FDA is an abbreviation for Food and Drug Administration and is a health agency in USA that is charged with the responsibility of promoting health through supervision of food and drug safety. The agency formulates and implements rules and regulation contained in section 361 of the public health act. FDA is also charged with the primary responsibility of approving drug substances in the US. The approval process is designed in form of stages that comprises of 4 phases. The first phase of approval is the pre-clinical phase where medical practitioners analyze the various compounds of a certain drug that have the potential of curing a certain disease. Various aspects of the identified compound viz. toxicity are analyzed and tested with humans or animals to ensure that they are not harmful. This is a rigorous process that usually takes up to 2 years. In the second phase, the drug is tested in minute number of humans and animals to see how well they are processed by the body hence come up with the right dosage. This is a one year phase. The process proceeds to the third phase only if the drug compounds in stage two were found to be tolerable by human and animal bodies. The primary aim of this face is to actually find out whether the drug can actually work and also to determine the short term effects. This takes roughly 2 years. The fourth phase takes three years and it purposes to detect any side effects of the drug substance. Finally, there is the fifth stage which entails the selling of the drugs that have obtained FDA approval. It is therefore clear that the FDA process is very rigorous. It has been met with a lot of criticism on the basis of being unethical in the business field.
Some researchers have considered the FDA approval process as an unethical business practice which is at times conducted with trial data that has not been published. This is hindering doctors from providing the most appropriate medication to their patients. They further argue that the authorities that are meant to protect the public from harmful drugs are paradoxically protecting illegal drug merchants and companies that are making huge profits in the health industry. The said companies are presenting fraud data as they seek for approval. This has been termed as immoral and unethical business practice as it has led to many disabilities and many deaths.
In America, studies are conducted with the aim of enlarging the market of a particular drug rather than for medical purposes. The approval process is designed in a manner to solicit FDA approval or to capture a significant market share and this has been considered as unethical and utterly fraudulent. It is imperative to note that drug substances are approved by FDA on the basis of dishonest and deceptive researches by drug manufacturers. The FDA approval process can therefore be seen to be market oriented whereas it is expected to be welfare oriented. Worthwhile noting, the results from fraudulent researches have been published in medical journals and other scholarly articles that are relied to a great extent by medical experts in approving any particular drug substance. Paradoxically, these sources of information are being used as marketing tools. This scenario is hindering dissemination of valid information that is imperative for providing sound advice to the approving authorities like FDA.
The FDA approval procedure has further been criticized on the basis that drugs that have already been approved using fraudulent data are still selling in the market even after realization of this fact. There is therefore a complete failure in terms of regulation. Moreover, FDA is not correcting comprehensive data for accurate approval and this is putting America at health risk due to lack of safety. Ironically, FDA is charged with the responsibility of ensuring health safety among the American people. FDA is also accused of what scientists call publication bias i.e. selective publication. Empirical literature has indeed observed that for 100 drugs that have been approved in the last 5 years in America, more than 50% of the studies that led to their approval have not been published which is a great failure. Scientists have also considered placebo drugs as very powerful and have proposed that placebo should only be used if and only if no other form of active cure is available. They have also unanimously agreed that the use of placebo in severe sickness is unethical. Unfortunately, FDA has proven reluctant in accepting and affirming such stipulations and has therefore been blamed for what has been termed as unethical behavior in medical profession.
In a nut shell, FDA approval process has proven to violate various codes of ethics in the medical field. These ethics have been compromised to give room for mega drug manufacturers to make huge profits at the expense of the health of American people. This is unethical business practice especially for a regulatory body like FDA that is charged with the responsibility of promoting people’s health. Appropriate steps and restructuring should be done to ensure that each ethic provision in the medical field is adhered to.