President Barack Obama’s newly anointed regulators at the Food and Drug Administration pledged early in 2009 to overhaul the embattled agency, which had come under fire for everything from food-contamination cases to its perceived coziness with industries. Wall Street Journal reporter Alicia Mundy’s investigative series on the FDA’s approval of a controversial knee-surgery device showed exactly why an overhaul was needed, revealing extraordinary conflicts of interest that led to a potentially unsafe device getting approval. Her reporting uncovered how strong-arming by the knee device’s manufacturer, its lobbyists and four members of Congress caused the agency to approve the knee-surgery product over the repeated objections of a half-dozen FDA scientists and managers.
