US generic drug manufacturer pleads guilty to felony
Carolina and Alabama, has pleaded guilty to 19 felony counts of
producing adulterated drugs and introducing them into interstate
commerce.
Vintage admitted that from January to October 2000 it brought to market approximately 50m tablets of thyroid drug Levothyroxine Sodium, USP, aware that its methods of assigning expiration dates did not conform with the good manufacturing practice (GMP) required by the US Food and Drug Administration (FDA).
The Huntsville Times reported that the company, according to prosecutors, used a 12-month shelf life date stamp on 19 batches of the drug, despite the fact that the batches risked falling below the FDA-required potency limits before the expiration date was placed on the label.
As a result, Vintage will pay $4.8m (€3.8m) in fines and forfeit $1.2m in proceeds from criminal activity. It stopped making the drug in 2001, following in a settlement with the FDA.
As part of a plea agreement, the company's founder and CEO, William Propst Sr, will give up his position with Vintage Pharmaceuticals, but continue to serve as chairman of Qualitest Pharmaceuticals, the company's marketing and distribution arm.
He was given a $19,000 fine and cannot seek employment with any company making pharmaceutical products during a five-year probation period.
His son, William Propst Jr., who had served as Vintage's president, pleaded guilty to one misdemeanor count, was given a $1,000 fine and is barred from working in drug manufacturing for three years.
He will now give up his role at Vintage and serve as vice chairman of Qualitest.
Vintage and Qualitest employ 620 people, including 500 in Huntsville and 120 in Charlotte.
Tom Young, CEO of Qualitest and Vintage and their subsidiaries, will continue to direct the company's operations and serve as interim chairman of the Vintage boards.
