Thursday, 14 January 2016

USFDA – Whistle blower Program

US FDA – Whistle blower Program

A whistle blower is a person who exposes any kind of information or activity that is deemed illegal, unethical, or not correct within an organization that is either private or public. Generally whistle blowers are courageous individuals who recognize a wrong practice and are willing to take risks in order to see that the wrongs are corrected.

In United States’ whistle-blower protection laws incentivise and protect people who expose unethical business practices. The whistle blower program has gained an element of popularity in pharmaceutical sector, because of the generous incentives offered by the US drug regulator which ranges between 10 percent and 30 percent of fines assessed. Ranbaxy Debacle is one of the classic example of US whistle-blower protection.

A whistle blower at Ranbaxy USA Inc., a subsidiary of India-based generic pharmaceutical company Ranbaxy Laboratories, received an award of $48.6 million for blowing the whistle on the company’s failure to comply with cGMPs. The drug company’s manufacturing facilities were found to have incomplete testing records, as well as an inadequate program to assess the stability characteristics of its drugs. Such testing is used to determine appropriate storage conditions and expiration dates for the drug, as well as to detect any impurities in the drug. The company failed to file timely “field alerts” with the FDA concerning these violations and agreed to settle the lawsuit for approximately $231 million.

It was Mr.Dinesh Thakur, who had served on the board of the drug firm between 2003 and 2005, approached the US Food and Drug Administration and department of justice with proof that the company had indulged in data tampering, supply of falsified data to the regulator and production and sale of substandard drugs.

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