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GlaxoSmithKline to Pay $750M for Adultered Drugs
BOSTON – GlaxoSmithKline’s subsidiary, SB Pharmco Puerto Rico Inc., will 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 company will pay a total of $750 million to resolve the criminal and civil liability.
According to the Justice Department, the company’s manufacturing operations failed to ensure that certain drugs were free of contamination from microorganisms. The company’s manufacturing process also caused certain tablets to split, and other batches to have the wrong mix of active ingredients. Additionally, the company suffered from longstanding problems of product mix-ups, which caused tablets of one drug type and strength to be commingled with tablets of another drug type and/or strength in the same bottle.
The adulterated drugs, manufactured between 2001 and 2005, include Kytril, a sterile anti-nausea medication; Bactroban, a topical anti-infection ointment; Paxil CR, a controlled release formulation of the anti-depressant drug Paxil; and Avandamet, a combination Type II diabetes drug.
The company has agreed to plead guilty to a criminal felony for releasing into interstate commerce adulterated Kytril, Bactroban, Paxil CR, and Avandamet, in violation of the Food, Drug and Cosmetic Act (FDCA). Under the plea agreement, the company will pay a criminal fine of $150 million, including forfeiting assets of $10 million. The guilty plea and sentence is not final until accepted by the U.S. District Court in Boston.
Under the civil settlement, GSK will pay an additional $600 million to the federal government and the states to resolve claims that it caused false claims to be submitted to government health care programs for certain quantities of adulterated drugs. The federal share of the civil settlement amount is $436,440,000, and GSK will pay up to $163,560,000 to states that participate in the agreement.
The company’s actions have been widely condemned, with many calling for greater regulation of the pharmaceutical industry. The FDA has also taken steps to increase oversight of the industry, including increased inspections and stricter guidelines for manufacturers.
The case serves as a reminder of the importance of ensuring the quality and safety of pharmaceuticals. The public has a right to expect that the drugs they take are safe and effective, and companies that fail to meet these standards will be held accountable.
Key Facts
- State: Federal
- Category: Crime
- Source: DOJ Press Release ↗
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