Russia has been an epicenter of the TB epidemic, said Hamburg, but it is also a country with an extraordinary tradition of science and medicine. Therefore, holding a workshop on drug-resistant TB in Moscow is both symbolically and substantively important. In her presentation, Hamburg provided a global overview of the challenge of developing new TB diagnostics and drugs. She then outlined the role of regulatory science and the need for collaboration in efforts to meet this challenge.

THE GLOBAL CHALLENGE

The numbers of TB cases during the New York City TB epidemic (see Box 2-3 in Chapter 2) appear small compared with the current numbers worldwide, Hamburg observed. Yet the same principles that guided the response in New York City apply globally. TB must be detected in all its forms as early as possible, which requires focused attention on at-risk populations and on a host of social, economic, and clinical variables. Health systems must be strengthened through bold policies, and financial barriers need to be addressed and overcome. Success in controlling the epidemic will depend on the ability to develop and distribute better tools with which to prevent, diagnose, and cure TB, as well as to ensure the quality and safety of those products throughout the supply chain and their life cycle, said Hamburg. Regulatory authorities have an essential role to play in all these areas.

First, regulatory authorities must assure the quality of existing and new drugs and medical products. This assurance is critical to achieving the benefits of treatment and avoiding the further development of resistance because of substandard medications. An example of efforts to that end is ongoing collaboration between the U.S. Food and Drug Administration (FDA) and regulatory colleagues in Russia.2 Hamburg said that on the morning of her presentation at the workshop, she had met with her Russian colleagues to begin developing a blueprint for working together to share information and best practices. They also identified good clinical practice as a key area for partnership. A series of training workshops in that area will harmonize standards and approaches, which is particularly important as a growing body of clinical data emerges from Russian studies. In addition, opportunities for harmonization and standardization through such entities as the International Conference on Harmonization and other international

 

 

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2 The Statement of Intent on Collaboration between the U.S. Food and Drug Administration and the Federal Service on Surveillance in Health Care and Social Development of the Russian Federation (ROSZDRAVNADZOR) was agreed to on May 27, 2010. The agreement (Russian and English language versions) can be found at: http://www.fda.gov/InternationalPrograms/Agreements/MemorandaofUnderstanding/ucm217539.htm (accessed May 19, 2011).



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