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Free Content Compassionate use of and expanded access to new drugs for drug-resistant tuberculosis [Review article]

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Several new classes of anti-tuberculosis agents are likely to become available in the coming decade. Ensuring prompt access to these drugs for patients without other treatment options is an important medical and public health issue. This article reviews the current state of ‘compassionate use’ and ‘expanded access’ programs for these new drugs, and identifies several shortcomings that will limit patient access to the drugs. A series of five steps is outlined that will need to be taken by national health bodies, international agencies and non-governmental organizations to prevent undue delays in access to new tuberculosis drugs for patients who could benefit from them. Following these steps can ensure that patients will be able to benefit from access to these drugs, while minimizing the risk of emergence of resistance to the drug.

Keywords: expanded access program; import waiver; open enrollment trial; pre-approval access; pre-marketing access

Document Type: Research Article


Affiliations: 1: Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts, USA 2: Tibotec, Turnhout, Belgium 3: Stop TB Department, World Health Organization, Geneva, Switzerland 4: PATH, Washington DC, USA 5: Medical Service Corporation International, Arlington, Virginia, USA 6: HIV/TB Division, Bill & Melinda Gates Foundation, Seattle, Washington, USA 7: Partners in Health, Boston, Massachusetts, USA 8: Médecins Sans Frontières, Paris, France

Publication date: February 1, 2013

More about this publication?
  • The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on tuberculosis and lung health world-wide.

    Certain IJTLD articles are selected for translation into French, Spanish, Chinese or Russian. They are available on the Union website

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