05242017Headline:

Lansing, Michigan

HomeMichiganLansing

Email David Mittleman David Mittleman on LinkedIn David Mittleman on Facebook David Mittleman on Avvo
David Mittleman
David Mittleman
Attorney • (888) 227-4770

Generic Drugmaker Fabricates Drug Effectiveness Data to Get by FDA

Comments Off

Generic Drugmaker Fabricates Drug Effectiveness Data to Fool FDA

While the focus is usually on name brand pharmaceutical companiestaking prescription pill with milk, it’s actually the case that 80% of the prescription drugs in the U.S. are generic.  Those drugs largely originate from countries outside of the U.S., including India.  One of those companies, Ranbaxy, is under fire after a former employee blew the whistle on the generic drugmaker for fabricating drug effectiveness data to get the FDA to allow its products into the U.S.

Ranbaxy Executive Discovers Problem, Other Company Officials Do Nothing

Ranbaxy produces several important generic drugs, including generic Lipitor and drugs for HIV and other serious health problems.  In 2004, Ranbaxy executive, Dinesh Thakur, was asked to investigate allegations of fraud by the company.  That’s when Thakur uncovered problems with FDA required data that proves the effectiveness of drugs from Ranbaxy.  Thakur found that many of the company’s drugs had no data to back up their effectiveness, and he presented his findings to executives at the company in 2005.  He was thunderstruck when those executives did nothing about the problem.

Executive Blew Whistle After Son’s Illness Went Untouched by Ranbaxy Drugs

Thakur had never witnessed such callous behavior in his 11 years as a pharmaceutical representative.  And if that display of Ranbaxy’s behavior wasn’t enough to appall him, he was thrown into action when his young son was given a Ranbaxy antibiotic.  His son’s fever went untouched by the antibiotic, but was quickly reversed when Thakur decided to get his son another company’s formulation of the same drug.  That’s when he finally decided to blow the whistle on Ranbaxy and their apparently ineffective products.  After Thakur reported Ranbaxy to the FDA, the agency conducted an investigation and discovered that Ranbaxy had a persistent problem with submitting untrue statements.  The FDA ultimately concluded that Ranbaxy’s products were likely unsafe and not suitable for sale.  However, that’s not the end of the story; you can read more about how Ranxbaxy has continued to produce a large supply of generic Lipitor in the U.S. with the FDA’s approval.