Bextra Essay

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Bextra Whistleblower Case Maria Benson Penny Garriott Latasha Randle Claire Toussaint LAW/531 May 21, 2012 Donna Ross Bextra Whistleblower Case A company that produces a product or service for consumer use understands there are agencies that regulate how the company conducts business. Every company should ensure that they are acting ethically and morally sound. Bextra is a medication produced by Pfizer that came under scrutiny after a whistleblower told about the company misusing the medication and providing kickbacks to those that pushed the use of this medication (Bextra Whistleblower Case Started Investigation of Pfizer, 2009). The regulating agency the Food and Drug Administration is involved with all medications and the company went against this agency. Here one can review a discussion on the company, the medication, regulatory agencies, whistleblower laws and strict liability regarding this case. The Federal Food, Drug, and Cosmetic Act (FDCA) gives the Federal Drug Administration (FDA), a regulatory agency, the power to “regulate the testing, manufacture, distribution, and sale of drugs” (Cheeseman, 2010, p. 695). The FDA gave Pfizer the approval to sell Bextra for certain purposes and only in certain doses. The whistleblower in the Bextra case, Kopchinski, alleges that Pfizer “promoted Bextra for uses and in doses that far exceeded what the FDA had approved” (Bextra whistleblower case started investigation of Pfizer, 2009, para. 4). The importance of an FDA drug approval is that it gives the consumer the confidence of knowing that the drug has been deemed safe for its marketed purpose. If the allegations against Pfizer are correct, Pfizer not only acted illegally, but it potentially placed its customers’ health at risk. The Whistleblower Statute, a part of the False Claims Act, allows an individual to file suit against a company for

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