New experimental drugs are being developed daily by pharmaceutical companies, each looking to make the next big drug that will bring about big results, and big profits. The process to get those drugs to market is an arduous and costly one and drug companies have a long way to go, however, before their efforts ever see the light of day by the general public. Working to understand this process, the role of the FDA (Food and Drug Administration), the costs associated with the process, and the delicate aspects of human testing, serve as a means of providing insight into a process that, while fascinating, is not typically a part of common knowledge.
The introduction of a new “medication to the US commercial market follows a complex process that may extend may years from the initial discovery of the putative drug through FDA approval and final market launch” (Targum & Milbauer, 2008, p. 57). This process consists of several broad steps, each lasting for years: preclinical testing, investigational new drug application, Phase I clinical trials, Phase II clinical trials, Phase III clinical trials, new drug application, and Phase IV studies (Lipsky & Sharp, 2001). The average amount of time for all steps to be completed is 12 years (Drug Approvals – From Invention to Market…A 12 Year Trip, 1999). Since 2003, the cost to develop a new prescription drug has increased by an average of 145%, coming in at, on average, $2.6 billion dollars for a drug that gains market approval; this does not include any drugs that do not reach this stage of the process (Mullin, 2014). With figures this high, it is unsurprising to find that the process is a complicated one.
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In the preclinical testing phase laboratory and animal studies are completed in order to determine both the safety of the drug and the effects of the drug itself (Lipsky & Sharp, 2001). The FDA steps into the picture at the second step of the process. The investigational new drug application is submitted to the FDA for the purpose of explaining to the FDA the types of trials done on animals and in the laboratory and serves as a means of presenting information to the FDA on the process that will be used for the Phase I and Phase II trials with human participants (FDA, 2015). The FDA must sign off on these processes before they can be started (FDA, 2015).
Phase I and Phase II of human trials allow the company to work to ensure that the drugs operate as intended within human subjects, though Phase II studies are only started if Phase I does not reveal unacceptable levels of toxicity (FDA, 2015). Phase III trials are those that are submitted to the FDA; they are on the greatest scale and provide the most data regarding the manner in which the drugs interact with the human system (Lipsky & Sharp, 2001). The information from the Phase III trials is submitted to the FDA along with the new drug application; the FDA will review that information and determine if more information is needed and whether or not the drug will be approved for sale (Lipsky & Sharp, 2001, FDA, 2015). If the drug is approved for sale, the final step, Phase IV studies, will be conducted in order to ensure that there are no long term or previously unknown side effects as a result of the drug (Lipsky & Sharp, 2001).
Due to the high cost of bringing new drugs to the market, it is essential that each of the different phases is met with success, as failure can result in increased costs or even result in total losses for the company for that product. In spite of the rigorous testing that goes into the creation of each new drug placed on the market, there are still issues that may arise with the drug itself, showing up in Phase IV studies or even further down the road. In working to understand the correlation between pharmacology and medical treatment, understanding the process of bringing new drugs to the market is essential.
- FDA. (2015). The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective. Retrieved 20 March 2015, from http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm
- Lipsky, M., & Sharp, L. (2001). From Idea to Market: The Drug Approval Process. JABFP, 14(5), 362-367. Retrieved from http://www.jabfm.org
- MedicineNet,. (1999). Drug Approvals – From Invention to Market. Retrieved 20 March 2015, from http://www.medicinenet.com/script/main/art.asp?articlekey=9877
- Mullin, R. (2014). Cost to Develop New Pharmaceutical Drug Now Exceeds $2.5B. Scientificamerican.com. Retrieved 20 March 2015, from http://www.scientificamerican.com/article/cost-to-develop-new-pharmaceutical-drug-now-exceeds-2-5b/
- Targum, S., & Milbauer, A. (2008). The Process of Getting New Drugs to Market. Psychiatry, 5(8), 57-60. Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2695743/
