Industry, FDA, and World Health Agencies Boost Pandemic Preparedness

October 27, 2005

ePT--the Electronic Newsletter of Pharmaceutical Technology

Industry, FDA, and World Health Agencies Boost Pandemic Preparedness

With an increasing number of reported cases of avian influenza A (H5N1), the US Food and Drug Administration, world health agencies, and pharmaceutical manufacturers continue to step up preparations for a possible pandemic.

Honoring its previous announcements, Swiss manufacturer Roche (www.roche.com) has agreed to meet with four major generics companies about the production of its patented antiviral Tamiflu (oseltamivir phosphate). Teva Pharmaceutical Industries (www.tevapharm.com, Israel), Barr Laboratories (www.barrlabs.com, Pomona, NY), Mylan Pharmaceuticals (www.mylanpharms.com), and Ranbaxy Laboratories (www.ranbaxy.com, India) will help boost supplies worldwide under sublicensing agreements.

Terence J. Hurley, Roche’s director of product public relations, says, “We’re starting production of Tamiflu in the US for the first time right away,” noting that several sites will be involved in the manufacturing. The production process will include a combination of existing Roche facilities and approved third-party vendors. The most recent FDA-approved site, announced by the company on Oct. 18 and in last week’s ePT, is a capsule manufacturing site, which will carry out alcoholic granulation, one of the final specialized production steps. Five other sites, previously approved by FDA, will be involved in the manufacturing. Hurley clarifies that a new facility will not be constructed.

This week, the World Health Organization released the agenda of its upcoming meeting entitled "The H5N1 Agenda: Towards a global strategy" to be held at its Geneva headquarters Nov. 7–9. The meeting will identify and address the challenges of controlling the spread of the H5N1 virus in animals, as well as preparedness efforts for a human influenza pandemic.

Also this week, FDA (www.fda.gov) announced the formation of a Rapid Response Team to ensure an adequate stockpile of anti-influenza drugs, including Tamiflu. Calling the US protection against an avian flu outbreak one of the agency’s “top priorities,” acting commissioner Andrew von Eschenbach, MD, said the Rapid Response Team approach could be used to “review a complete drug application in six to eight weeks.”

In collaboration with industry, Department of Health and Human Services, Centers for Disease Control and Prevention, and the National Institutes of Health, the Rapid Response Team will address roadblocks to product manufacture, support the design and conduct of clinical trials to test new potential treatments for avian influenza, and facilitate the development and availability of safe and effective vaccines, including helping increase manufacturing capacity of currently licensed vaccines against avian flu strains and facilitating the evaluation of studies that incorporate new technologies.