The passage of the Hatch-Waxman Act in 1984, which created a regulatory track for generic drugs, marked the beginning of the generic-drug boom in the U.S. It was a response to rising drug costs and the outsized influence of the country’s pharmaceutical industry and provided bioequivalent drugs at a fraction of the cost to consumers.
Today, 90% of America’s drug supply is composed of generics and large-scale government health programs like the Affordable Care Act and Medicare Part D would be impossible without them. But as the manufacturing of generic drugs for the American market has moved overseas, primarily to India and China, the quality of many of these drugs has come into question.
The U.S. Food and Drug Administration (FDA), which is responsible for assuring the quality of brand name and generic drugs that might reach American patients, has proven ill-equipped to regulate overseas manufacturers of generics, according to Katherine Eban’s investigation into the dark side of the industry, Bottle of Lies: The Inside Story of the Generic Drug Boom (Ecco, May 2019).
Intense demand for cheaper medications and the “first-to-file” rule that grants six months of exclusivity to the initial manufacturer of a generic version of a drug led to the incentivization of speed over quality, according to Ms. Eban. FDA safety officers that she interviewed cited some plants in India – where 40% of the U.S.’ generic drugs are made – that used lower-quality, unapproved ingredients and manipulated data by secretly repeating tests in hidden laboratories and falsifying numbers, in turn endangering patient safety.
While FDA inspectors can show up at U.S. drug manufacturing plants at any time to ensure regulatory compliance, the inspection process is more complicated abroad. According to Ms. Eban’s research, FDA officials often notify global manufacturers months in advance of their visits in order to minimize diplomatic tensions. This gives noncompliant companies time to clean plants, destroy contaminated drugs, and shred or falsify documents before inspection.
Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, told NPR that the agency holds generic drug manufacturers to the same standards as brand name manufacturers. “Protecting patients is the highest priority of the FDA,” she said. However, the agency discontinued a short-lived pilot program in which it conduced unannounced overseas inspections in 2015, despite the rate of inspects resulting in serious findings increasing by nearly 60%.
“One response [to the drug pricing crisis] has been to push for more, cheaper generics made available as quickly as possible,” Ms. Eban wrote in a recent New York Times editorial, noting that the FDA approved more than 1,000 new generic drugs last year alone. “But that solution has come with a quality crisis that has been largely invisible to American consumers.”