For years, consumers around the globe have relied on generic drugs to provide inexpensive alternatives to ever-costlier brand-name pharmaceuticals. Underpinning that system is a promise: That generics are as effective and safe as the medicines they mimic. In 2019, Bloomberg News reporters around the world showed how that promise is being broken. Through deep investigative reporting and comprehensive news coverage, Bloomberg demonstrated that the global supply chain for cheap drugs has been inundated with dangerous toxins linked to cancer.
The revelations ignited a congressional inquiry and prompted the Food and Drug Administration to overhaul its safety oversight of drug manufacturers. The stories showed how over-matched and under-resourced regulators at the FDA have been unable to uncover, trace or stop the spread of these toxins. Even when aware of the problem, the agency has been slow to respond and in some cases resistant to warning the public.
Delving into the sources of these pills, Bloomberg reporters documented how suppliers in China, India and even the U.S. not only cut corners to keep costs down but hid test results that would’ve revealed the consequences of that cost-cutting.
Edney and her colleagues used inspection reports, government documents and human sources inside the FDA to document how the agency conducted fewer inspections in China as the country supplied more and more generics to American consumers. The findings helped prompt Congress to investigate the FDA’s policing of pharmaceutical manufacturers and to call for a Government Accountability Office report on the issue. The then-FDA commissioner also vowed to revamp the agency’s manufacturing rules to better protect the nation’s drug supply.
Bloomberg reporters didn’t stop there. In a Businessweek cover story in September, Edney and colleague Susan Berfield investigated the recall of the popular blood-pressure pill valsartan, showing how it became contaminated with the carcinogen NDMA due to failures at the drug’s Chinese manufacturer and the FDA. An agency inspector had discovered serious violations at the factory a year earlier, but his bosses overruled his recommendations/findings/etc.
A day after the story ran, U.S. and EU regulators announced they were investigating the same carcinogen – this time detected in branded and generic versions of Zantac, the popular heartburn drug. Edney broke news on the first two major drugmakers to halt global shipments of the drug based on those concerns. Edney and her colleagues’ work has been weeks and months ahead of similar reports from NBC News, the New York Times, and a book, “Bottle of Lies,” that all relied on many of the same human sources, government documents and anecdotes first revealed by Bloomberg.
Edney departed on maternity leave at the start of October, breaking news until her very last day in the office. Her colleagues have continued to report on the story, and in a capstone to the series, an investigation by Margaret Newkirk and Berfield demonstrated how the U.S. recall system – the last recourse to protect consumers from tainted medication – also is undermined by the FDA’s deferential and piecemeal approach to regulating the pharmaceutical industry. In the case of the valsartan recall, the system failed to inform many consumers that their drugs were dangerous.