Curing the antibiotic issue

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Typical market forces also play a role in the lack of pharmaceutical companies investing in antimicrobial discovery and development. Infections tend to be acute conditions and antimicrobials are fast acting and effective. Therefore, antimicrobials do not generally enjoy a large sustained market share as is common with drugs that chronic, long-term conditions such as diabetes or hypertension. Secondly, the long-term market potential of antimicrobials is limited by the inevitable development of resistant microbial strains.

Legislative action is necessary to stem the tide of pharmaceutical company departures from antimicrobial research and development and to stimulate the involvement of non-active companies. Primarily, policymakers must focus on adopting incentives to bolster investment in the discovery of new drugs, or the public health threat will become even more catastrophic.

What is needed is a multidimensional approach that incorporates marketplace, clinical, and economic incentives simultaneously to stimulate private sector investment and innovation with mechanisms to support current products as well as encourage the development of new ones. Current antimicrobials could be supported through the extension of patents, market exclusivity, or data exclusivity. Drug development could be spurred through changes in clinical trial and review and approval guidelines. The accelerated publication of updated guidelines for anti-infective clinical trials would provide much needed clarity and ensure the relevance of current guidelines, which would encourage innovative clinical trial designs that lead to a better understanding of drug effectiveness against resistant microbial pathogens. Additionally, antimicrobials against targeted pathogens could receive priority or accelerated review with a goal date of 6 months.

Incentives such as tax credits equal to 50% for research and development of novel antimicrobials and tax credits equal to 20% available for investment in property used for antimicrobial research and development would provide economic assistance to companies that develop and produce antimicrobials. Funding could also be provided through clinical trial grants that would assist small manufacturers in conducting clinical trials.  Grants could also be provided for the development of antimicrobials in an area of critical public health need but limited commercial potential.

Without decisive action, drug resistance can only get worse. Government-sponsored research and refinement of existing regulations and policies can help to address the overall problem of antibiotic resistance, and help reduce the cost of drug discovery and development. However, the key focus needs to be on industry action. Policymakers must enact legislation that creates incentives for pharmaceutical and biotechnology companies to remain active in the discovery of new antimicrobial drugs. New drugs are desperately needed to fight the bacteria that have become increasingly resistant to antibiotics. It is not possible to predict when an epidemic of drug-resistant bacteria will occur—but we do know it will happen.

Sam K. Theodosopoulos is an undergraduate at The George Washington University where he is a member of the College Republicans and the editor of the GW Young Americas Foundation blog.