Compassionate use of and expanded access to new drugs for drug-resistant tuberculosis

Int J Tuberc Lung Dis. 2013 Feb;17(2):146-52. doi: 10.5588/ijtld.12.0017. Epub 2012 Dec 4.


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.

Publication types

  • Review

MeSH terms

  • Antitubercular Agents / therapeutic use*
  • Compassionate Use Trials / methods*
  • Drugs, Investigational*
  • Humans
  • Tuberculosis, Multidrug-Resistant / drug therapy*


  • Antitubercular Agents
  • Drugs, Investigational