9 August 2019 - In the conclusion of her recently published book, “Bottle of Lies,” Katherine Eban briefly notes that the FDA avoids sanctioning generic manufacturers that sell drugs that are in short supply regardless of how poorly manufactured or counterfeit they are.
“Drug shortages had become a game,” she writes, “and the FDA was getting played.” Eban quotes an assessment by former FDA inspector Peter Baker: “There are no consequences for companies that are shipping substandard product. … It’s a win-lose situation and [patients] are the losers.”