Excerpts from Bloomberg:
GlaxoSmithKline Plc agreed to pay $750 million to settle a U.S. government false-claims lawsuit over the sale of defective drugs.
The affected drugs included the antidepressant Paxil CR and the diabetes treatment Avandamet.
“We regret that we operated the Cidra facility in a manner that was inconsistent with current Good Manufacturing Practice requirements and with GSK’s commitment to manufacturing quality,” PD Villarreal, a Glaxo senior vice president, said in an e-mailed statement.
“The false claims arose out of chronic, serious deficiencies in the quality assurance function at the Cidra plant and the defendants’ ongoing serious violations of the laws and regulations designed to ensure the fitness of drug products for use,” the government said in court papers.
The U.S. Food and Drug Administration in 2005 seized some Paxil CR lots after it was discovered that the pills sometimes split inappropriately, according to court papers. Some of the pills lacked an active ingredient.
“We did not uncover any evidence that patients were harmed from these adulterated batches,” Ortiz said today. “It is critical we keep pressure on companies to follow FDA standards and play by the rules.”