The United States Justice Department charged Wyeth Pharmaceuticals $490.9 million for misbranding a drug. On July 30, the Justice Department informed that the company was regarded blameworthy to market an illegal drug that prevents the negative response of organ transplants. The report also revealed that Wyeth confessed the crime they have committed and granted to pay the fine imposed on them.
According to the reliable source, if Wyeth would pay the hefty amount, which was charged on them for marketing an unapproved drug, they would resolve from the charge of civil liability and criminal offense.
In order to get licensure for pursuing their business, each company required to follow the strict rule of United States Food and Drug Administration. It is noticed that the alleged company has broken this rule by marketing Rapamune, a prescription drug that is listed as unsafe in the regulation of FDA.
However, it is noteworthy that the company granted approval from the USA Food and Drug Administration to market Rapamune for the patients having kidney or rental transplant. This immunosuppressive medicine allows the immune system of the patient to accept the transplanted organs. Focusing on this issue, FDA has granted them permission to use the drugs.
However, Wyeth Pharmaceuticals has gradually started to endorse the drugs in all types of transplant operations. FDA even found that the company did not hesitate to offer financial incentives to encourage the use of Rapamune and wanted to prove the effectiveness of Rapamune for all types of transplanted organs.
FDA took strict steps against this business strategy of the company that was entirely directed to increase the sales of the drugs and not in the welfare of the patients. Western District of Oklahoma’s US attorney informed that the companies, which disregarded the agreement of FDA to satisfy their corporate strategy by ignoring safety, would face rigid penalties and criminal prosecution.
As being revealed in the report of the US government that Wyeth even did not follow the False Claims Act for a long period. Between 1998 and 2009, they promoted Papamune for unlawful purposes that resulted in the violation of False Claims Act of the government.
It is noteworthy in the context that Pfizer, which purchased Wyeth in October 2009, informed that the agreement was signed between the Department of Justice and Wyeth Pharmaceuticals. According to a reliable source, in an email to AFP the company stated that Pfizer would assist the government in every step of the investigation. They most strikingly added that the Pfizer was not the target or subject of the matter.
Wyeth also accused for promoting unapproved Protonix, an acid reflux drug from February 2000 to June 2001. However, in that time, Pfizer granted to pay the fine of $55 million to resolve the charge.