Generic Drug Safety (2019)

Since the 1980’s, almost all production of generic drugs has moved overseas, where FDA inspectors have a much tougher time making sure they’re following rules for safety. Slightly more than half of all Americans take prescription drugs, and 90 percent of those drugs are generic.

The FDA inspects health regulations and data in drug manufacturing companies to ensure the safety and quality of the environment and the actual drugs. Unfortunately, some companies worry less about the safety of the people using the drugs and more about speedy production and high profit margins.

Investigative journalist Katherine Eban uncovers the alarming level of fraud and deception that some generic drug companies have achieved in her new book, Bottle of Lies: The Inside Story of the Generic Drug Boom.

Eban conducted research for the book by following an FDA inspector through the process of exposing fraudulent practices at Indian and Chinese generic drug manufacturing plants. According to Eban, this investigator saw past the diversions, looking at the internal computer systems where he uncovered clear-cut data tampering. It turns out there was fraudulent quality data in 67 of the 86 plants the FDA inspector investigated in India and China over five years.

But it’s more than just data tampering. Basic health regulations like maintaining a sterile environment are often violated. Eban says there are cases where workspaces don’t even have bathrooms with running water, making it impossible for the employees to wash their hands.

Part of this problem is globalization. It’s harder for the FDA to investigate international plants. According to Eban, they’re often given notice a month or more in advance of an upcoming inspection, while companies in the United States have inspectors stop-in without any prior knowledge. Some Chinese companies will even pool resources to set up “show” plants, causing regulators to inspect manufacturers completely independent from the intended locations. In some countries, such as the United Kingdom and Italy, the FDA relies entirely on inspectors from those countries.

As it stands, patients are at the mercy of the companies producing the final product that’s handed to them at the drugstore. It’s nearly impossible to test every single pill as it comes into the U.S., and that’s why Eban says it’s so crucial that the common practice of fabricating fraudulent manufacturing data is curbed.

So what can be done? Right now, the onus is on consumers to research the companies producing our generics. Eban says the easiest way to do this is find the name of the manufacturer on your prescription label, then Google it along with the terms ‘FDA’ and ‘warning letter’. In some cases, that’s the most that can be done, at least until laws are changed. Further information can be found here.