America’s Love Affair With Cheap Drugs Has a Hidden Cost
Data, documents and interviews show how a focus on cutting prices has come with risks to consumer health.
The day before Donald Trump was elected president, three federal inspectors arrived at Mylan NV’s manufacturing plant in Morgantown, West Virginia, and flashed their credentials. A tipster had raised concerns there might be unscrupulous activity at the factory where the generic giant makes some of its top-selling drugs. So, with Mylan executives looking over their shoulders in a conference room, the inspectors from the U.S. Food and Drug Administration, dressed in button-down shirts and ties, began an intense two-week examination.
The team of chemistry experts sifted through thousands of random files containing what appeared to be forbidden exploratory tests, which some drugmakers have used to prevent quality failures from coming to light. The inspectors suspected Mylan laboratory staff had recorded passing scores on drugs that originally fell short of U.S. quality standards.