French drug maker Roussel Uclaf SA will pay a $33 million fine after pleading guilty yesterday to misleading the U.S. Food and Drug Administration about where and how it produced an antibiotic at European factories.
The case marks the first time a foreign corporation has been criminally punished for defrauding the FDA about a pharmaceutical made outside the United States but marketed here.
It is among the highest fines ever imposed in a criminal pharmaceutical prosecution, according to federal prosecutors.
"If you plan on selling drugs to the American public, you play by our rules whether your company is located inside or outside the United States," Maryland U.S. Attorney Thomas M. DiBiagio said in a statement.
Under a plea agreement entered at U.S. District Court in Greenbelt, the company - now part of Aventis Pharma SA in Frankfurt, Germany - pleaded guilty to felony charges of conspiracy and defrauding the FDA.
There is no indication that the drug, Cefaclor, harmed anyone.