THE IMPACT OF ACCELERATED APPROVAL ON ONCOLOGY DRUGS AND THE APPARENT LACK OF DUE DILIGENCE BY PHARMACEUTICAL COMPANIES

Abstract

The accelerated approval program was introduced in response to a need for faster approval times for new drugs in patients with severe illnesses. The goal of this analysis was to determine if accelerated approval is beneficial and to address the strengths and weaknesses. This project gathered additional data and updated previous results from Johnson et al. (2011). Drug data in this study was collected and tabulated in a similar fashion to Johnson et al. (2011) for the following three years, from July 1, 2010 to July 1, 2013. The results show that the program has been very successful at getting new drugs to patients faster. The data provides, however, evidence that many drugs are remaining on the market for statistically significant periods of time without confirmatory trials to prove efficacy. This is attributable to a lack due diligence by pharmaceutical companies and an absence of clear rules by the FDA.