Business Ethics Pharmaceutical Regulation

Question: Discuss about the Business Ethics for Pharmaceutical Regulation. Answer: Introduction: The main ethical issue that has been identified as per the provided case study is that the FDA approved Betaseron for the treatment of the MS patients who had a relapsing-remitting course of the disease and were ambulatory. However, it has been found that as per the clinical studies, Betaseron implies that it helps to diminish the severity and frequency of exacerbation in the MS patients along with a relapsing-remitting form. It has been noticed during the research that some flu-like side effects are frequent among the MS patients who are being treated with Betaseron. In addition to this, irritation and swelling around the injection is also considered as a common factor for the particular patients (Harpaz, et al., 2013). Nevertheless, these side-effects intended to decrease with the passage of time during treatment. However, it has been found that some MS patients have committed suicide after they received Betaseron as it leads to depression. Therefore, it can be said that to use thi s drug is an ethical issue. In addition to this, it has been found that Berlex was not prepared for the high demand of Betaseron. Thus, they asked Chiron Corporation who had been manufacturing the drug in little quantity for investigational use and did not have any facilities regarding manufacturing, to produce the drug in an expanded way. The reason behind this was that to get FDA approval for another company would take longer time. Thus, it is also considered as an ethical issue for the company and this might affect the patients. Therefore, it can be recommended that the company Berlex should consult with other companies for manufacturing the particular drug Betaseron and only after receiving the FDA approval the drug should be used for treatment of MS patients. The reason behind this is that a particular drug should be used only after its manufacturer gets the FDA approval as it is one of the rules and regulations that should be followed for welfare of the patients (Carpenter, 2014). References Carpenter, D. (2014).Reputation and power: organizational image and pharmaceutical regulation at the FDA. Princeton University Press. Harpaz, R., DuMouchel, W., LePendu, P., Bauerà ¢Ã¢â€š ¬Ã‚ Mehren, A., Ryan, P., Shah, N. H. (2013). Performance of Pharmacovigilance Signalà ¢Ã¢â€š ¬Ã‚ Detection Algorithms for the FDA Adverse Event Reporting System.Clinical Pharmacology Therapeutics,93(6), 539-546.