Legal and Ethical Considerations in Marketing, Product Safety, and Intellectual Property
1. Ethical Issues Related to Marketing and Advertising, Intellectual Property, and Regulation of Product Safety
The principle of due care to consumers holds that pharmaceutical companies have the responsibility to make drugs that are safe for the patients (Boatrigh, 2006). A drug is deemed as safe if its related risks are known to and ruled by the consumers as acceptable and reasonable in view of the benefits they expect to receive from using it. Drug manufacturers, on the other hand, must comply with their part of the free agreement by manufacturing products whose risks are no greater than those expressly communicated to the consumers. All drugs involve
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Advertising features information that the consumers need to make informed decisions about their health (Connors, 2009). It is by being exposed to information related to a prescription drug that patients are able to have options that are not limited to those that their physicians can provide them. DTC marketing allows the consumers to be involved in their medication, which they can better do if the needed resources are readily …show more content…
John, a former employee at PharmaCare reports that the pharmacy advertises the drug directly to consumers, medical facilities, and physician offices, and distributes it in bulk. Whereas the Drug Quality and Security Act (DQSA) passed on November 27, 2013 allows a compounding pharmacy to supply to multiple clients and, therefore, distribute drugs in large quantities, it requires this type of pharmacy to adhere to the Current Good Manufacturing Practice (CGMP) standards (USFDA, 2015b). CGMP regulations hold that a drug should be safe for use, and that it contains the ingredients and potency it claims to have. Further, Section 503B of the said law states that an outsourcing facility may only compound in bulk those drugs that are in the drug shortage list by the FDA. The case study does not mention SD23 as being included in that list. FDA inspectors have the authority to inspect the drug distributed through CompCARE and the facilities and equipment used to manufacture the drug for which it has applied for approval. If it will be proven that the company violated the regulations, FDA can issue a warning letter or initiate other regulatory actions against