115 - Bottle of Lies, Generic Drugs Quality, Ranbaxy, Audits, and Inspiring Quality Pros with NYT Best-Selling Author, Katherine Eban
Katherine Eban, author of the New York Times bestseller 'Bottle of Lies', discusses her decade-long investigation into quality failures in the generic drug industry, focusing on the fraudulent practices of Indian manufacturer Ranbaxy. She details how Ranbaxy manipulated and fabricated data to secure regulatory approvals, creating a 'dual-track' system where lower-quality drugs were sent to less regulated markets while better-tested versions went to the US and Europe. Eban highlights the role of whistleblower Dinesh Takur and FDA inspector Peter Baker in uncovering these systemic issues, while also critiquing the FDA's reliance on pre-announced inspections and the ethical culture of pharmaceutical companies.