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