The former chief executive officer of a generic drug maker will serve 30 days in jail for allowing his company to sell oversized pills, which exposed consumers to a risk of serious and potentially life-threatening injuries from a drug overdose.
Marc Hermelin, former CEO of KV Pharmaceutical Co., pled guilty to two misdemeanor violations of the Food, Drug and Cosmetic Act earlier this week. He has been sentenced to serve 30 days in jail, pay $1 million in fines and forfeit $900,000 in earnings.
Hermelin was charged with overseeing the sale of poorly manufactured and oversized morphine sulfate tablets, as well as other drugs, in 2007 and 2008. The sentence follows a long list of recalls and violations by both KV Pharmaceutical and its subsidiary, Ethex.
Production by the company in the United States was put on hold in 2009 after the FDA cited KV Pharmaceuticals for selling unadulterated and unapproved drugs, and in 2008, Ethex Corp suspended manufacturing and shipments for all products after issuing several generic drug recalls due to oversized tablets.
Among tablets that were distributed with too much of the active medication were generic versions of morphine, which could cause a potentially fatal morphine overdose. Also included in the recall were dextroamphetamine tablets that were generic versions of Dexedrine and Dextrostate. Ethex pled guilty to two felony charges by the U.S. Department of Justice (DOJ) and paid a fine of more than $23 million.
The Ethex morphine recall was first issued in June 2008, after it was discovered that manufacturing problems allowed oversized pills to potentially be distributed to customers. Subsequent recalls were issued for additional lots of morphine and at least 30 other generic drugs manufactured by Ethex which may have contained up to twice the necessary amount of the active pharmaceutical ingredient.
In November the FDA banned Hermelin from doing business with federal health care programs, leaving KV Pharmaceuticals no choice but to force Hermelin out if it wanted to continue to do business in the U.S.
The jail sentence comes amid increased pressure from critics of the FDA and pharmaceutical companies to levy real criminal consequences against drug company executives that break the law, as opposed to simply fining the companies large amounts of money.