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Legal and Ethical Considerations in the Pharmacare Case

Essay by   •  November 7, 2016  •  Research Paper  •  2,440 Words (10 Pages)  •  888 Views

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Legal and Ethical Considerations in the PharmaCARE Case

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Question 1: Legal and Ethical Issues

Regarding marketing, the ethical issue is false advertising. The Federal Trade Commission Act stipulates requirements for honesty in marketing. Created by The Bureau of Consumer Protection, this regulation demands all advertisements not to be deceptive or unfair. It also requires marketers to display evidence to corroborate their claims. This law defines deceitful advertisements as those that are not only possible to mislead consumers who are sane but also affect their purchase decisions (Halbert & Ingulli, 2014). Moreover, the FTC delineates unfair ads as those that promote a product that cause unavoidable as well as extensive injuries that outweigh the verifiable benefits. In our case, PharmaCARE utilized unethical marketing methods. Its marketing was not straightforward because the corporation used corrupt physicians to promote its products thus misleading patients. Contrary to the FTC, the corporation also engaged in the marketing of harmful pharmaceuticals besides not exhibiting the deadly side effects associated with AD23.

        Regarding product safety, the ethical issue is dispensing harmful pharmaceuticals to patients. Ethical pharmaceutical corporations put the safety of their consumers first by making sure that their products are appropriate for use by human beings. In that sense, they are responsible to guarantee that the drugs do not compromise the well-being of individuals in any way. It is for this purpose that the federal government established the FDA, which developed regulations that demand pharmaceutical corporations to confirm product safety. In our case, the actions of PharmaCARE were unethical because the safety of its product was disregarded. The management discovered that AD23 was toxic because it led to fatalities as a result of heart attacks but chose to hide the evidence to continue marketing the product to unsuspecting patients. Moreover, the corporation engaged in an unethical practice by establishing another compounding corporation to evade all FDA federal regulations, which were created to safeguard the safety of drug users (Ferrell & Ferrell, 2012). PharmaCARE ought to have monitored the safety of AD23 starting from the design up to production. Epidemiological parameters besides pharmacovigilance were to be put in place. Quality control checks had to be conducted to certify that the quality of the drug was safe. Post-market surveillance, which is the final safety measure had to be performed after production to ensure the recall of all harmful products from the market. The corporation did not conduct security checks after compounding the drug because its researchers focused on curing Alzheimer’s disease without taking cardiac impacts into account. This unethical practice led to the fatalities of over 200 individuals. Additionally, the corporation did not terminate the production of the drug despite the evidence that it was deadly.

        Regarding intellectual property, there are no ethical issues. Intellectual property denotes to any invention that is the outcome of creativity to which one bears the rights to apply for a copyright. Copyrights are granted by the government to individuals or corporations to exclude copycats from creating patented discoveries for a set period. The types of patents acknowledged by law are plant patents, design patents, and utility patents (Bohlman & Dundas, 1999). Utility patents safeguard articles of manufacture, original processes, machines, or configuration of matter. Plant patents protect new selections of plants. Design patents guard the ornamental design of objects. The ethics in this field concern the fair usage of patented resources without any aim of profitmaking, stealing, or hidden exploitation. In our case, PharmaCARE performed its operation ethically with respect to intellectual property. The corporation utilized research from its researchers to develop AD23. The data, as well as technology utilized to create the product, was not stolen from any other corporation.

Question 2: Direct-to-Consumer Advertising

Direct-to-consumer advertising, which is often abbreviated as DTC advertising, mostly denotes the promotion of pharmaceutical products. This arrangement of advertising is focused toward patients instead of healthcare specialists. The Food and Drug Administration is in charge of governing DTC advertising inside the United States. Channels of DTC advertising include social media as well as mass media (print, television, radio). Direct-to-consumer advertising should be prohibited because to a great extent the advertisements often improperly influence the recommending of prescription medicines based on patients’ demands, which in many cases are not medically required (Christensen, 1995).

The fact is that direct-to-consumer advertising is employed to drive choice instead of informing it. The marketing is usually in the direction of costly brand-name drugs. Consumers often go to their physicians to pressure them into to prescribing them the drugs after watching these pharmaceutical advertisements. As a result, patients frequently get their prescriptions whenever they demand for these specific medications by name (Christensen, 1995). In an age of joint decision-making, there is a higher likelihood that general practitioners could do what their patients demand. Beyond these scenarios, physicians can also be enticed by large pharmaceutical corporations to prescribe their medicines. Besides, direct-to-consumer advertising can be blamed for encouraging the off-label use of prescription drugs, which is not permitted by the FDA. One case of this is the usage of certain pharmaceuticals as substitutes for surgery.

Furthermore, there are concerns that the rising proliferation of direct-to-consumer advertisements are driving the demand for expensive brand-name drugs despite the availability of less costly alternatives that are also effective. The net outcome is higher charges for the taxpayers as well as consumers. It is the matter of prices that has placed the issue of pharmaceutical marketing as well as use firmly at the center of the present review of the American health care structure (Christensen, 1995). Many consumers in the U.S. have recognized that this form of advertising is amongst the reasons why they bear drug expenditure bills that are totally out of control. Large pharmaceutical corporations often argue that direct-to-consumer advertising is beneficial to the whole healthcare structure in the U.S. because it encourages patients to search for remedial attention that could help them control their conditions as well as avoid unwanted surgeries hospital or stays. However, that is not factual.

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