PharmaCARE is one of the leading pharmaceutical companies in the world, which has made a significant contribution to the development of drugs and treatment of diseases. The health care system, insurance companies, private healthcare centers, and regulatory bodies such as the Food and Drug Administration view PharmaCARE as a noble pharmaceutical company that sets professional standards in research and healthcare sectors.
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Owing to its matchless stature and trust that PharmaCARE has enjoyed for decades, regulatory bodies weakened their scrutiny and thus provided a leeway for the company to abuse its privileges, practice unethical activities, and violate regulations.
Some of the notable activities that constitute unethical practices and violations are exploitation of the Colberian indigenous population, destruction of endangered species, establishment of CompCARE, formulation of AD23, and mistreatment of employees amongst other unprofessional practices. Therefore, this essay analyzes CompCARE in terms of its stakeholders and practices in relation to ethics, standards, and regulations that govern pharmaceutical companies.
The stakeholders of the scenario of PharmaCARE range from organizations to individuals. PharmaCARE is the main stakeholder in the scenario because it bears the responsibility for all activities that take place in the scenario. Since the chief executive officer of the PharmaCARE serves on the PhRMA board, the PhRMA becomes an important stakeholder of PharmaCARE.
In the pharmaceutical industry, the Food and Drug Administration is a significant stakeholder because it ensures that the products that PharmaCARE generates and distributes to consumers have required safety and efficacy.
WellCo is a pharmaceutical company and a stakeholder in the scenario because it bought CompCARE from PharmaCARE and continued to sell AD23 to the patients with Alzheimer’s disorder. Given that employees experienced issues in CompCARE, the Equal Employment Opportunity Commission (EEOC) is a relevant stakeholder as it advocates for the rights of employees. The interaction and collaboration of these stakeholders led to the development of issues in the scenario.
The Colberian community is also an important stakeholder in the scenario because PharmaCARE exploited them and their natural resources. PharmaCARE exploited the Colberians because they paid them a dollar per day while making them to travel five miles on foot to and from the jungle to harvest medicinal plants and carry them. Moreover, PharmaCARE exploited the indigenous resources of the Colberian community, thus threatening the existence of endangered species of plants.
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Healthcare providers such as doctors, physicians, and clinicians are important stakeholders since they collaborated with PharmaCARE in prescribing AD23 as the medication of Alzheimer’s disease. Since patients consume pharmaceutical products of PharmaCARE, they are stakeholders of the scenario.
Specifically, patients with diabetes and Alzheimer’s disease are the stakeholders of the scenario because they utilize the same pharmaceutical compounds. Lastly, employees form important stakeholders for they represent pharmaceutical organizations that are in the scenario.
Firing of Employees
Allen could legally fire employees of CompCARE based on different reasons. Allen could fire Donna on grounds of poor performance due to chronic illness and absenteeism, which make her unable to perform her duties. Given that Donna has filled compensation, Allan should grant her and let he resign from the company. As Tom has already threatened to file a complaint with Occupation Safety and Health Administration, Allen should fire him for failing to maintain required safety and health standards by allowing mold to block air vents.
Regarding Ayesha, Allen should promote her to the position of supervisor and subsequently fire her because she has no supervisory skills that would enable her to become a supervisor.
According to Campbell (2011), “equal employment opportunity laws prohibit discrimination in most workplaces based on race, color, religion, sex, age, national origin, genetic information, and status as individual with disability or a protected veteran” (p. 22). In this view, the aforementioned reasons for terminating employees do not violate the laws of the EEOC.
To minimize risks that termination of employment could have on his department and company, Allen should fire his employees by following procedures that do not violate the laws of the EEOC. In the case of Dona, Allen should request her to perform a health checkup to establish if she still fit to work in the company. The recommendations of a doctor are important in the determination of her employment status.
In the case of Tom, Allen should assess his performance with a view of disproving his performance in the workplace because he failed to maintain safety and health conditions of ventilators in the laboratory. Concerning Ayesha, Allen should assess her suitability for the supervisory position and then fires her on grounds of incompetence. By following these steps, Allen could minimize risks that terminations pose on his department and the company, and thus promote effective resolution of employment issues in the company.
Whistleblowing Opportunities, Obligations, and Protections
Given that PharmaCARE established CompCARE with the main objective of reformulating diabetic medication into Alzheimer’s’ medication, it presents an opportunity for Allen to report the matter to the Food and Drug Administration (FDA). PharmaCARE has violated regulations and standards of the FDA that pharmaceutical companies should adhere in the process of drug discovery.
In the case study, it appears that PharmaCARE did not file a New Drug Application with the FDA and thus it reformulated diabetic medication into Alzheimer’s medication illegally.
According to Ahuja (2005), pharmaceutical companies should file a New Drug Application whenever they need to introduce a new pharmaceutical product into the market. In this view, Allen has an obligation to reveal illegal practices that PharmaCARE undertakes. Allen would benefit by receiving protection given that the federal government and the FDA have provisions that protect whistleblowers.
Allen also has an opportunity of whistleblowing since the director of operations in PharmaCARE is intimidating and coercing him to fire his juniors. The director gave ultimatum to Allen to fire Tom, Dona, and Ayesha or lose his job. The laws of the EEOC outlaw coercion and intimidation of employees against their rights and privileges (Campbell, 2011).
As the head of the CompCARE, Allen has the responsibility of reporting any form of violation that deprives employees of their rights in the workplace. Since the EEOC advocates for the rights of employees, Allen would receive protection, which would guarantee him his job in PharmaCARE. Thus, Allen should report illegal practices that lead to mistreatment of employees. Overall, Allen could benefit from whistleblowing because the EEOC would guarantee protect his rights as an employee.
The reformulated medication for Alzheimer’s disorder has adverse health effects that concerned bodies should note. The medication, AD23, is a new drug compound that PharmaCARE introduced into the market without undergoing the process of drug discovery including clinical trial and post clinical surveillance. Allen should report the adverse effects of the medication to the FDA and the Department of Health and Human Services (DHHS) and reveal how PharmaCARE manufactures it.
AD23 has adverse effects because researchers have linked it to over 200 cases of cardiovascular disorders that resulted in death of patients. Hence, Allen has an obligation to report the issue to the FDA and DHHS so that they can take appropriate intervention and rescue millions of patients who are taking the medication. The whistleblowing would benefit Allen because he would earn reputation and receive protection from the FDA and DHHS.
Purported Environmental Steward
The actions that PharmaCARE exhibits in the scenario depict it as a fake environmental steward. As a leading pharmaceutical company in the United States, PharmaCARE purports to advocate for the protection of the environment by promoting environmental measures such as using environmental friendly packaging, recycling of materials, and commencement of green initiatives.
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With its motto, ‘we care about your health,’ PharmaCARE projects its image as a pharmaceutical company that is cautious about the healthcare conditions of the population and their environment. However, PharmaCARE destroyed the Colberian habitat, endangered indigenous plants, and exploited the native community, which contrast its policy on environmental protection. Instead of protecting the Colberian habitat, PharmaCARE exploited it and made huge gains from the resources in the habitat.
Additionally, PharmaCARE overexploited the endangered indigenous plants without considering their sustainability and possibility of extinction. Since the community relied on the indigenous habitat, PharmaCARE exploited them and their resources without giving them due compensation. Therefore, PharmaCARE merely purports to support environmental protection, but in real sense, it practices the contrary.
Original Purposes of and the Changes to CERCLA
The Act, Comprehensive Environmental Response, Compensation, and Liability Act, protects the public and the environment from the release of hazardous substances. The original purpose of the Act is to ensure that the environment is free from any hazardous material while the population is free from any form of hazardous exposure. If there is a release of hazardous material into the environment, the CERCLA penalizes the parties involved to perform cleaning through the Environmental Protection Agency (EPA).
The changes made on the CERCLA include Superfund Amendments and enactment of the Reauthorization Act (SARA). The changes allow parties to undertake remedial initiatives with consent from federal courts and the public. This amendment allowed the responsible parties to undertake environmental pollution basing on the consent from courts and public approval.
Two provisions that are applicable in the scenario of PharmaCARE are remedial and removal action (Elfring & Gordon, 2003). In the aspect of remedial actions, PharmaCARE should conserve the habitat and help the indigenous population of Colberia. The second provision is that PharmaCARE should undertake removal action to eradicate harmful mold in the laboratory and remove its harmful products from the market. Hence, both remedial and removal actions would enable PharmaCARE to save humanity and environment.
Analysis of the scenario indicates that PharmaCARE went against regulations and provisions of the FDA, the EPA, the EEOC, and the PhRMA amongst other regulatory bodies in the United States. In the reformulation and sale of AD23, PharmaCARE did not adhere to the regulations of the FDA and the PhRMA.
In the aspect of conserving the environment, PharmaCARE violated the regulations of the EPA by exploiting natural resources without conserving them. Likewise, in the realm of employment, the management discriminated against employees thus violating the EEOC principles. Overall, PharmaCARE failed to adhere to the legal and ethical principles that govern pharmaceutical industries, and thus causing harm to patients, communities, and employees.
Ahuja, G. (2005). Drug Injury: Liability, Analysis, and Prevention. New York: Lawyers & Judges Publisher.
Campbell, C. (2011). Employee Rights Handbook: The Ultimate Guide to Fighting Back Against Firing, Harassment, Discrimination and More! New York: Minute Help Press.
Elfring, C., & Gordon, I. (2003). Superfund Strategy. New York: DIANE Publisher.