Intended for healthcare professionals


Are drug regulators really too slow?

BMJ 2017; 357 doi: (Published 29 June 2017) Cite this as: BMJ 2017;357:j2867
  1. Thomas A Marciniak, physician1,
  2. Victor Serebruany, professor2
  1. 1Bethany Beach, Delaware, USA,
  2. 2Johns Hopkins University, Maryland, USA
  1. Correspondence to: T A Marciniak thomas.a.marciniak{at}

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 Food and Drug Administration gets drugs to market faster than other major regulators.1 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 cardiorenal division, allegedly one of the agency’s “least efficient” (slowest).2

Potential for delay

Critics portray the “new drug application” process as wholly in a regulator’s hands.2 But this crude depiction ignores industry’s contribution to the clock after clinical trials are completed but before the FDA receives the formal application. It also depicts the FDA as a monolith, whereas licensing has two distinct elements: FDA scientific review and the subsequent decision making by FDA management.

We assessed the time attributable to drug companies, FDA scientists, and FDA management for all novel drugs approved by the FDA’s cardiorenal division during 2011 to 2015.3 Using date information from documents posted on Drugs@FDA and trial publications, we assigned drug company time as the period between last patient visit in the final pivotal trial to submission of an approval application; FDA scientific review time as application submission to completion of the primary clinical reviews; and FDA management time as the remaining time to approval (or non-approval) action letters.

Drug companies: eight months

Drug companies took a median eight months (mean 12 months) after the completion of …

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