A prominent Washington food and drug lawyer has warned the pharmaceutical industry that three new civil money penalty provisions were added without fanfare to the Federal Food, Drug, and Cosmetic Act in last year's Food and Drug Administration Amendments Act (FDAAA). Writing in a Food and Drug Law Institute Update, John Fleder (Hyman, Phelps & McNamara) said the FDAAA authorizes the FDA to impose civil penalties on a person who disseminates or causes to be disseminated a false or misleading DTC ad. Violations are punishable by civil penalties of up to $10,000.
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