For decades, Merck misrepresented the efficacy of its mumps vaccine, marketing an “adulterated” drug without proven efficacy to millions of American children, according to a recently released expert report by Dr. David Kessler, former head of the U.S. Food and Drug Administration (FDA).
The report — posted in two documents and marked “highly confidential,” for “attorneys’ eyes only” — provides over 800 pages of Kessler’s opinion and analysis about the history and severity of Merck’s regulatory violations over decades, beginning in the late 1990s.
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