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The precautionary principle adopted by UN Charter is very vital for the protection of consumers before drug and food substances are supplied to the market. The principle states that lack of scientific evidence should not be used as an excuse for failing to take action to prevent the occurrence of an injury. In line with this theory, the USA government has adopted a regulation that has established a procedure for evaluation and mitigation of risk emanating from new pharmaceutical products before reaching the market. (Aitken 2009)
This process is achieved through a risk management system.The approach involves a set of benchmark actions and interventions that are intended to recognize, distinguish, prevent or curtail risks associated with medical products. The major aim of the system is to ensure that the identifiable risks in a medical product are minimized for safety of the population while increasing the benefits to users. The process also involves the assessment of products efficacy in the purpose it was intended for. (Lilly 2009)
The Food and Drug Administration Agency has stipulated several procedural regulations that ensure that the new products in the market are safe. This is achieved by immediately evaluating the drugs. This is meant to determine the efficiency of a given dose as per the standards. The phase also includes meeting with the FDA personnel who ensure that the given end point requirements are reached by the manufacturer. (European Medicines Agency 2005)
The FDA also issues an application form called New Drug Application. From the form, the toxicology process planned by the pharmaceutical company is evaluated to determine its effectiveness. According to the WHO requirements, the company must give detailed information on its production procedure such as the applied technology and raw material sources all of which must be approved by the authority. (European Medicines Agency 2005)
The next phase basically involves clinical trials and laboratory screening. The process can be expensive incase of screening failure or if it involves complicated end points such as osteoporosis assessment unlike simple ones like cholesterol measurements. To ensure competency in the process, most companies will hire a research organization to handle project study. This is due to the fact that some of the instrumentation required for dexa scanning for osteoporosis may not be readily available. To ensure integrity in the process, the regulatory agency has a guideline that governs the procedures to achieve an efficacy in the study. The study has to have a clear end result on the criterion of the disease under investigation and also include the information to appear on the product’s label upon approval. (Strom 2006)
In reducing risks of new pharmaceutical products in the markets, the state authorities have regulation on the packaging and labeling of the medical products. The product label must indicate the side effects of the drug and the patients who should not use it under a given circumstance. (European Medicines Agency 2005)
The drug manufacturing companies must present their new products to be compared with the placebo already in the market. This helps in determining the effectiveness of the new drug. However, it important to note that even though a new product can have an efficacy which is at par with the market leader drug some will need frequent supervision for better safety and tolerance maintenance. (Lilly 2009)
The last phase adopted for consumer protection takes place after the approval of the product. In involves answering questions on how best the products already in the market can be improved. The study is important to the pharmaceutical companies as it can be used to improve the labeling to add more information or the warning, thereby minimizing the risks to users. (Aitken 2009)
Its no doubt that FDA has continued to play a very vital role in ensuring that pharmaceutical companies do not pose any risk to the consumers through new drugs supplied into the market. However, the worry is that according to international studies various geographical regions have differences in their efficacy and safety standards some of which could pose danger to users. Therefore, it is upon FDA to ensure that all the loop holes through which sub standards products could find their way in to the US markets are sealed.
References List
Aitken, M.L, 2009, The Emerging Influence, World Pharmaceutical Frontiers, Web.
European Medicines Agency, 2005, Guideline on Risk Management Systems for Medicinal Products for Human Use, Web.
Lilly, 2009, Lilly Reports on Outcome of Phase III Study of Arzoxifene. Web.
Strom, B.L 2006, What is Pharmacoepidemiology? Textbook of Pharmacoepidemiology. Web.
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