Casestudy of PharmaCare Company
Ethicaland legal rules and regulations are meant to guide a company intomaking the right decisions for the entire society even if it meansthe company has to take on losses. Some companies, however, breakthis regulation in pursuit of larger profits through unethical means.PharmaCare is an American based pharmaceutical company that isresponsible for the creation and sale of the AD23 drug. The drug hasbeen found to cause negative side effects and may even lead to death.This research looks into the ethical and legal codes the company hasbroken and the possible consequences of their actions. The researchwill also consider John, the former head of research in the team thatcreated the AD23 drug. The credibility of John`s case to claimownership of the drug is placed under investigation with a specificconsideration for patent and copyright laws. His role as awhistleblower to the company`s unacceptable behavior is also lookedat in this study. The inquiry will also explore and investigate therole of the Food and Drug Administration in regulation ofpharmaceutical companies with a specific interest in their role inPharmaCare`s case.
Thisresearch is aimed at scrutinizing PharmaCare and its involvement inthe drug AD23 which has caused death and side effects to somepatients the research is important as it will providerecommendations for a way forward and how to reduce occurrence ofsimilar cases.
Marketingand Advertisement Regulations
Dueto the nature of the business and their interaction with society inthe form of customers and other companies all businesses are taskedwith social responsibility, orderliness, and the code of ethics. Thepharmaceutical companies fall in a unique category since the effectsof their products could cause adverse effects to the health of anindividual. Ethical issues fall in the fields of marketing, productsafety, and intellectual property. The commercialization of the AD23drug by PharmaCare is in gross violation of the code of ethics alongwith other laws in the country. All companies are expected todisclose all relevant information about a product to the customermore so in the case of prescription drugs and other pharmaceuticals.While marketing the AD23 PharmaCare did not disclose the potentialside effects of the drug. Even after receiving information of thedeaths of customers caused by the consumption of the AD23 pill thecompany did not halt production of the drug instead they continuedmarketing and selling the product. The company had enough informationto warrant a halt on production but they decided to `roll the dice`(Carpenter, 2014).
Directto customer marketing
Directto customer marketing or advertising refers to the advertisement ofpharmaceutical products direct to the patients as opposed tomarketing towards the medical practitioners who then administer thedrug to the patient. Direct to customer marketing can be done overthe internet, on TV, print media social media and other mass media.In the USA direct to customer marketing is permitted and is regulatedby the Food and Drug Administration, FDA. Regulation is highlyrecommended in states allowing the practice due to the ease ofcustomer manipulation due to false advertisement by companies. Thesystem of direct to customer marketing is innovative and useful toconsumers but only if strictly regulated. However, companies areoften pulled towards false advertisement in the search for moreprofits at all costs (Collins,2013).
Inlight of this, the study recommends the abolishment of direct tocustomer marketing and advertisement. Companies managed by scrupulousmanagement will always look for loopholes in the regulations to takeadvantage of and use to manipulate customers. Consumers of the drugsalso have no way of knowing what the drug does and understanding indetail the effects of the drugs on the patient. Medicalpractitioners, on the other hand, can conduct tests on the drugs ifrequired. Another significant disadvantage of regulation is that acompany can only be banned or taken action against after negativelyaffecting consumers. This shows that regulation is not preventativebut curative. Disallowing direct to customer marketing will preventthe negative effects. The paper recommends that pharmaceuticalproducts should only be advertised to medical practitioners who thenrecommend to the patients.
Compensationfor Intellectual Property the USA
PharmaCare`snew drug AD23 is protected under the patent and trademarks law in theUSA since the company had patented the drug. John, the headresearcher on the development of the drug, does not have any legalclaim over the drug as he was part of a team that developed the drug.John was also an employee of PharmaCare when the drug was developed,and he worked under the structures of the company. This means Johncould not achieve the creation of the drug without company resourcesand help. John, therefore, could only claim common copyright but notsole ownership of the AD23 drug. The company should, however,compensate John for his participation in the creation of the drug.One of the ways the company can do this is by including his name in alist recognizing his involvement in the creation of the drug alongwith career advancements and promotions. Another way of compensatingJohn is by announcing him the co-founder of the drug and making himin charge of that specific drug. An alternative method ofcompensation would be allocating John and his research team a portionof the profits realized from the sale of the drug by PharmaCare. Johnalso suffered personally from the marketing and sale of the drug helost his wife due to consumption of AD23. The company is obligated tocompensate him for his loss as it is responsible for the effects ofthe drug (Shawaqfeh, 2014).
DeathFrom A Pharmaceutical Drug, Legal Claims And Litigation
Numerouscases of death by heart attack due to the use of the AD23 drug havebeen reported. John`s wife is among the patients who died as a resultof the drug. An alteration made to the AD23 drug meant to increasethe effects it is famous for went wrong and manifested negative sideeffects and even death. The responsibility for the deaths and sideeffects is divided among the parties involved in the creation of thedrug. John and his research team are partially responsible since theydid not carry out enough tests before distribution of the drug.PharmaCare is also partly responsible for not placing measures toprevent the distribution of harmful pharmaceutical products. Aftersometimes reports of deaths and side effects of the drug came in, butthe company proceeded with distribution making them responsible forthat action. The modified AD23 drug was also not approved by the FDAPharmaCare set up a subsidiary company to market and supply the drugso as to evade FDA suspicion. PharmaCare and all members involved inmarketing and sale of the drug could be charged legally, and thecompany litigated. The members involved would have to compensate theconsumers affected by the drug (Carpenter, 2014).
TheWhistleblower in Pharmaceuticals
Awhistleblower is a member or former member of an organization,government or institution that reports illegal practices within theinstitution. John having been an employee of PharmaCare with accessto information about the drug qualifies as a whistleblower. Johncould apply for security from the state as a whistleblower andpresent his case. John had access to information that showed the sideeffects of the drug which was released irrespective of the negativeimpacts it processed. John was not aware of the reported deaths atthe time of the release of the drug which vindicated him fromresponsibility. He also had access to an internal memo showing theintentions of the company to go ahead with the drug despite thefindings. He would then qualify to apply for protection and become awhistleblower against his former employer PharmaCare.
PharmaCareaccording to the research conducted has been involved in seriousviolation of ethical and legal rules. The firm has however madeexceptional sales and shown growth from the sale of the AD23 drug.The decision by the firm to continue sale of the drug was motivatedby the profits the company was making. PharmaCare and many otherorganizations place profits before the safety and health of itscustomers. The FDA should review laws regulating pharmaceuticalcompanies and legal action taken against PharmaCare. John should alsoact as a whistleblower in the matter as he had privileged informationand can prove useful in the investigation into the company.
Carpenter,D. (2014). Reputationand power: organizational image and pharmaceutical regulation at theFDA.Princeton University Press.
Collins,F. S., & Hamburg, M. A. (2013). First FDA authorization fornext-generation sequencer. NewEngland Journal of Medicine,369(25),2369-2371.
Shawaqfeh,M. S. (2014). Clinical Relevance of Pharmacogentic Testing: Clinicalvs. Ethical. JPharma Care Health Sys S1-e001. doi,10.