The U.S. Public Health and the Dangers of Generic Drugs

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The following statement was issued by Dinesh Thakur, a public health advocate and policy expert focused on improving the quality of affordable medicines. A historic pharmaceutical industry whistleblower, Thakur’s story is chronicled in the new book, “Bottle of Lies: The Inside Story of the Generic Drug Boom,” written by award-winning journalist Katherine Eban.

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Public Health Advocate Dinesh Thakur

Fake quality-control data, fraudulent manufacturing records, unsanitary conditions like bird infestations, and cancer-causing and toxic impurities are just some of the serious problems found consistently by FDA’s own investigators during inspections at overseas generic drug manufacturing facilities.

“Today, generic drugs make up a staggering 90 percent of all retail prescriptions while 30 years ago they accounted for only 33 percent. The American public believes that once the U.S. Food and Drug Administration (FDA) approves a prescription drug, or over-the-counter medicine, it is of good quality and will provide the expected therapeutic benefits.

"What the public does not normally know, however, is that 80 percent of the ingredients for our generic prescriptions and over-the-counter medications are made overseas. The FDA’s own inspection data from the last five years raises critical questions about the quality and efficacy of these products that are made overseas for consumption by patients in the U.S. As a result, our affordable generic medicines can be of poor quality and even dangerous.

"In fact, fake quality-control data, fraudulent manufacturing records, unsanitary conditions like bird infestations, and cancer-causing and toxic impurities are just some of the serious problems found consistently by FDA’s own investigators during inspections at overseas generic drug manufacturing facilities.

"Unfortunately, the lack of consistent oversight – in line with what the agency provides for manufacturing facilities located in the U.S. – at these overseas facilities has become a key area of concern. The agency is constrained in part by the reality that, in some cases, the manufacturer cited for violations is the sole supplier of a specific drug to the U.S. market.

"Policymakers on Capitol Hill must address this real public health crisis in order to protect our nation’s drug supply. In addition, Congress and the FDA need to hold accountable the manufacturers who repeatedly put our public health in jeopardy without any serious consequences.”

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