Legal and Ethical Considerations

Assignment 3: Legal and Ethical Considerations in Marketing, Product Safety, and Intellectual Property LaKisha D. Perry-Green Dr. Charity Lanier, Professor LEG 500 Law, Ethics, and Corporate Governance December 12, 2013 Strayer University, RTP Campus

Legal and Ethical Considerations Abstract The relationship between legal and ethics has long been strained and confusing to understand. In todays business, ethics actually consist of a subset of major life values learned

since birth. Many in business use these life values to make decisions that have been passed down from family, educational and religious institutions. However, the message is not the same and each business person will apply their own unique interpretation. Nevertheless, everyone must have an ethical base that applies to conduct in the business world and in personal life.

Legal and Ethical Considerations Assignment 3: Legal and Ethical Considerations in Marketing, Product Safety, and Intellectual Property

Legal and Ethical considerations are a viable element in marketing, product safety and intellectual property, yet there continues to be the secret and unpredictable element that each organization cannot control, the employee. Ethical or unethical behavior is not entirely an issue of the character of the employee; it is determined by a lot of factors. Employees or people are influenced by the forces surrounding them their peers, their superiors, the reward system, group norms, and organizational policies and values. In this assignment, we will revisit the

organization PharmaCARE and how legal and ethical considerations affected their decision making in marketing, product safety, and the intellectual property of Colberia. Ethical issues There are many ethical issues relating to marketing and advertising, intellectual property, and regulation of product safety. We will look closely at a few and how these have a common component that must be included for an organization to have a strong ethical and legal relationship. Marketing and Advertising Every aspect of the marketing and advertising mix is subject to laws and restrictions. Every marketing manager will be confronted with how they must address ethics and law. Each marketing executive knows that rarely are there cut and dry answers to ethical issues that will arise during the normal course of business. (Lamb, McDaniel, & Hair, 2010). One ethical issue that will occur in marketing is how to be socially consensus. When a product is being marketed and advertised to a particular group, there must be ethical consideration of how this will affect the people you are targeting. Will this be considered stereotyping? Is this offensive to a particular

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group? Is it culturally sensitive? A marketer and/or advertiser must answer these and other ethical issues: What are the potential magnitudes of the consequences? What is the probability of a harmful outcome? What is the extent of the ethical problems within the organization? All are legitimate and expected questions that will arise from just the social responsibility in marketing and advertising. Intellectual property In intellectual property is necessary to give one the right to protect and own his work with the arrival of the digital age it has become much harder to remain in control of a persons intellectual property. This is because the intellectual property rights no longer protect exclusively the interest of preserving a trade secret but is now interested in preserving the monetary gain of a person. Regulation of product safety majorly involves the consumers act which aims at providing quality and healthy products to customers. (Borgerson & Schroeder, 2002) Regulation of product safety The ethical practice of any business to ensure that they give quality products while practicing social responsibility to the consumer. Product safety engineers are expected to determine the safety of products, obtain agency certifications for the products, and examine and test the products according to various standards. However, this is where ethics of the individual can be tested. As we learned in the CompCARE scenario, the safety engineers became aware of issues surrounding the product yet management ignored the risks for the high rewards and profits that PharmaCARE received. This continues to be an ethical issue with the regulation of product safety. It has been noted that if we stress higher standards for product safety, for example, not allowing the product to be manufactured in countries where we cannot regulate the conditions of

Legal and Ethical Considerations the facility. We continue to have sweatshops that produce many of the products we use on daily basis. Direct to Consumer Marketing Whenever we are watching our favorite prime time specials or shows or even sporting

event, it comes that awkward moment when a direct to consumer ad comes on for those suffering with erectile dysfunction. There is that moment that someone reaches for the remote before they read the line of what to do after 4 hours. Direct to consumer (DTC) ads are a nuisance and can take a great moment in your household from excited to anxious when the many side effects are mentioned by the announcer who makes them sound so very insignificant. As referenced on the FDAs webpage, these side effects lists are required for each of the ads. Provided by drug companies, these ads are aimed at a general audience, and not at health care professionals such as doctors, nurses, and pharmacists. The ads are broadcast on TV and radio, and published in magazines and newspapers normally is sections and times that are most popular or viewed. They also appear online, on the side of your Facebook page, even on your mobile devices such as while you are listening to Pandora. The most annoying part of the ads is that the DTC advertising often features celebrity spokespeople, computer generated characters, or actors portraying happy and satisfied patients. The FDA requires prescription drug makers to provide risk information in any promotion that qualifies as a product-claim advertisement. (Keeping Watch Over Direct-toConsumer Ads, 2013). The FDA and Compounding pharmacies Who regulates compounding pharmacies under the current regulatory scheme? The first element that we must address is what is compounding. Compounding is a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing

Legal and Ethical Considerations facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, or effectiveness of compounded drugs. Consumers and health professionals rely on the drug

approval process to ensure that drugs are safe and effective and made in accordance with Federal quality standards. (The Food and Drug Administration) What could / should the FDA have done in this scenario? As we learned in assignment twos scenario, PharmaCARE, in order to avoid FDA scrutiny, established a wholly-owned subsidiary, CompCARE, to operate as a compounding pharmacy to sell the new formulation of AD23 to individuals on a prescription basis. CompCARE set up shop in a suburban office park near its parents headquarters, and to conserve money and time, did a quick, low-cost renovation and designated Allen Jones to run the operations clean room. Compounded drugs lack an FDA finding of manufacturing quality before such drugs are marketed. State boards of pharmacy will continue to have primary responsibility for the day-today oversight of state-licensed pharmacies that compound drugs in accordance with the conditions of section 503A of the Federal Food, Drug and Cosmetic Act (FDCA), although FDA retains some authority over their operations. For example, the adulteration or misbranding of drugs compounded under section 503A, or false or misleading statements in the labeling or advertising of such drugs, may result in violations of Federal law. Firms that register with FDA as outsourcing facilities under section 503B will be regulated by FDA and inspected by FDA according to a risk-based schedule. (The Food and Drug Administration)This example provided by the FDA is how PharmaCARE was able to escape this scrutiny. Although technically the

Legal and Ethical Considerations organization should have been inspected by the FDA, they didnt denote the facility as outsourcing; they used an existing office park and did a renovation. Should the FDA be granted more power over compounding pharmacies? The FDA should be granted more power over compounding pharmacies. According the FDA website: . . . although FDA retains some authority over their operations . . . outsourcing facilities that register under section 503B are regulated by FDA and must comply with CGMP requirements and will be inspected by FDA according to a risk-based schedule.

As recent as last month, the FDA has been given more power as it concerns compounding pharmacies. On November 27, 2013, President Obama signed the Drug Quality and Security Act (DQSA), legislation that contains important provisions relating to the oversight of compounding of human drugs. Title I of this new law, the Compounding Quality Act, removes certain provisions from section 503A of the FDCA that were found to be unconstitutional by the U.S. Supreme Court in 2002. Section 503A describes the conditions under which certain compounded human drug products are entitled to exemptions from three sections of the FDCA requiring:

Compliance with current good manufacturing practices (CGMP) (section 501(a)(2)(B)); Labeling with adequate directions for use (section 502(f)(1)); and FDA approval prior to marketing (section 505). In addition, the new law creates a new section 503B in the FDCA. Under section 503B, a

compounder can become an outsourcing facility. An outsourcing facility will be able to qualify for exemptions from the FDA approval requirements and the requirement to label products with adequate directions for use, but not the exemption from CGMP requirements. Outsourcing facilities:

Must comply with CGMP requirements,

Will be inspected by FDA according to a risk-based schedule, and

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Must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound. According to the news release, if compounders register with the FDA as outsourcing

facilities, hospitals and other health care providers can provide their patients with drugs that were compounded in outsourcing facilities that are subject to CGMP requirements and federal oversight. If a compounder chooses not to register as an outsourcing facility and qualify for the exemptions under section 503B, the compounder could qualify for the exemptions under section 503A of the FDCA. Otherwise, it would be subject to all of the requirements in the FDCA applicable to conventional manufacturers. FDA anticipates that state boards of pharmacy will continue their oversight and regulation of the practice of pharmacy, including traditional pharmacy compounding. The Agency also intends to continue to cooperate with State authorities to address pharmacy compounding activities that may be violating of the FDCA. PharmaCAREs use of Colberian intellectual property Using the scenario from the previous assignment, PharmaCARE use of Colberias intellectual property without proper payment or acknowledgement is not in accordance with my own personal ethics or moral compass. It is not appropriate to deplete the resources of an area and not aid this area in rebuilding. The executives were living very well off destroying the natural environment of this African nation unfortunately the natives were not as fortunate. PharmaCARE use of Colberia intellectual property falls in line with ethical theory ethics of care. Ethics of Care is widely applied to a number of moral issues and ethical fields, including caring for animals and the environment, bioethics, and more recently public policy. Originally conceived as most appropriate to the private and intimate spheres of life, care ethics has

Legal and Ethical Considerations branched out as a political theory and social movement aimed at broader understanding of and public support for, care-giving activities in their breadth and variety.

Ethics of care is a theory which revolves around interdependence of every party involved. It bears the assumption that people and communities are different and vulnerability differs with different people. It also bears the consideration that their decisions affect different people with a different measure. Their practice supports these ethics of care as they know their services have high impacts on the lives of patients even though it may not be primarily positive as the scenario depicts. PharmaCAREs actions do not coincide with deontology because this ethical theory implies that we have a duty and that duty is based on rules. This ethical theory states that every human being possess those certain moral rights and duties and that ethical choices derive from universal principles based on those rights and duties. PharmaCARE is not using the utilitarianism approach as well. This approach to ethics states that ethically correct behavior is not related to any absolute ethical or moral value but to an evaluation of the consequences of a given action to those who will be affected by it. Applying the virtue of ethics theory to the PharmaCARE organization would not be appropriate as well. This theory states that our virtues are a matter of good habits, developed training and repetition with our individual communities. PharmaCARE and the United States Intellectual Property Laws Usually success in any global economy will depend more on the intellectual property of assets. Just like the other intellectual property based business PharmaCARE has driven a huge economic growth in the country of position as well as in the United States of America. The United States protection of intellectual property has been successful as a result of the advantages

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that come together with it. To start with, it is the worlds most recognized system of intellectual property regime since it has protected thousands of goods and assets (Laczniak, Bowie, & Klein, 2005). The procedures used are quite affordable and suitable for various businesses which need be acquired. In the United States, intellectual property laws cover a variety of services. For example, trademarks, which protect the companys brand and identities which can be acquired at a federal state level. There are also patents which are guaranteeing to protect a companys new inventions and the copyrights to protect creative expressions which are presented in recorded form. A significant factor that PharmaCARE has taken advantage of is the fact that intellectual property laws in the US the fact that the transparent and predictable legal systems which are applicable in the solving of disputes. Any company performing its business activities in the United States has the liberty of using the exceptional legal system which can help in the maximization of its intellectual property assets (Laczniak, Bowie, & Klein, 2005). The advancement in the legal systems has been able to promote the culture of respect after the transparency and predictability system. PharmaCARE have the privilege of having more enforcement options than anywhere else in the world. PharmaCARE and Colberia PharmaCARE has benefited financially from the nation of Colberia. These indigenous people sacrificed their land and lives to benefit PharmaCARE. The ridiculous bonuses its top executives have received from their profits do not seem to match the fact that most of the workers who are living in huts with no electricity or running water. How can PharmaCARE state that its actions are ethical when they are destroying the environment where these people will continue to live after they have benefited from its resources? There executives are living in estates where they

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have access to golf courses and swimming pools when its probable that many of the indigenous workers from Colberia have never seen a swimming pool. Most global corporations that are based in the United States yet have productions abroad try to pay their workers an hourly rate that is based on the current living wage for the area. It is a guestimate but more than likely the current living wage for a worker in Colberia is higher than a $1.00 a day. Surely, the executives could pay a $1.00 an hour to each worker that is traveling by foot into jungles with over 50 pounds of herbs more when at their highest point; the stock was valued at over $300 a share. The company could also commit monies to be left in trust to provide continued support to plant trees and rebuild in the country. PharmaCARE could also dedicate funds going forward to do charitable outreach programs with their employees traveling to this country and volunteer. PharmaCares scenario is real! Although the scenario given in assignment two was fictional, many pharmaceutical companies have faced similar situations like PharmaCARE. Similar to the CompCARE scenario where it was found that the AD23 drug was leading to heart attacks, Pfizer faced a similar situation with its drug Lipitor. Pfizer was in the forefront of the mass marketing of drugs, and of getting its sales force in front of doctors to persuade them to use Pfizer's products instead of a competitor's. And if its research labs weren't exactly prolific - Pfizer hasn't developed a blockbuster on its own since Viagra - it still managed to produce a steady stream of blockbusters by buying up other companies and acquiring their potential blockbusters. Pfizer was banking a great deal on a cholesterol drug it had developed called torcetrapib, the first drug aimed at raising the level of good cholesterol, rather than simply lowering cholesterol levels, the way Lipitor does. It would have been huge. But in early December 2006, the company announced that it had ended its efforts to develop the drug after a clinical trial showed a higher-than-expected number

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of deaths. The loss of torcetrapib was a crushing blow. Pfizer in 2007 lay off nearly ten percent of its staff because of declining sales. In 2007, they faced more than just a reduction in profits; they had diminished reputation which they really have never recovered. PharmaCARE and WellCo Lawsuits? In the short run, the shareholders of the PharmaCARE and WellCo had experienced an increase in dividends after the companys recorded profits. The stock price was recorded to be high and usually the higher the price of a companys stock in the market means that the returns are bound to increase. However in the long run they are expecting a slowed decrease in the returns and price of dividends. Whenever shareholders invest in a company they are expecting a high price on the payment of their shares than they bought the shares at the initial time. Shareholders success will also determine by the long run reputation of the companies which is portrayed through the quality of the products and services of the company. Further, the fact that the business is not concentrating on the improvement of the condition of its lab and the quality of its products it shows that they are not using many of its funds on such expenses. The significant aspect is that the business is ignoring its reputation so as to maintain high profits and please the shareholders. They would not be pleased if they knew the entire truth. In this scenario even though the business is enjoying large profits it will not continue for a long time. There has been an increased production which has led to increased cases of heart attacks. In a case of reduced prices of the shareholders dividends, the shareholders would sue the company for losses. Whenever the reduction in the price of shares and the stock has occurred for no apparent reason or a cause which is beyond the control of the company, the shareholders would have nothing to sue about. When CompCARE was sold to WellCo they were not aware of the product which had caused the massive deaths. Thus, for WellCo it would have little to

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answer to shareholders. The reduced stock price to both companies will reduce the shareholders returns. Their shareholders will most probably ask for a refund for the number of shares that they gave for the shares. This is due to the expected loss on its stock prices which might not be recovered. PharmaCAREs brand PharmaCARE clearly does not live up to its brand. At first it had a good reputation, consumer database and sales/marketing expertise. This made its products sales high and the company was able to enjoy more profits. It is later discovered that these products were dangerous causing many deaths as a result of heart attacks. The company however saw the reputation it initially had was an opportunity to get more profits and advertised its services to those who would buy just because of their brand name. The advertising was made to promote and create awareness of the particular drugs to consumers. They were not aware that these products were not quality for consumption but created in a way to ensure that consumers easily accessed the products from hospitals and clinics. Living up to its brand would require them to do an extensive research and inspection on its products to ensure that it is safe for the consumption of the human beings as well as having corporate social responsibility. Even though compounding pharmacies are not supposed to sell drugs large quantities for the general use, they were allowed to do so. CompCARE encouraged doctors to fax the list of the bogus patients. After the discovery that one of its products seemed to cause heart attacks, they ignored the complaints and still continued to file large orders instead of inspecting on the cause of the problem and to find ways to curb all that. When all else failed they sold the bad link and never looked back. Their brand name and reputation cannot be recovered by going to their local store and getting another one.

Legal and Ethical Considerations Conclusion

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In conclusion, legal and ethical considerations when it comes to marketing, advertising and product safety are essential elements to a company. As organization must balance the need to market a product with ethical and legal responsibility if they want to be successful overall. There are so many federal laws that affect marketing and product safety. It can fall into many categories of regulatory activity and we must be knowledgeable if we are to protect the consumer as well as the organization. PharmaCARE has not showed that there is an ethics and legal responsibility relationship. They have shown that they are not ethical with their environmental responsibility because they are not practicing the initiatives that they have stated to implement. They are not concerned with product integrity because they have known about the defective nature of their drug yet have not taken the appropriate steps to remove it from the marketplace thus saving the lives of the patients as well as their employees who produce it. PharmaCARE is not concerned with its legal responsibility since it was able to skirt its the regulations of the FDA by using compounding pharmacies. With the new legislation that was just passed last month, real world PharmaCARE as well as others will not be able to make this scenario come to pass or they will face stiff penalties.

Legal and Ethical Considerations References

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Halbert, T., & Ingulli, E. (2012). Law & ethics in the business environment (7th ed.). Mason, OH: South-Western Cengage Learning. Borgerson, J., & Schroeder, J. (2002). Ethical issues of global marketing: Avoiding bad faith in visual representation. European Journal of Marketing, 570-594. Business Dictionary. (n.d.). Retrieved 11 23, 2013, from http://www.businessdictionary.com/definition/stakeholder.html#ixzz2lUflQhGB Fisher, C. D., Schoenfeldt, L. F., & Shaw, J. B. (2006). Human Resource Management. Boston: Houghton Mifflin. Keeping Watch Over Direct-to-Consumer Ads. (2013). Retrieved 12 12, 2013, from The Food and Drug Administration: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107170.htm Laczniak, G., Bowie, N., & Klein, T. (2005). Ethical Marketing. Upper Saddle River, New Jersey: Pearson Prentice Hall. Lamb, C. W., McDaniel, C., & Hair, J. J. (2010). Marketing. Ohio: Cengage Learning. Milkovich, G. T., & Newman, J. M. (2008). Compensation. McGraw Hill Companies, Inc. The Food and Drug Administration. (n.d.). Retrieved 12 12, 2013, from Pharmacy Compounding: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompo unding/ucm339764.htm