Whistleblowers Serve an Important Purpose
Corruption is rampant. Despite the fact that the FDA is supposed to conduct independent and unbiased reviews, it often comes to light that this does not always happen. Many members of the FDA have either worked for large pharmaceutical companies or work for them when they leave. It is only natural, unfortunately, that bias occurs. Drug companies are wealthy companies and use this wealth to influence government through lobbying efforts, studies, grants and the like. Whistleblowers play an important role in managing corporate fraud. Our system is one of checks and balances. The recent case that settled for $7.3 million, United States ex rel. Smith v. Astellas Pharma, US Inc. et al., No. 10-999 (E.D. Pa.), where I was counsel of record and was the primary attorney representing Relator Smith for years, is an example of keeping a drug company in check. The drug at issue, Mycamine, was not a blockbuster drug by any stretch of the imagination; however, efforts to market the drug off-label were overlooked. While ultimately Astellas did receive a pediatric indication from the FDA, it took time and performance of the appropriate studies to make sure younger patients were safe and doctors adequately warned of the risks involved. Relators like Frank Smith should be commended for coming forward.
Claudine Q. Homolash, Esquire, founder of the CQH Firm, is a whistleblower, pharmaceutical injury and personal injury lawyer representing clients nationwide. She can be contacted at 1-(844) 677-4276 or (215) 496-1012 for a free legal consultation.