Feature Antibiotics

Speeding new antibiotics to market: a fake fix?

BMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h1453 (Published 25 March 2015) Cite this as: BMJ 2015;350:h1453
  1. Peter Doshi, associate editor, The BMJ
  1. pdoshi{at}bmj.com

Antibiotic development may finally be picking up pace, with 11 new drugs approved in the past decade, four in 2014 alone, with the help of new legislation. But in this first installment of a series on antibiotics, Peter Doshi asks why authorities are approving drugs with little evidence they do anything to tackle the problem of antimicrobial resistance

US president Barack Obama has called the problem of antimicrobial resistance “a serious threat to public health and the economy.”1 In the UK, Sally Davies, chief medical officer for England, declared the problem “as important as global warming,”2 and a “ticking time-bomb”3 while the prime minister, David Cameron, says: “we are in danger of going back to the dark ages of medicine.”4

Over the past few decades industry has turned its eyes towards the more profitable markets in chronic diseases—the blockbuster cardiovascular and psychiatric drugs, for example—and attention on much needed antibiotics has waned. This has resulted in fewer antibiotics able to keep up with the march of evolutionary resistance. Incentives for drug development have therefore become a key focus of efforts to tackle antimicrobial resistance, alongside improved infection control and antibiotic stewardship.

The Food and Drug Administration now offers a series of marketing incentives for new antibiotics. Backed by a law passed by Congress in 2012, 61 chemical entities have been granted “qualified infectious disease product” (QIDP) status, promising manufacturers accelerated review of new drug applications and five additional years of marketing exclusivity. Another bill introduced into the US Congress this year aims to substantially lower the requirements for FDA approval for certain new antibiotics, including the need for phase III trials, by allowing preclinical and pharmacokinetic data to serve as “confirmatory evidence” underpinning approval.5

So are the antibiotics approved under this new relaxed regime fulfilling …

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