A prominent Washington food and drug lawyer has warned theindustry that three new civil money penalty provisions were added withoutfanfare to the Federal Food, Drug, and Cosmetic Act in last year’s Food andDrug 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 imposecivil penalties on a person who disseminates or causes to be disseminated afalse or misleading DTC ad.
Fleder says the penalty is up to $250,000 for the firstviolation in a three-year period. The penalty for each subsequent violation inthat period can’t exceed $500,000. There are provisions directing how the FDAcalculates the number of violations and the factors to be considered whenimposing a penalty.
The FDAAA provides the possibility of insulation fromliability through submission of ads to the FDA at least 45 days beforedissemination, giving the agency an opportunity to comment. The FDA cannotimpose penalties if a company has submitted an ad for agency review, whetherbecause the FDA required the submission or the company did it voluntarily, andhas subsequently incorporated each FDA comment on the ad.
Fleder said the new provisions add teeth to some of thechanges made by FDAAA: the expansion of clinical trials information required tobe submitted to the government for a trial registry and results data bank; theFDA’s authority to pre-review TV ads; and new provisions on risk evaluation andmitigation strategies and post-marketing studies.
Now defined as prohibited acts are: submitting false ormisleading information to the registry and results data bank, failing to submita required certification or filing a false certification with the FDA, andfailing to submit required clinical trial information to the registry andresults data bank.
Violations are punishable by civil penalties of up to$10,000.
From the April 01, 2008 Issue of MM+M - Medical Marketing and Media
