Posted by Michael Wonder on 04 Jul 2017
Are drug regulators really too slow?
29 June 2017 - Regulators are often accused of delaying approval of new drugs by slow processes. Tom Marciniak and Victor Serebruany use FDA data to determine whether this view is justified.
Empirical analyses have shown the US FDA gets drugs to market faster than other major regulators. Still the agency finds itself the perpetual target of criticisms that it is too slow. Indeed, the 21st Century Cures Act that passed last year was promoted by those who perceive the agency as a bureaucratic behemoth that is hindering innovation. Could the agency speed up approvals without affecting patient safety?
We have taken a closer look at the facts, analysing the time from completion of clinical trials to eventual drug approval in the FDA’s cardio-renal division, allegedly one of the agency’s “least efficient” (slowest).
