FDA Approval and Regulation of Pharmaceuticals, 1983-2018

Study notes that from 1983 to 2018, legislation and regulatory initiatives have substantially changed drug approval at the FDA, so that it has shortened its review times, but at the cost of accepting less data and more surrogate measures.

An editorial discusses if this study raises a concern over whether, the search for new cures has weakened the evidence base for clinicians without yielding sufficient benefit for patients. It notes that the overall picture is not of a struggling FDA, but rather of a regulatory process that has evolved over time into a mass of special programs, flexible review criteria, and generous incentives. As a result, it is challenging to understand the totality of these reforms on drug approval in the US, though it is recognized that improvements can be made. It list 4 places for reform to enhance the benefits and value and reduce the inefficiency and risks of the US system of drug approval.