In addition when compared to other medications like anti-cholesterol drugs, these research and development costs are distributed over fewer patients who have shorter lengths of illness (Goozner, 2012). This fails to consider the fact that between 70 and 90 percent have ultimate clinical failures often occurring late in the FDA approval process (Woodcock & Woosley, 2008).
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In the U.S., cancer patients in particular are feeling the burden of increasing health expenditures. Surveys of oncologists show that 84 percent describe patient out-of-pocket spending affects treatment options. In other words, those who can pay for the latest drugs are the ones who receive them. The best therapies are thus not available for everyone; they are only available for those with adequate financial resources (Goozner, 2012). More importantly, costs are expected to rise another 27 percent by 2020 for new cancer drugs (Goozner, 2012). With some cancers increasing in incidence, this means some type of rationing of care will occur unless better and less costly treatments can be developed. In order to accomplish this, innovations must increase in addition to clinical success and approval rates (Woodcock & Woosley, 2008). This would meet the special needs of the cancer population by providing more options of care at lower prices.
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The process of new cancer drug development has several steps. The initial phase involves research of potential new drugs scientifically through empirical research. Once this has been shown to be beneficial, product design and delivery systems are then developed. Further refinements then occur in the preclinical and clinical phases of development which coincide with FDA approval steps. Only after all of these phases have been successfully accomplished does filing with the FDA for drug approval occur (Woodcock & Woosley, 2008). Unfortunately, issues of safety, utility and manufacturing are developed tandem through this process rather than in parallel.
