The Food and Drug Administration (FDA) is the governing agency responsible for the approval of drugs in the United States. The FDA requires a strict sequence of testing guidelines are met before this is possible. The journey to bring a new drug to market is not a short process. In n JABFM (2001), it states that “on average it takes 8 to 12 years and a cost of nearly $2. 6 billion to research and develop a new medicine, including the cost of failures. “Only 5 in 5000 drugs that enter into preclinical testing progress to human testing, and only 1 of these five tested on people are approved” (MedicineNet. com, 2015, pp. 1).
The first of several phases in the process of drug development is the preclinical phase that takes approximately 1 to 2 years. This stage of the process is the laboratory and animal testing for the purpose of assessing the safety and bioactivity of the drug. If successful, an investigational new drug (IND) application is submitted to the FDA. The results of the preclinical testing are used to help support the IND application for approval. After the IND application is approved, the next steps are clinical phases 1, 2, and 3.
Phase I is the first of human testing of a small group of 10 to 100 healthy volunteers for about three years. In this stage, the purpose is to assess the safety and dosage of the drug. If the compounds are deemed safe, enough they will progress on to Phase Two. ”Phase II involves 50 to 500 patient volunteers who suffer from a condition the drug is intended to treat be evaluated for effectiveness or therapeutic effect and safety of the drug and takes approximately 2 years” (Turley, 2014).
Phase two is where some drugs fail to either be effective or are deemed unsafe. NEW PHARMACEUTICALS 3 Phase III is the final stage of the human testing process before seeking FDA approval. It is here that researchers try to confirm their findings in previous phases. This phase involves several hundred to several thousand patient volunteers across multiple sites for 2 to 10 years. “During phase III, the drug is administered to several hundred or several thousand ill patients in exactly the way (dose, route of administration, frequency, etc. ) in which it will be used once it is on the market.
The performance of the drug compared to that of other drugs currently being used to treat the same disease to evaluate its relative effectiveness. In addition, double-blind studies with the drug and a placebo are performed, in which neither the patients nor the physician- investigators know which patients are receiving the drug and which patients are receiving the placebo (the control group)” (Turley, 2014, pg. 36). “Once a drug has received its final approval from the FDA, its ingredients, doses, manufacturing process, labeling, and packaging cannot be changed.
With further clinical trials, however, a drug’s indicated uses can be expanded” (Turley, 2014, pg. 37). The journey from creation to marketing is a slow and costly process, both financially and time to analyze the drug’s safety and effectiveness. The pharmaceutical industry is making great strides in finding new ways to for the therapeutic effectiveness of newly discovered drugs. It is my hope that one day soon the cure for cancer will be discovered and put an end to that devastating disease. NEW PHARMACEUTICALS 4 Reference Lipsky, M. S. , & Sharp, L. K. (0).
From Idea to Market: The Drug Approval Process. JABFM, 14(5), 364. MedicineNet. com. (1999). Drug Approvals – From Invention to Market – Medications: Prescription Drugs and Over the Counter Drugs. Retrieved from http://www. medicinenet. com/script/main/art. asp? articlekey=9877 Medscape. (2001). The Drug Approval Process. Retrieved from http://www. medscape. com/viewarticle/405869_4 Turley, S. M. (2014). Understanding Pharmacology for Health Professionals, 5th Edition. [VitalSource Bookshelf version]. Retrieved from http://devry. vitalsource. com/books/9781323059272/id/ch2fig.