Corporate Social Responsibility: What Went Wrong at Glaxosmithkline?
Corporate Social Responsibility: What Went Wrong at GlaxoSmithKline?
When London-based GlaxoSmithKline (GSK) paid a $750 million dollar settlement as part of a plea agreement that required it’s Cidra, Puerto Rico subsidiary SB Pharmco to plead guilty for knowingly selling contaminated medicine, it laid to rest any doubts that its business practices were in direct conflict with its commitment to both quality and to creating a strong ethical culture. There are, nevertheless, important issues that extend beyond the facts in evidence. This paper does not seek to re-litigate the government’s case against GlaxoSmithKline. It, instead, seeks to accomplish three basic goals: to offer insights into the failure of the Food and Drug Administration to carry out it’s post-approval mission which is to protect the public from unsafe drugs by enforcing best manufacturing practices; to explore the endemic failure of management at every layer to engage in ethical decision making; and finally to suggest measures that, if taken, might have prevented the mishandling of this matter by GlaxoSmithKline.
Not unlike the Minerals Management Service’s failure to provide the appropriate regulatory oversight of operators of the Deepwater Horizon offshore drill rig during the years leading up to the 2010 gulf oil spill, the U.S. Food and Drug Administration (FDA) failed in its statutory obligation to protect the public from unsafe drugs. Pursuant to FDA policy, as a part of the drug approval process, manufacturing facilities have to be inspected and found in compliance with regulatory guidelines and with what are called Current Good Manufacturing Practices (cGMPs). The FDA is authorized to delay drug approval pending remediation of defects, though it is not required by law to do so (Food and Drug Administration, 2010). In February 2002 the FDA established a new inspection regimen for the purpose of “evaluating through factory inspections, including
When London-based GlaxoSmithKline (GSK) paid a $750 million dollar settlement as part of a plea agreement that required it’s Cidra, Puerto Rico subsidiary SB Pharmco to plead guilty for knowingly selling contaminated medicine, it laid to rest any doubts that its business practices were in direct conflict with its commitment to both quality and to creating a strong ethical culture. There are, nevertheless, important issues that extend beyond the facts in evidence. This paper does not seek to re-litigate the government’s case against GlaxoSmithKline. It, instead, seeks to accomplish three basic goals: to offer insights into the failure of the Food and Drug Administration to carry out it’s post-approval mission which is to protect the public from unsafe drugs by enforcing best manufacturing practices; to explore the endemic failure of management at every layer to engage in ethical decision making; and finally to suggest measures that, if taken, might have prevented the mishandling of this matter by GlaxoSmithKline.
Not unlike the Minerals Management Service’s failure to provide the appropriate regulatory oversight of operators of the Deepwater Horizon offshore drill rig during the years leading up to the 2010 gulf oil spill, the U.S. Food and Drug Administration (FDA) failed in its statutory obligation to protect the public from unsafe drugs. Pursuant to FDA policy, as a part of the drug approval process, manufacturing facilities have to be inspected and found in compliance with regulatory guidelines and with what are called Current Good Manufacturing Practices (cGMPs). The FDA is authorized to delay drug approval pending remediation of defects, though it is not required by law to do so (Food and Drug Administration, 2010). In February 2002 the FDA established a new inspection regimen for the purpose of “evaluating through factory inspections, including
Cited: Barnard, C. I. (1983). The Functions of the Executive. Boston: Harvard University Press. Hosmer, L. T. (1987, August). The Institutionalization of Unethical Behavior. Journal of Business Ethics , 439-447. The New York Times Blog. (2010, October 27). Prescriptions, The Business of Health Care. Retrieved January 7, 2011, from New York Times Blog: http://prescriptions.blogs.nytimes.com/2010/10/27/glaxo-case-may-not-be-over/#more-30629 Williams, B Wilson, G. H. (2010, October 27). Glaxo to Pay $750 Million for Sale of Bad Products. New York Times , p. A1.