According to a recent article, the drug company Glaxo is now reportedly pleading guilty to three criminal counts related to a failure in reporting safety data and detailed information about a drug known as Avandia and introducing several misbranded drugs into the market.
The Food and Drug Administration has revealed in recent reports that the company decided to plead guilty after prosecutors revealed that the drug giant GlaxoSmithKline promoted Paxil as a drug designed to treat depression in children without the consent and full approval of the Food and Drug Administration. According to the case’s reports, the company also decided to promote Wellbutrin for weight loss, the treatment of addictions and attention deficit hyperactivity disorder regardless of the agency’s statement that claimed the drug was only approved to treat patients with depressive disorders.
News organizations covering this case have revealed that the company has agreed on paying fines to resolve the claims. The Justice Department has ordered Glaxo to pay at least $2 billion to resolve all claims that were filed under the False Claims Act on top of $1 billion that will be used to pay the plea agreement. A criminal fine of $956,814,400 is also included in the bill.
The company’s CEO has claimed they are terribly sorry this happens and that similar incidents are not going to happen again. The Food and Drug Administration revealed that it’s strictly prohibited for a drug company to promote drugs and varied substances that are not entirely approved by the federal agency.
The company has stated that its lawyers do not agree with most of the statements proffered by the Justice Department. According to the news, the company does not believe it committed any acts of wrong doing, unlike what has been stated by the Justice Department in court papers.
In a previous case involving another drug giant known as Pfizer, the company was ordered to pay $2.3 billion in civil and criminal fees after the drug maker was found guilty of improperly marketing at least 13 different types of drugs, including cholesterol fighter Lipitor.
The company GlaxoSmithKline has agreed that from now on, all of its products will be closely monitored by the government for the next five years to ensure the company is following up with the Justice Department’s ruling.
According to the news, at least another $3.5 billion will be used to cover all legal costs related to patients experiencing health problems related to the drugs improperly marketed by Glaxo. Patients’ lawsuits associated with the use of Avandia have reached the $700 million mark and according with the FDA, more cases are expected to be presented to the Justice in the future.