against prescribing it for chronic, noncancer pain before other treatments had been explored. Her criticism concerned both the original approval and later decisions that, in her view, failed to protect the public.

In January 2002, physician Art Van Zee drove to Maryland to testify at an FDA advisory committee meeting on the agency’s role in approving and overseeing narcotics. He appeared in his only suit and a Jerry Garcia tie given to him by his mother, facing Purdue executives and prominent pain-management experts, many of whom acknowledged having been paid speakers for Purdue. The forum ended with experts urging close monitoring for abuse and addiction once new drugs reached the market. Its recommendation pointed toward active surveillance, while the broader account asks whether such oversight arrived in time for people already exposed to the drug.

Barbara Van Rooyan pursued a recall petition and sought changes to OxyContin’s labeling. The petition was rejected, and a 2013 response from the Department of Health and Human Services declined the specific labeling changes she requested, while requiring other modifications to labeling for extended-release, long-acting opioid analgesics. The distinction matters: regulatory action continued, but it did not deliver the particular remedy she had sought. Her case makes petitioning a long process in which an agency can acknowledge safety concerns yet refuse the requested intervention.

Industry influence and the limits of oversight

The book places these decisions beside reporting published in 2013 about private meetings between FDA regulators and pharmaceutical executives. The meetings, held at least annually since 2002 through an industry-funded nonprofit, were associated with the development of “enriched enrollment”: a study practice that allowed companies to remove participants who did not respond well to a drug, potentially making trial results more favorable to approval. An FDA official rejected the suggestion that pay-for-play was part of the agency’s culture. The narrative presents the meetings and the official denial together, distinguishing evidence of recurring access and a consequential research practice from a proven claim that a particular FDA decision was bought.

Related scrutiny concerned pain advocacy organizations rather than the FDA alone. Reporting found that the American Pain Society and the American Academy of Pain Medicine promoted broader long-term opioid use while receiving millions from drug companies. That reporting prompted a Senate investigation into the organizations, the American Pain Foundation, Purdue, and other companies; its findings remained sealed in the Senate Finance Committee’s office. These episodes widen the question from individual agency decisions to the networks of funding, advice, research, and advocacy surrounding opioid regulation. They do not establish that every regulator or medical organization acted on behalf of a company, but they show why independence and transparency became central concerns.

The changing treatment landscape

OxyContin’s 1996 introduction coincided with the growing adoption of pain as the fifth vital sign. Hospitals and accreditation bodies were developing mandatory pain-assessment standards, and patient satisfaction surveys gave institutions incentives to treat pain more assertively. Those standards were not FDA policy: they belonged to a broader medical and accreditation system. Purdue planned to capitalize on that climate with branded pens, resource binders, and wall charts promoting the fifth-vital-sign concept, positioning itself as a source of materials for hospitals seeking to meet accreditation requirements. The episode helps explain why the FDA’s approval decisions operated within a much wider expansion of pain treatment and opioid promotion.

The book also contrasts the OxyContin history with a 2013 FDA decision on Zohydro ER. An expert panel had voted 11–2 against the new painkiller, yet the agency approved it; the public justification was that its benefits outweighed its risks. The episode does not make the two drug decisions identical, but it shows how contested judgments about opioid benefits and dangers continued after years of mounting concern. Separately, the CDC issued voluntary opioid-prescribing guidelines in 2016. That was not an FDA action, but it marks a later shift in the wider federal response: the question of safe prescribing was being addressed through guidance as well as through product approval, labeling, and market oversight. Across these episodes, the FDA appears neither as a regulator without authority nor as the sole architect of the crisis, but as an institution whose choices helped define what risks were communicated, what products remained available, and how much protection patients could expect.