Bottle of Lies: The Inside Story of the Generic Drug Boom

Peter Baker is a drug investigator for the FDA, an organization tasked with ensuring the safety and efficacy of medications. Eban describes a visit Baker conducted on March 18, 2013. Over five days, he inspected a plant in India run by the generic drug company Wockhardt Ltd.

Eban describes how manufacturing irregularities and quality control issues at pharmaceutical plants can have serious implications for patient safety. At the same time, failed inspections can cost drug companies millions of dollars in lost revenue and can damage their reputation.

Wockhardt, like other overseas drug companies, has an advantage. While FDA investigators arrive at US-based plants unannounced and stay for however long is necessary, overseas plants are typically given advance notice of inspections, due to the complicated logistics involved with traveling and obtaining visas. Wockhardt knew ahead of time that Baker was coming, and he only had five days to inspect an enormous site.

Company officials prepared for the visit accordingly: They instructed employees to clean and organize the plant, remove any evidence of manufacturing irregularities, and present a facade of compliance. This approach usually worked. During a previous inspection, Wockhardt was given a passing grade, even though inspectors found evidence of manufacturing violations.