Legal and Ethical Considerations in Marketing, Product Safety, and Intellectual Property Sam Cook

1. Research three to five (3-5) ethical issues relating to marketing and advertising, intellectual property, and regulation of product safety.

When looking at PharmaCARE’s relationship with the Colberians, you see that the company’s treatment of the indigenous population is unethical. In terms of intellectual property, the scenario in Assignment 2 highlights the exploitation of the Colberians. While the indigenous population freely shares their information about their cures, the company exploits them by not compensating them for their shared knowledge.According to labor laws, companies should work ethically and treat all of their employees fair not equal, but fair.

Some employees, based on their position and level of responsibility, should be paid more and should receive better perks than others. However, the company is earning millions of dollars from the knowledge being shared by the healers, and its executives live in luxury with swimming pools, tennis courts, and a golf course, while the Colberians continue to live in huts without electricity or running water.If the company compensated the healers for their intellectual property, the Colberians could improve their living conditions. PharmaCARE is taking advantage of this group of stakeholders because the healers are uneducated, ignorant to intellectual property laws, and do not know the true value of the information they are sharing with PharmaCARE. According to authors S.

C. Jain and R. Bird, the Trade-Related Aspect of Intellectual Property Rights (TRIPS) is considered the most relevant intellectual property treaty, and nations that have signed on must treat foreign intellectual property rights holders the same as domestic ones (2008, p. 7).Yet, PharmaCARE failed to compensate the healers of Africa in the manner required by U.

S. laws. Next, let us look at the relationship between the executives and the rank-and-file workers. Under CompCARE, demand and profits soared thanks to AD23, but when Allen informed the Director of Operations of concerns his employees brought to his attention, we see in Assignment 2 that he was told not only to fire the employees who complained, but to also keep his mouth shut about bogus prescriptions. In terms of employee relations, this is ethically wrong.

In Tom’s case, labor laws give him the right to inform Allen of poor air quality in the lab without the threat of losing his job. It is Allen’s responsibility to notify the executives, who in turn are responsible for correcting the problem. In Donna’s case, her illness and absences are caused by chronic bronchial problems associated with poor air quality in the lab, and labor laws give her the right to request worker’s compensation. In Ayesha’s case, although she is a long-serving employee who is said to be a very good worker, she has not been promoted to supervisor and feels she is being denied the promotion because she is a Muslim.She has the right to file an EEOC complaint without fear of retaliation because labor laws do not allow for any form of discrimination.

Not only will the EEOC investigation determine if she is being discriminated against, but it could also reveal the necessary actions or training needed by Ayesha to be promoted to the supervisory position. Before any employee is fired, a manager must clearly identify the reason why an employee should be fired and should review company policy on releasing employees to ensure compliance.Not only has Tom failed to do this, but he also failed to issue first and second warnings to the employees. Additionally, the fact that the Director of Operations ordered Tom to fire these workers and keep his mouth shut in order to maintain his employment is also against the law.

In a law suit, if an employer forces an employee to participate in breaking the law in order to maintain his job, courts will rule this as a violation of public policy, triggering the tort of wrongful discharge (Halbert, 2012, p 51).Finally, in terms of regulation of product safety, PharmaCARE threw all ethics out the window by working around a number of safety requirements and putting consumers’ lives at risk. The organization used its reputation as a caring, ethical and well-run company to pull the wool over the eyes of many. After reformulating a diabetes drug to treat those suffering from Alzheimer’s disease, PharmaCARE was required to seek FDA approval for distributing the new drug in mass quantities.Instead, it created a subsidiary that acted as a compounding pharmacy to distribute the drug directly to consumers on a prescription basis. Although pharmacy compounding, a practice where licensed pharmacists reformulate drugs to create a medication more suitable to treat a patient’s individual need, PharmaCARE, through CompCARE, went on to sell the product in bulk to hospitals, clinics, and doctor offices, an action not permitted by pharmacies.

Pharmacy compounding, when done properly, meets a vital public health need when a patient is unable to be treated with a medication approved by the U. S. Food and Drug Administration (FDA), but compounding was never intended to provide unapproved treatment to the masses. This is illegal and unethical.

One of the primary roles of the FDA is to regulate prescription drugs to ensure safety of the public, but motivated solely by profit, PharmaCARE took the compound route to avoid the lengthy and costly process of obtaining FDA approval. PharmaCARE then decided to operate business-as-usual after reports revealed that its reformulated drug caused heart attacks with users at disturbing rates.The organization fails to conduct its business with high morals, legal and ethical standards, and compromises safety in an unscrupulous manner. Just like PharmaCARE values profit over its employees, it values profit over safety.

2. Argue for or against Direct-to-Consumer (DTC) marketing by drug companies. Direct-to-Consumer (DTC) marketing of prescription drugs is banned in all countries except the United States and New Zealand. I have always been against DTC marketing by drug companies, and Assignment 2 only solidified my negative opinion of this practice.Although DTC has created a generation of consumers who appear to be more aware of the medications available to them, it has also created consumers who attempt to self-diagnose their medical conditions. With DTC, drug companies use advertisements to sell their products directly to desperate consumers by persuading patients to ask their doctors for expensive brand-name drugs sold by these companies.

I believe DTC marketing is biased, and I base this on the fact that the materials do not tell the whole story about the medication being advertised, but instead plays on the emotions of the consumer.Physicians attempt to promote healthy behaviors, screen for early stages of illnesses, and treat patients based on their individual needs, but DTC ads undermine those efforts, and like PharmaCARE, most drug companies are only concerned about profits. In addition to them encouraging consumers to ask for brand-name drugs, they are exploiting patients by convincing them to ask for drugs that may not meet their need. In all, both the drug companies and consumers are overlooking the fact that any type of medication can be fatal if administered incorrectly.Therefore, medications should only be prescribed to patients by a physician after a thorough evaluation and should not be prescribed based on a marketing and advertisement campaign.3.

Determine who regulates compounding pharmacies under the current regulatory scheme, what the Food and Drug Administration (FDA) could/should have done in this scenario, and whether the FDA should be granted more power over compounding pharmacies. Unlike prescription medications that fall under federal law and are subject to FDA approval, compounding pharmacies are licensed and regulated by state boards.Compounding pharmacies operate under the national guidelines established by the Pharmacy Compounding Accreditation Board, but accreditation is not mandatory and inspections are only performed every three years. The FDA cannot regulate compounding pharmacies because, when they operate under the national guidelines established for them, they do not manufacture new drugs.

In the 2002 Supreme Court decision of Thompson V. Western States Medical Center (535 U. S. 357, 2002), the ruling included a statute that exempted compounding pharmacies from FDA’s oversight for this reason (Thompson, 2009).In the case of PharmaCARE and CompCARE, the company did not reformulate a drug strictly to meet the individual needs of patients, but reformulated a drug and sold it to the masses without clinical trials that would have been required to obtain FDA approval.

CompCARE was created solely as a front for PharmaCARE, a manufacturer of drugs, and the bogus list of patients’ names provided to CompCARE by doctors was used to cover up PharmaCARE’s and CompCARE’s unethical practices.The FDA should have shut down CompCARE, and severely fined PharmaCARE for manufacturing a drug under the false pretense of compounding and halted the production of Alzheimer’s drug AD23. Since some compounding pharmacies are acting like drug manufacturers, FDA oversight is needed. Currently, these pharmacies are regulated by weak guidelines that were developed for pharmacies that reformulate custom prescriptions for individual patients, but now that they act like small drug companies by distributing large volumes of drugs to the masses, more FDA authority is needed.