A small drug maker was fined $4 million for striking deals with two tiny companies to submit marketing applications for a pair of potassium chloride medicines on its behalf to the Food and Drug Administration — and did so in order to save $2.2 million in filing fees, according to the U.S. Department of Justice. And the penalty caps an unusual episode that had its roots in an earlier battle with another drug maker.
Lehigh Valley Technologies, which is now known as Genus Life Sciences, allegedly paid two small businesses to submit its new drug applications to the FDA because Lehigh executives knew the company was no longer eligible for a waiver to a small business filing its first application. Lehigh had won FDA approval for another drug, according to court documents.
About the Author Reprints
