The War over Lipitor
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Business Article Reaction Paper #3
Course: MAT105 Introduction to College Mathematics
Name: Bridget E. Green
Instructor: Professor Robert Johnson
26 May 2011
Summary
The context of this paper summarizes an article titled “The War Over Lipitor” written by Katherine Eban for the Fortune 500 magazine. Ranbaxy, a pharmaceutical company in India, won the right to make a generic version of the $11 billion drug-only to be accused of serious fraud and shoddy practices in another case. Now there is a war over the mega popular cholesterol medication. The FDA accused Ranbaxy of a pattern of systemic fraudulent conduct over a period of years after a whistleblower at the company contacted the FDA. The investigation lasted four years and it turned up disturbing evidence. According to the federal agency, Ranbaxy fabricated data in drug applications, took shortcuts in crucial quality tests, and violated a raft of additional manufacturing standards. In 2008, the FDA barred Ranbaxy from importing 30 different drug products into the U.S. The ban remains in effect today. The federal prosecutors have been negotiating a criminal and civil settlement with the company that could lead to fines and payments exceeding $1 billion.
Deciding which company gets to make the first generic version of a drug is a complex process that combines private litigation and government regulation. The company must challenge the brand-name company in court and demonstrate that the various patents covering the original drug have run their course or are otherwise not valid. The applicant must also undergo a formal FDA review to see whether the proposed generic is the biological equivalent of the original and will achieve a similar level of concentration in the blood. The FDA has to also ascertain that the generics company is capable of manufacturing the medication in commercial quantities.
Reaction/Opinion
Ranbaxy should not be able to manufacture generic medication anymore. They...
Course: MAT105 Introduction to College Mathematics
Name: Bridget E. Green
Instructor: Professor Robert Johnson
26 May 2011
Summary
The context of this paper summarizes an article titled “The War Over Lipitor” written by Katherine Eban for the Fortune 500 magazine. Ranbaxy, a pharmaceutical company in India, won the right to make a generic version of the $11 billion drug-only to be accused of serious fraud and shoddy practices in another case. Now there is a war over the mega popular cholesterol medication. The FDA accused Ranbaxy of a pattern of systemic fraudulent conduct over a period of years after a whistleblower at the company contacted the FDA. The investigation lasted four years and it turned up disturbing evidence. According to the federal agency, Ranbaxy fabricated data in drug applications, took shortcuts in crucial quality tests, and violated a raft of additional manufacturing standards. In 2008, the FDA barred Ranbaxy from importing 30 different drug products into the U.S. The ban remains in effect today. The federal prosecutors have been negotiating a criminal and civil settlement with the company that could lead to fines and payments exceeding $1 billion.
Deciding which company gets to make the first generic version of a drug is a complex process that combines private litigation and government regulation. The company must challenge the brand-name company in court and demonstrate that the various patents covering the original drug have run their course or are otherwise not valid. The applicant must also undergo a formal FDA review to see whether the proposed generic is the biological equivalent of the original and will achieve a similar level of concentration in the blood. The FDA has to also ascertain that the generics company is capable of manufacturing the medication in commercial quantities.
Reaction/Opinion
Ranbaxy should not be able to manufacture generic medication anymore. They...