Bottle of Lies | Katherine Eban

Summary of: Bottle of Lies: The Inside Story of the Generic Drug Boom
By: Katherine Eban

Introduction

Prepare to uncover the unsettling truths behind the generic drug manufacturing industry in the New York Times bestseller, Bottle of Lies by Katherine Eban. This riveting work exposes an industry plagued with corruption and fraud, using the shocking case of Ranbaxy Laboratories as its illustrative centerpiece. Delve into the treacherous world of regulatory bodies such as the US Food and Drug Administration (FDA) and learn how insufficient oversight has jeopardized the safety and efficacy of drugs produced overseas. As you navigate through this chilling exposé, consider the enormous cost of compromising drug production integrity and the implications for public health.

Corruption in the Generic Drug Industry

In “Bottle of Lies,” Katherine Eban exposes the corruption and fraud rampant in the generic drug industry through the lens of the
Ranbaxy Laboratories case. Eban demonstrates that regulatory bodies like the US Food and Drug Administration have failed to stop
malpractice. Despite the disturbing revelations, Eban’s investigative journalism has earned the book critical acclaim. NPR.org lauds it as
“propulsive, astounding, and disturbing,” and The Hindustan Times calls it “an extraordinary international corporate thriller.”
This necessary read sheds light on the dangers of the generic drug industry and its impact on public health.

The Generics Market

The generics market has become enormous, making up 90% of US drug inventory. When a brand-name drug’s patent expires, generic versions are formulated, helping to trim healthcare expenses. However, Katherine Eban’s book explores how this market’s size leads to fraud and corruption, with challenges in certifying drugs manufactured overseas. Without generics, healthcare programs such as the Affordable Care Act and Medicare Part D would be unaffordable, affecting patients and charitable organizations alike.

A Shortcut to the Market

In the 1980s, after heavy lobbying, policymakers created a process for FDA approval of generics that granted generic drug-makers a significant shortcut to the market. Instead of conducting long-term trials, generics companies only had to prove that their drugs were bioequivalent and performed similarly to name-brand drugs. While the FDA ensured compliance with good manufacturing practices, it could not carry out surprise inspections overseas, as noted by Eban.

Corruption in the Drug Industry

In “Bottle of Lies,” Katherine Eban reveals the corrupt practices within the US drug industry. Eban exposes how drug company executives bribed FDA reviewers and the lack of supervision on bulk drugs imported from overseas. The scandal led to the Generic Drug Enforcement Act of 1992 but the FDA still struggled to keep up with inspections by the end of the decade.

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