Enforcement changes in new FDA law

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A prominent Washington food and drug lawyer has warned the 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.

Fleder says the penalty is up to $250,000 for the first violation in a three-year period. The penalty for each subsequent violation in that period can't exceed $500,000. There are provisions directing how the FDA calculates the number of violations and the factors to be considered when imposing a penalty.

The FDAAA provides the possibility of insulation from liability through submission of ads to the FDA at least 45 days before dissemination, giving the agency an opportunity to comment. The FDA cannot impose penalties if a company has submitted an ad for agency review, whether because the FDA required the submission or the company did it voluntarily, and has subsequently incorporated each FDA comment on the ad.

Fleder said the new provisions add teeth to some of the changes made by FDAAA: the expansion of clinical trials information required to be submitted to the government for a trial registry and results data bank; the FDA's authority to pre-review TV ads; and new provisions on risk evaluation and mitigation strategies and post-marketing studies.

Now defined as prohibited acts are: submitting false or misleading information to the registry and results data bank, failing to submit a required certification or filing a false certification with the FDA, and failing to submit required clinical trial information to the registry and results data bank.

Violations are punishable by civil penalties of up to $10,000.    

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