Thepharmaceutical industry creates, prepares, and markets medicationsand authorizes pharmaceuticals for utilization. Pharmaceuticalcompanies are permitted to deal in branded or generic medicines andmedicinal devices. They are liable to a mixture of laws andregulations in regards to the licensing, testing and guaranteeingwellbeing and adequacy and promoting of drugs. Research anddevelopment of bringing the new RU-32 drug to market can be costly,and there are strict regulations and requirements that all companiesmust follow in most countries.
Theprimary concern with the failure of the FDA approval is the loss thatthe company will incur due to The Cost of Innovation. The time, moneyand effort invested by the company and researchers in the developmentof the new RU-32 drug were hoping to develop a drug that would helpin stabilizing insulin level. The Drug passed the first two faces ofthe FDA trials. On the other hand, during Phase III clinical trials,startling complexities emerged, and support by the FDA resulted tonegative (Friedhoff 81).
TheFDA may fail to approve a drug if the side effects outweigh thebenefits (Friedhoff 82). However, after some years, drugs that wereapproved by the FDA still caused some serious side effects (Friedhoff17). Why does the FDA approve such drugs? What does this say aboutthe legitimacy about the FDA? This means that maybe the FDA did checkit thoroughly at the time but once they approved it, the companymaking the product started changing its ingredients or somethingsecretly. This means that approval or disapproval does not adequatelyprotect citizens. Hence, the new RU-32, being a low cost andeffective drug should not go to waste (Friedhoff 106).
ThirdWorld Countries go for low cost but effective drugs regardless oftheir effects (Geest and Susan 33). Poorer nations urge theirmedication organizations to make less expensive branded ones or useother tools available at their disposal level to help them bring theprice of medication low. In any case, they face enormous pressurefrom global establishments and multinational pharmaceuticalorganizations, even when generics and other options pursued areillegitimate under international rules (Geest and Susan 13).
Formultinationals, they have invested billions into some of thesemedications thus, if disapproved by FDA, they need a patentframework that will ensure their ventures do not go to waste.Nevertheless, if the company approves the new RU-32drug to the ThirdWorld countries, yet being aware of the side effects reported by theFDA, it would be risking its ethics versus pursuit for profit. Manypharmaceutical companies face controversy after dumping old orunsuitable drugs into poor countries as aid and charity whileavoiding losses. Poor results or side effects can result to a badreputation of the organization (Geest and Susan 76).
Inconclusion, the team of researchers behind development of the newRU-32 should revise the results incurred at Phase III of the FDA testto find out the reason behind the FDA disapproval. If the problem iswithin the ingredients, the research team should change theingredient. Conversely, if the issue is on the side effects, theresearch team should figure out how to neutralize these side effects.However, this means additional time and money consumption. Moreover,the scientists should write a report weighing the benefits againstthe harm caused by the new RU-32. If the benefits outweigh the harm,the company should consider reaching the Third World Countriesmarket. However, if the harm outweighs the benefits, more researchshould be done on the new RU-32 to come up with a quality drug.
Friedhoff,Lawrence T. NewDrugs: An Insider`s Guide to the Fda`s New Drug Approval Process, forScientists, Investors, and Patients.New York: Pharmaceutical Special Projects Group, 2009. Print.
Geest,Sjaak , and Susan R. Whyte. TheContext of Medicines in Developing Countries: Studies inPharmaceutical Anthropology.Amsterdam, the Netherlands: Het Spinhuis Publishers, 1991. Print.