Regulation, Compliance and Privacy

On 12 December 1995 the FDA approved OxyContin, an extended-release form of the opioid oxycodone made by Purdue Pharma, a private company owned by the families of Mortimer and Raymond Sackler. Its label said that the delayed absorption "is believed to reduce the abuse liability" of the drug, and Purdue's sales force used that language heavily. Its marketing told doctors that the risk of addiction was "less than one percent", drawing on a five-sentence 1980 letter to the New England Journal of Medicine about hospitalised patients that did not support any such claim for long-term outpatient use. OxyContin's US sales rose from about $48 million in its launch year to more than $1 billion by 2000 and peaked at roughly $3 billion a year around 2010–12 (reported). Purdue earned an estimated $35 billion from the drug.

The law caught up slowly and repeatedly. In 2007 a Purdue company pleaded guilty to felony misbranding and paid more than $600 million. Between 2008 and 2017, as lawsuits mounted, Purdue made about $10.7 billion of payments for the Sackler families' benefit, including taxes, about $4.1 billion of it in cash to family members (AlixPartners audit filed in the bankruptcy, reported). McKinsey advised Purdue from 2013 to 2017 on how to "turbocharge" OxyContin sales, and later paid about $573 million to states (2021) and about $650 million to resolve federal investigations (December 2024). Purdue filed for bankruptcy in September 2019 and pleaded guilty again in 2020, to three felonies, in a resolution of about $8.3 billion. In June 2024, in Harrington v. Purdue Pharma, the Supreme Court ruled 5–4 that bankruptcy law did not allow the Sacklers to be released from lawsuits without the consent of those suing them. A revised settlement of about $7.4 billion was confirmed in November 2025, and when the plan took effect on 1 May 2026 Purdue's operating assets passed to a foundation-owned successor, Knoa Pharma. Purdue is the clearest case in this book of a company whose product was approved and whose business was destroyed by what it said about the product, and how it was paid. This chapter maps the rules every healthcare company must satisfy.