assignment 4 leg 500

Topics: Intellectual property, Pharmacology, Pharmacy Pages: 11 (2830 words) Published: January 25, 2015


Assignment 4
Leg 500
PharmaCare Company’s Study Analysis
Laquita Watson
Professor Frank Hatstat
Strayer University

1. Research three to five (3-5) ethical issues relating to marketing and advertising, intellectual property, and regulation of product safety and examine whether PharmaCare violated any of the issues in question. There is much ethical concern available which possibly relate to marketing and advertising intellectual property, and regulation of product safety. However, there are some common ethical concerns which must be included by any organization while framing these areas and with the focus of such concern organization can ensure an effective and legal ethical relationship. Marketing and Advertising:

Direct to consumer (DTC) advertising included a number of commercial advertisements which advertise through radio or television and few use to publish in newspapers as well as in magazines as long as also published on internet too. All have the same goals to make aware the customers about any prescribed drug, it’s the sole purpose of any drug advertisement. However, FDA has made it compulsory for every Company. They have to list the side effects in every ad of which they are going to publish. This responsibility is where companies like DTC, need to collaborate with its clients and confirm before advertising any drug. This is so that the customers themselves will be guided to understand before using any drug. Moreover, FDA expects that the prescribed drug maker should also provide the risk information in every promotion which must qualify as a product-claim advertisement. (Gab 2008) In the case of PharmaCare, where they didn’t follow the rules and regulations of FDA, it must be considered ethically to maintain the customers trust. They had advertised a non-prescribed drug ‘AD23’ that could directly affect any customer and shouldn’t be allowed to sale in market because it was a compounding drug which got reformulated without any prior approval through FDA, i.e. ethically wrong.

Intellectual property:
As we know, there are intellectual property laws which must be followed by any Company and/or by subsidiaries, i.e. no any subsidiary can break the rules of intellectual property. They can’t share the secret trade off as well as monetary gain to others. Within the case, PharmaCare is the parent company of CompCare; thus it’s PharmaCare’s responsibility to protect its own brand name as it had started its own subsidiary (CompCare) where they had reformulated AD23 without taking any proper approvals from FDA or through other required regulatory bodies; therefore, it’s an ethical issue because the intellectual property was used by the Company subsidiary. ( Davoren 2012)

Regulation of product safety:
 
Manufacturing companies have liability once their product leaves for sale into a market. They have to ensure that legislation is governed byproduct’s safety. The main ethical concern is that they have to ensure that the company has been providing only those products which have been tested for safety. The product safety engineers are expected to examine and test products to various standards and make sure that they have received the approval certification. This certification provides that the respective products are free of any harmful effects. (Gabb 2008) Within the case, CompCare got the information that continuously increased consumption of medicine AD23 which increased the rate of heart attack. Even after knowing the harmful impact the Company ignored the reality and had started taking bulk orders and earned more profit with one single product sale. Hence, there was an ethical issue related to the product’s harming effects of which they ignored the risk factor to gain the high rewards as well as an increase in the profit margins. ( Davoren 2012).

2. Argue for or against Direct-to-Consumer (DTC) marketing by drug companies. Provide support for your response. In the pharmaceutical...

References: (Gabb 2008). Pros and cons of direct-to-consumer advertising. Retrieved From: http://www.rxcomms.com/newsletter/pros-and-cons-of-direct-to-consumer-advertising/
Julie Davoren (2012). Pros and cons of direct-to-consumer advertising. Retrieved From: http://yourbusiness.azcentral.com/pros-cons-directtoconsumer-advertising-14119.html
Staff Writer (2012, January 18). Direct to Consumer Marketing. Retrieved From: http://www.drugwatch.com/2012/01/18/direct-to-consumer-marketing/
“STATE REGULATION OF COMPOUNDING PHARMACIES”. Retrieved From: http://www.ncsl.org/research/health/regulating-compounding-pharmacies.aspx
Steve Tobak (2014, Jun 18). Samsung and Korea’s Copy Culture. Retrieved From: http://www.foxbusiness.com/business-leaders/2014/06/18/samsung-and-koreas-copy-culture/
“Unapproved Prescription Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval”. Retrieved From: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/
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