It is hoped that new registration mechanisms and economic incentives will encourage much-needed drug development
That there is a problem with antibiotic resistance is no surprise to clinicians who deal with antibiotic-resistant organisms in day-to-day practice. Scenarios increasingly being faced include health care-associated infections (particularly those acquired overseas) where few therapeutic options are available, bacteraemia following transrectal prostate biopsy, simple urinary tract infections for which no oral antibiotics are effective, and drug-resistant gonorrhoea, tuberculosis and typhoid fever. The inexorable rise in antibiotic resistance coincides with a dwindling pipeline of novel antimicrobial agents under development.1,2 A recent review identified only two new antibiotics registered in the United States since 2009 (of which only one is currently available in Australia) and only seven antibiotics active against gram-negative bacteria in clinical development.3 Only four multinational pharmaceutical companies were engaged in the development of antibacterials; barriers to development and registration of new antibiotics were noted (including the need for large efficacy and safety trials), as was low profitability relative to other drugs.
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Allen Cheng is a member of the TGA’ s Advisory Committee on Prescription Medicines. The views outlined here do not necessarily reflect the views of the Committee or the TGA.