Bottle of Lies: The Inside Story of the Generic Drug Boom
By Katherine Eban
Ecco, 2019, 512 pp.
In this sometimes frightening book, Eban delves into the dangerous market of generic pharmaceutical drugs. In the United States, the Food and Drug Administration must certify the patents for new drugs, a vetting process that began in the early twentieth century to guard against fake medicines. When these patents expire, firms can make generic versions of the same drugs by reverse engineering their active ingredients to produce equivalent medicines without incurring the costs of research, development, and testing. Generic medicines are therefore much more affordable for patients around the world. Eban tells the story of Ranbaxy Laboratories, a now defunct Indian generic drug firm, and its successful but problematic entry into the U.S. market and into other less regulated markets in other countries. She examines the FDA’s spotty procedures for inspecting manufacturing plants outside the United States and the Department of Justice’s fumbling in prosecuting Ranbaxy and its leaders for criminal behavior such as faking compliance with FDA rules. Such illicit activity turns out to be widespread in foreign generic drug firms, especially those in China and India. These firms are skilled at fooling the FDA and other regulatory agencies. Eban’s detailed investigation reveals that government bureaucracies in the United States and abroad are ill equipped for the task of regulating the pharmaceutical industry overseas.