The process of developing and launching a new pharmaceutical product entails a series of steps aimed at improving the therapeutic range of products offered by a given company while observing the regulations stipulated by regulatory agencies such as the U.S. Food and Drug Administration (FDA).
As a result, successful development and launching of a new pharmaceutical product enables a company to; gain a competitive edge compared to different brands falling under the same therapeutic category, increase its market share, enhance its value, create an identity, supplement revenues, and to improve its overall productivity (Itkar, p. 12).
In this essay, we will look at the steps involved in introducing a new pharmaceutical product into the market including the clinical trials involving human subjects, the role of FDA in approving the new molecule, and the cost incurred by the company in developing and launching the new product.
Steps involved in bringing a new pharmaceutical product to the market
New pharmaceutical drugs also referred to as investigational drugs before approval, are subject to a four-phased clinical trial before marketing.
Phase I trials, which involve healthy volunteers, aim at investigating the safety of the new molecule and its interaction (concentration and duration in blood) with various physiological systems in the body. Subsequently, in Phase II trials, patients showing symptoms of the disease meant to be cured by the new product are recruited to evaluate the efficacy and safety of the new pharmaceutical product.
Conversely, Phase III trials are initiated in case the Phase II trials provide promising results. Here, Phase III trials involve a large population of human subjects whereby the clinical investigations aim at providing substantial evidence relative to the efficacy and safety of the new molecule.
This evidence gives the regulatory agency the opportunity to approve the new product for marketing. Finally, subsequent trials may continue after product approval whereby the Phase IV trials entail further evaluation of the side effects of the new molecule on the users besides assessing additional uses of the new product (Itkar, p. 10).
Steps in launching the new product
It is obvious that after the Phase III trials, the new pharmaceutical product is ready for clinical usage. However, it is not automatic that the new product will enter the market and fetch the required returns on investments. As a result, the company needs to analyze, plan, implement, and monitor the entry of the new product into the market.
Here, studies show that the process of launching a new pharmaceutical product follows a series of steps including market assessment, competitive assessment, assessing the market potential, product positioning and pricing, product promotional strategies, and monitoring product performance.
Sometimes, market analysts recommend that the company should repeat the whole process after the product has been in the market for at least one year or in case the product fails to give the expected returns (Itkar, pp. 12-14).
Overall, according to Collier (2009, p. 279), the total cost of developing and launching a new pharmaceutical product was averagely $802 million in 2003. However, with the rising cost of fuel and other economic hardships, most health economists note that the total cost incurred by a company in bringing a new pharmaceutical product into the market may increase to $1.3 billion or $1.7 billion.
Further, it is worth noting that the role played by FDA in approving new pharmaceutical products lies on the fact that federal laws require that new drugs must undergo a series of approval procedures as noted earlier.
However, since the sponsor undertaking clinical trials may wish to transport the new molecule to various destinations, the FDA is also charged with the responsibility of exempting the sponsor from the federal regulations. Here, the sponsor obtains technical exemption from the federal laws through obtaining the IND, which may be anything from an investigator IND, emergency use IND, or the treatment IND.
Furthermore, there are different categories of INDs including the commercial and research INDs. In most cases, IND applications are required by the federal law to show the Animal Pharmacology and Toxicology Studies, the Manufacturing Information, and the Clinical Protocols & Investigator Information regarding the new Pharmaceutical product.
This essay offers an elaborate insight into the steps involved in bringing a new pharmaceutical product into the market. From the foregoing discussions; it is certain that the process of developing and launching a new product entails a series of steps ranging from research and development, clinical trials, FDA approval, market assessessment, competition assessment, product positioning and pricing, and monitoring the performance of the new product in the market among a host other steps.
Additionally, the discussions show that the cost incurred by companies in developing and launching new products is relatively high especially with the rising cost of fuel and the prevalence of various economic hardships. Overall, there is the paramount need for pharmaceutical companies to ensure that the process of developing and launching the new products observes adequate analysis, planning, implementation, and monitoring to avoid losses.
Collier, R. (2009). Drug development cost estimates hard to swallow. CMAJ, 180 (3), 279-280.
Itkar, S. (2007). Pharmaceutical management (3rd ed.). Mumbai: Nirali Prakashan.