The Justice Department announced today that:
SB Pharmco Puerto Rico Inc., a subsidiary of GlaxoSmithKline, PLC (GSK), has agreed to plead guilty to charges relating to the manufacture and distribution of certain adulterated drugs made at GSK's now-closed Cidra, Puerto Rico, manufacturing facility, the Justice Department announced today. The resolution includes a criminal fine and forfeiture totaling $150 million and a civil settlement under the False Claims Act and related state claims for $600 million.
The False Claims Act (31 U.S.C. § 3729–3733), on which see this, enables whistleblowers to sue in the name of the government and to receive damages when the suite proves successful. In the present case, a GlaxoSmithKline employee, Cheryl Eckard, asserted "…in her whistle-blower suit that she warned Glaxo of the problems [with the production of the affected medications] but the company fired her instead of addressing the issues," according to the New York Times report. The problem was the manufacture at a specific plant altered the nature of the drugs, as the Justice Department statement explains:
The Food, Drug and Cosmetic Act (FDCA) prohibits the introduction or delivery for introduction into interstate commerce of any drug that is adulterated. Under the FDCA, a drug is deemed adulterated if the methods used in, or the facilities or controls used for, its manufacturing, processing, packing or holding did not conform to or were not operated or administered in conformity with current good manufacturing practice to assure that such drug met the requirements as to safety and had the identity and strength, and met the quality and purity characteristics, which it purported or was represented to possess.
The drugs addressed by the suit: