In recent days, there has been a lot of attention focused on the Food and Drug Administration’s (FDA’s) drug approval process. Last week, during his first address to a joint session of Congress, President Trump stated that “our slow and burdensome approval process at the Food and Drug Administration keeps too many advances…from reaching those in need.”
FDA advocates were quick to respond, citing considerable declines in FDA review times over the last several years, from 27 months in 1993 compared to 10 months in 2016. Why such a divergence? Because there is a fundamental and dramatic difference between the time and cost of drug approval and drug development.
There is a fundamental and dramatic difference between the time and cost of drug approval and drug development.
While it may take FDA months to review a new drug application, the bigger concern is the fact that it takes more than ten years and $2 billion to develop a new drug from a molecule to a medicine, so that it can be made available to patients in need.
And every stage in this process is governed by FDA regulations, including laboratory-based research, pre-clinical studies, and clinical trials testing in human subjects. This is followed by the review and approval process, which requires submission of voluminous documentation and data to determine efficacy and risks.