Justice vs Drug Companies in the USA - Research Paper Example

Justice vs Drug Companies in the USA In recent years, the aggressive efforts of the pharmaceutical industry to direct market their drugs to health consumers has led to increased misrepresentation of product labels and advertising claims. In 2007, it is estimated that BigPharma budgeted amost $5B on the sales marketing of pharmaceutical products, all too often resulting in extravagant claims and a lack of emphasis on potential side effects of these highly touted pharmaceuticals (Frosch and Grande 2010, 1). Many experts believe that one of the most important reasons for misleading pharmaceutical labeling has to do with the tremendous growth of direct-to-consumer advertising (DTCA) over the past decade. These efforts can lead to excessive and inappropriate use of pharmaceuticals by health consumers. On the other hand, the pharmaceutical industry has claimed that this type of advertising has educated consumers on the different types of medications on the market and the diseases and disorders that can be treated medically. This rationale has contributed to an atmosphere of tolerance in regard to the often overstated claims made for pharmaceutical products. Research suggests that off-label prescribing of pharmaceutical drugs can result in exaggerated and untested claims by the drug manufacturer (Conko 2010, 2). Although the use of drugs for purposes other than their originally intended use can provide many medical benefits, it can develop into an accepted mode of expanding the use of pharmaceuticals beyond the appropriate scope of their health benefits; moreover, this practice may result in unwanted and unforeseen health effects. The FDA has a formal ban on off-label product promotion, but this is often sidestepped as anecdotal reports of health benefits associated with off-label drug use are promoted in labeling and promotional advertising. These practices have created considerable confusion among health consumers who are the primary targets of misleading product labels and inadequate instructions on the proper use of medications, their potential side effects and health risks (Gilhooley 2005, 2) Some legal commentators have cited the extravagant internet advertising of pharmaceuticals as an important expansion of promotional strategies that often neglect to clearly state the label properties and risks associated with the use of a specific drug (Plant 1998, 89). Section 502 of the Food and Drug Act deals specifically with issues of misbranding and false or misleading label practices by pharmaceutical companies (FDA 2010, 23). According to its provisions, a pharmaceutical drug label is considered at issue if any part of the label is misrepresented or misleading. This pertains to ingredients, quantity, source and packaging details. Any required labels must be prominently displayed and stated clearly. Any contraindications, risks, side effects or other precautionary warnings must be stated completely. If any health concerns have been documented associated with the correct use of the drug, this information must be provided on the label. In addition the common name of the drug must be displayed as prominently as the proprietary name. False claims of FDA approval or endorsement are also banned. In 2008, the FDA launched an assessment of pharmaceutical advertising of off-label drug uses in which the drug is advertised and labeled for use totreat a medical condition for which the drug has not received explicit FDA approval (Continho 2009, 279). Most recently, the Obama administration has begun to take a more aggressive approach to enforcing FDA guidelines as they affect both food and drug production, advertising and overall accountability (Zajac 2010). Another important issue relates to the liability of drug companies for harm resulting from the use of drugs that are mislabeled. The absence of warnings and appropriate advisories on drug labels can have serious health consequences. Legal experts have argued that the mislabeling of drugs puts patients at direct risk for which drug companies should be legally liable (Poser 2007, 653) There have been numerous legal challenges to the erroneous and misleading product labels and claims made by pharmaceutical companies attempting to entice new customers. Important legal proceedings such as the OIG Compliance Guidance for Pharmaceutical Manufacturers, the Sarbanes-Oxley Act, and the HIPAA guidelines have attempted to set limits on the appropriate marketing strategies for pharmaceutical products (Huberfeld 2007, 241). The goal of these legislative guidelines is to encourage pharmaceutical self-regulation in this important area; moreover, in the absence of such industry-motivated regulatory approaches, it will be far more likely that future legislation will impose severe restrictions on pharmaceutical practices in this area. Some legal analysts are critical of the current punitive environment surrounding legislative efforts to correct purported abuses of pharmaceutical labeling practices by the industry. Numerous legal actions have been brought forward based on the application of the Food, Drug and Cosmetic Act directives concerning the unlawful promotion of pharmaceuticals (Girard 2009, 120). In addition, the Department of Justice has increased the application of the False Claims Act to include the sales promotions to physicians to prescribe drugs based on untested, unsubstantiated claims. A good example of a case resulting from purported mislabeling involved liability of Purdue Pharmaceutical Corporation company executives for misleading labeling of the pharmaceutical oxycontin. In this case, it was alleged that the company executives had engaged in fraud by misleading the public based on false labeling. The disputed claims involved the label assertion that the product was not as addictive or as subject to symptoms of withdrawal as similar medications on the market, a claim that was shown to be medically false. Purdue ultimately had to admit corporate responsibility and pay $6m in damages (Gurney 2007, 5). It is essential that culpability in the legal sense reside with the leaders of pharmaceutical companies if this rampant mislabeling and misleading product representation is to be stopped. At the international level, based on the TRIPS Agreement, there is no international process for drug approval or marketing; therefore, individual countries have different rules about drug labeling and marketing procedures (Outterson 2004, 202). This has had the effect of creating much confusion internationally, particularly when US companies market their pharmaceuticals abroad. There is often a need to repackage and label the products under a completely different system of regulations. Given the global world market, many analysts believe that there should be internationally agreed upon standards for pharmaceutical labeling and marketing among member countries engaged in global pharma marketing. References Conko, Gregory. 2010. “Truth or Consequences: the Perils and Protection of Off-Label Drug and Medical Device Promotion.” Health Matrix:Journal of Law-Medicine 21:1-16. Coutinho, S. 2009. “License to Promote, or Just What the Doctor Ordered? The New FDA Guidance on Dissemination of Off-Label Reprints by Pharmaceutical Companies.” Temp. J. Sci. Tech. & Envtl. L. 28: 279-283 FDA Update. 2010. AAP News 31 ( 9S): 23. Frosch, D. and Grande, D. 2010. “Direct-to-Consumer Advertising of Prescription Drugs.” LDI Issue Brief. 15(3):1-4. Girard, Vicky. 2009. “Punishing Pharmaceutical Companies for Unlawful Promotion of Approved Drugs: Why the False Claims Act is the Wrong Rx.” Journal of Health Care Law and Policy 12:119-158. Greene, Stephanie. 2005. “False Claims Act Liability for Off-Label Promotion of Pharmaceutical Products.” Penn State Law Review 10: 41-68. Gurney, B., Shapiro, H. and Mays, R. 2007. “The Crime of Doing Nothing: Strict Liability for Corporate Officers under the FDCA.” Litigation Reporter 22(3):1-9. Huberfeld, N. 2007. “Pharma on the Hot Seat.” J. Health Law 40(2): 241-65. Outterson, K. 2004. “Pharmaceutical Arbitrage: Balancing Access and Innovation in International Prescription Drug Markets.”Yale J. Health Policy, Law & Ethics 1:198-278. Paradiso, A. 2009. “Prosecutorial Regulation of Off-Label Promotion: Sidestepping the Courts and Congress to Levy a Tax on Suspect ”Big Pharma” Marketing.” Syracuse Law Review 60: 161-4. Plant, Nancy. 1998. Prescription Drug Promotion on the Internet: Tool for the Inquisitive or Trap for the Unwary?” Saint Louis University Law Journal 42: 89-93. Poser, S. 2007. Unlabeled Drug Samples and the Learned Intermediary: The Case for Liability Without Preemption.” Food and Drug Law Journal 6: 653-657. Zajac, A. 2010. “Under Obama, a Reinvigorated FDA.” LA Times, October 9, Tribune Washington Bureau. Read More