OxyContin New Drug Application

The OxyContin New Drug Application was the 1995 submission and review record that became a key document in disputes over what Purdue Pharma and the U.S. Food and Drug Administration knew about the drug’s risks. A copy given to Art Van Zee by his wife, Sue Ella Kobak, helped him explain the approval process to bereaved families and supplied a concrete basis for his questions about abuse, marketing, and regulatory oversight.

The document and its discovery

The application was filed in 1995, and its review was led by U.S. Food and Drug Administration examiner Curtis Wright. The dossier mattered to Van Zee not simply as a record of approval, but as a source in which warnings about the drug’s behavior could be read alongside the decisions that permitted it onto the market.

Kobak gave Van Zee a copy of the application as a Christmas present in 2000. He later described the document as exactly what he wanted that year. The gift became a durable part of his work on OxyContin: it allowed him to discuss the drug’s approval with people seeking to understand how a powerful medication had been authorized, and it informed his public challenges to the available evidence about abuse.

Risks recorded in the review

The application’s review described what could happen when an OxyContin tablet was crushed: the drug could be released immediately rather than in a controlled manner. It also recorded withdrawal symptoms in several patients during clinical trials. These details made the document important to Van Zee’s efforts to distinguish risks already documented in the regulatory record from claims that the company had only learned of abuse problems later.

Most strikingly, the review reported that 68 percent of the oxycodone in a single crushed tablet could be recovered when the material was liquefied and injected. The figure gave Van Zee a specific point of reference in conversations about the vulnerability of the product to manipulation. It later acquired still greater significance when he learned that the application’s study was apparently the only detailed study of potential abuse available to him.

A caution in tension with promotion

Curtis Wright’s approval summary urged caution in OxyContin’s marketing materials, advising that competitive promotion be limited. The book sets that caution against the subsequent promotion of the drug, noting that little care was taken to follow it. Wright went on to work as a consultant for Purdue Pharma two years after the review, a later connection that sharpened questions about the relationship between regulatory review and the company’s commercial interests.

The application thus stands in the account as both a technical record and a point of contradiction. Its review contained information about rapid release if tablets were crushed, withdrawal during trials, and the amount of drug recoverable from a crushed pill; at the same time, the marketing caution in Wright’s summary did not prevent aggressive promotion. The document’s importance lies in that contrast, not in any claim that the application alone resolved every question about the drug’s later effects.

Evidence carried into public disputes

Van Zee used the application to walk Barbara Van Rooyan through the FDA’s 1995 approval after her son, Patrick Van Rooyan, died in 2004, having taken OxyContin for the first and only time at a Fourth of July party. Her question about how such a powerful drug had reached the market gave the document an immediate human context: the approval record was not an abstraction to the families who were trying to understand a death.

In 2002, Van Zee also raised concerns at an FDA advisory hearing, where he described months spent looking for studies of the long-term abuse risks to patients using painkillers. Dr. Nathaniel Katz told him that such studies did not exist. Van Zee then recognized that the only detailed study of potential abuse he had found was Purdue Pharma’s 1995 study for the application—the same study that reported how much oxycodone could be extracted from a crushed tablet.

The dossier therefore recurred in two connected settings: as a document Van Zee used to answer a grieving mother’s question, and as the limited evidence behind his own challenge to experts and regulators. Its record of foreseeable risks, its marketing caution, and the later absence of further detailed studies made the application a focal point for examining what had been documented before OxyContin’s promotion and what remained insufficiently investigated afterward.