USP Releases Free Standards to Ensure the Safety of Medicines for Neglected Infectious Diseases

The United States Pharmacopeia (USP) has released free documentary standards for medicines used outside the United States to treat neglected infectious diseases. The standards are available on USPs Web site at http://www.usp.org/internationalStandards/ . "Public standards for such medicines are urgently needed to help ensure that patients in all parts of the world have access to good quality medications," said Roger L. Williams, M.D., USP executive vice president and CEO. "These international standards will make it easier for healthcare organizations in countries without sufficient regulatory and pharmacopeial resources of their own to ensure the quality and purity of medications."The World Health Organization estimates that 1 billion people “ one sixth of the worlds population “ suffer from neglected tropical diseases. Widespread counterfeiting and distribution of sub-standard drugs has worsened this situation. The initial two drugs included in the International Standards program are used in the treatment of HIV-AIDS: Abacavir Sulfate, and Efavirenz. These monographs are posted in draft form, with a 90-day period for public comment that ends on April 30, 2007. Instructions for submitting comments are at http://www.usp.org/internationalStandards/ . Monographs for drugs used to treat malaria will be added shortly as part of the ongoing program. USPs standards are widely recognized internationally as authoritative, science-based, and credible. They are developed through a process that is transparent and open to public comment. As the worlds only private pharmacopeia, USP has the unique ability to work across borders, giving it the ability to set voluntary standards for medicines used outside the United States.The worldwide public health benefits of the International Standards initiative include:§ Supporting the effort to provide quality drugs to patients with the greatest need; § Helping ensure that medicines for neglected infectious diseases in international commerce meet a high standard of quality This is a very important initiative, as the industry wrestles with effective ways to promote the development of more effective treatments for "neglected diseases".  For an interesting interview with Rachel Glennerster (executive director of MIT's Poverty Action Lab) and Michael Kremer (Gates professor of developing societies at Harvard University), whose book, Strong Medicine, came out about three years ago, click here. - AMS