U.S. Food and Drug Administration

The U.S. Food and Drug Administration is the federal regulator at the center of several turning points in Dopesick’s account of prescription opioids: it approved OxyContin, was asked to restrict or withdraw it, and later approved another high-potency opioid despite substantial expert opposition. The book presents the agency not as a single decision-maker but as an institution whose initial reviews, postmarket oversight, and responses to public warnings had consequences that unfolded over years. Its record raises a persistent tension between authorizing medicines and policing their risks after they reach patients.

OxyContin Approval and the Record Before the Agency

In 1995, the U.S. Food and Drug Administration approved OxyContin following a review led by examiner Curtis Wright. When Art Van Zee later explained that approval to Barbara Van Rooyan, he had a copy of Purdue’s New Drug Application, which his wife, Sue Ella Kobak, had given him in 2000. The application’s contents, as described in the book, complicate Purdue Pharma’s later claim that it did not know of the drug’s abuse problems until February 2000.

The review documented several risks relevant to misuse. It described how crushing the tablets could change their intended controlled release into immediate release, recorded withdrawal symptoms in some clinical-trial patients, and stated that 68 percent of the oxycodone in one crushed tablet could be recovered when liquefied for injection. Wright’s approval summary also advised caution in the product’s marketing materials. The book sets those warnings against the scale of subsequent promotion, and notes that Wright began working as a consultant for Purdue Pharma two years after the approval. It reports the sequence and the documented connections without treating them, by themselves, as proof of what caused any individual regulatory decision.

Public Challenge and Industry Connections

In January 2002, Van Zee drove eight hours to Maryland to testify before a U.S. Food and Drug Administration advisory committee considering the agency’s role in approving and overseeing narcotics. He appeared in his only suit and a Jerry Garcia necktie, facing Purdue executives and prominent pain-management specialists. Many of the experts present acknowledged that they were, or had been, paid speakers for Purdue. The forum concluded with recommendations that the agency closely monitor abuse and addiction as new drugs entered the market.

The book places that public hearing beside a less visible set of institutional relationships. It reports that regulators and pharmaceutical executives held private meetings at expensive hotels at least annually from 2002, through a nonprofit funded by the drug industry. The practice of enriched enrollment that emerged from those meetings allowed companies to exclude study participants who did not respond well to a drug, potentially skewing trial results toward approval. The account does not identify those meetings as the sole explanation for any particular decision; rather, it shows how the development of evidence submitted for regulatory review could itself become a point of concern.

Industry ties also extended beyond those meetings. The American Pain Society and the American Academy of Pain Medicine promoted broader opioid use for long-term chronic pain while receiving millions of dollars from companies that manufactured opioids. A 2012 Senate investigation led by Chuck Grassley and Max Baucus targeted Purdue and several advocacy organizations and pharmaceutical companies. Its results remained sealed in the Senate Finance Committee’s office despite periodic calls for disclosure. Together, these episodes broaden the question from whether the agency received risk information to how public oversight operated in a landscape where drug companies and pain organizations had substantial influence.

Petitions, Delayed Decisions, and OxyContin’s Reformulation

Barbara Van Rooyan’s campaign brought the agency’s responsiveness into view at the level of a family’s loss. She supported OxyContin’s use for terminal or acute pain in circumstances where other, lesser opioids had not worked, but argued against its use for chronic, noncancer pain before other treatments had been explored. The FDA had earlier declined to restrict OxyContin to severe pain, a limit Van Rooyan believed might have reduced addiction without preventing access for terminally ill patients.

In 2010, Purdue introduced a reformulated version of OxyContin designed to make it harder to crush. Van Rooyan had petitioned for an opioid antagonist to be added to the drug; her account of the later pills was that attempts to crush them caused them to gel, making them difficult to snort or inject. As access to pills changed, former pill dealers began selling heroin instead. The book thus distinguishes a change in a medicine’s formulation from the disappearance of demand or the end of risk: restricting one route of misuse could alter the drug market without ending the broader crisis.

Two weeks before her son Patrick’s death, the U.S. Food and Drug Administration sent Van Rooyan a letter approving part of her petition: withdrawal of approval for the original OxyContin. By then, Purdue had already withdrawn that formulation voluntarily, three years after the reformulated product reached the market. Van Rooyan believed her petition may have helped prompt the change, but later came to suspect Purdue had acted because it was losing its patent on the original product, rather than because the new version was safer or because of her petition. The agency’s decision therefore arrived after the practical change had occurred and too late to alter Patrick’s outcome.

The same letter denied Van Rooyan’s request to limit the medicine to severe, acute, or terminal pain, and to reserve chronic use for cases in which other treatments had first been explored. Patrick had been dead for nine years. The book emphasizes that the petition addressed two distinct regulatory questions: the status of the original formulation and the circumstances in which OxyContin could be prescribed. The agency granted the first request only after it had become moot, while rejecting the second.

Later Decisions and the Watchdog Question

The agency’s later review of Zohydro ER brought the earlier OxyContin controversy back into focus. A month after Jesse Bolstridge died, the FDA approved this high-potency, long-acting hydrocodone product. Its expert panel had voted 11–2 against approval, warning that the drug lacked an abuse deterrent and could carry risks comparable to OxyContin in its original form. The FDA nonetheless concluded that the product’s benefits outweighed its risks. Critics cited the decision as an example of the difficulty of asking one agency both to approve drugs and then to function as their watchdog.

The contrast with subsequent action sharpened that criticism. Four more years passed before the FDA asked a pharmaceutical company to withdraw an opioid pain medication because of its abuse potential: Opana ER, in 2017. By then, annual drug-overdose deaths had risen to 64,000. The book presents the interval not as evidence that every opioid decision followed the same course, but as a measure of how slowly withdrawal action could follow the emergence of serious risks.

Across these episodes, the U.S. Food and Drug Administration’s importance lies in the sequence linking evidence, approval, public warning, and later intervention. The OxyContin application contained information about altered release and recoverable drug; Van Zee raised concerns before an advisory committee; Van Rooyan pursued a recall petition; and the FDA later confronted another disputed opioid approval. In the book’s account, regulatory responsibility did not end at market entry, and a decision made after years of delay could be formally significant while arriving too late to protect the people whose losses had prompted the appeal.