The Food and Drug Administration, also known as the FDA or USFDA, is responsible for protecting and advocating public health. They are the official government agency that ensures our drug supply is safe and effective. This is achieved through the regulation and supervision of food safety, dietary supplements, veterinary products, cosmetics, vaccines, biopharmaceuticals, medical devices, prescription and pharmaceutical drugs that can be purchased over- the- counter.
When a pharmaceutical company creates a new drug, it has to go through the FDA and is required to submit a New Drug Application (NDA) to the FDA. The FDA reviews the application to assure that there is an objective proof that ...view middle of the document...
Phase 1 Clinical Studies - Phase 1 includes the initial introduction of an investigational new drug into humans. During Phase 1, sufficient information about the drug’s pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies.
Phase 2 Clinical Studies - Helps determine the common short-term side effects and risks associated with the drug.
Phase 3 clinical studies - Intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug.
There are multiple health concerns worldwide and more and more drugs are needed every day. Many drugs however, are extremely expensive to develop, test, and produce. According to the Tufts Center for the Study of Drug Development (2002), it costs up to $802 million to bring a new drug to the market. In 2002, pharmaceutical companies spent $34 billion in research and development (Center-Watch, 2003). In addition to the costs, the overall time from the discovery to approve and market the drug can take up to 15 years.
Although the FDA prolongs this process for safety concerns, I personally feel that they should be able to expedite their approval. The reason for expedition is because more and more people are being diagnosed with multiple health issues. Some people are more desperate then others and feel they can benefit from the drug as it is. Therefore, if a person wants to take a drug that has not been approved yet, then they should be able to decide for themselves. However, the person should be informed of any possible dangers and legal issues before in-taking the drug.
It is understandable that the USFDA has a strict...