Book Excerpt

In Bottle of Lies, investigative journalist Katherine Eban pulls back the curtain on the generic drug business

Bottle of Lies by Katherine Eban

A New York Times bestseller published in MAy, KAtherine ebAn’s expose shines new light on the mysterious generic drug manufacturing business. Almost 90 percent of America’s prescription drugs are generics, with the majority of them made overseas. Fraud is widespread, Eban writes, in order to circumvent inspections and maximize profits. FDA oversight has been, to be kind, uneven, she says. Over the past year alone, for example, there have been recalls of dozens of batches of blood pressure medication, including two last month. A number of problems—impure ingredients, infestations of birds and flies, faked sterility testing—can be traced to India, which manufactures 40 percent of generic drugs dispensed in the U.S. The following excerpt describes the successful FDA inspection pilot program that was instituted in India in 2014, and was inexplicably halted the following year, Eban says—leaving the health of American consumers at the mercy of unscrupulous companies.

In June 2013, the U.S. Food and Drug Administration tapped Altaf Lal, an American of Indian origin with sterling public-health credentials, to solve what appeared to be a diplomacy problem. The FDA’s relations with Indian regulators were in tatters, one month after India’s largest drug company, Ranbaxy, pleaded guilty to seven felonies related to falsifying quality data for generic drugs it was selling in the United States. Ranbaxy seemed to stand alone as an overseas drug company that had broken U.S. laws and flouted critical regulations.

Lal, the newly-appointed head of the FDA’s India office, outlined three goals in an agency blogpost: to establish a trusting relationship with

Indian regulators; to conduct “prompt and thorough inspections” at the

manufacturing plants that made drugs for the U.S. market; and to help Indian “industry and regulators understand that protecting the quality, safety and effectiveness of every product is essential.”

In India, the stakes could not be higher for American consumers. Forty percent of all generics dispensed to Americans are manufactured in India. Many of the manufacturing facilities are aseptic plants, which means they have to operate with perfect sterility, and they provide finished doses— completed capsules, pills, and tablets—to American patients. The U.S. and Indian governments needed to work together to ensure product safety: the United States was India’s biggest pharmaceutical customer, and India was one of its biggest suppliers.