Here are few brief news related to healthcare & pharmaceutical scenes for your update.

• US Consumer Group Urged FDA to Ban Rosiglitazone
• Sanofi-Aventis Expands Its R&D Presence in China
• US FDA to Establish Footprint Overseas

• US Consumer Group Urged FDA to Ban Rosiglitazone

A US consumer group – Public Citizen – has petitioned FDA to ban the diabetes drug rosiglitazone (Avandia by GSK) over its risks of heart and liver damage. In November 2007, GSK updated its prescribing information in consultation with Health Canada after a study published in the NEJM reported a 43% higher risk of heart attack for those taking rosiglitazone compared to people taking other diabetes drugs or no diabetes medication at all. Public Citizen said its has identified 14 cases of liver failure linked to Avandia, including 12 deaths, based on its analysis of suspected adverse drug reactions sent to the FDA.In the statement, GSK said it does not believe Avandia causes liver failure and that a review by an independent panel earlier this year said the liver risks were acceptable. The company added heart attack data is inconclusive and that Avandia is safe and effective, when used as directed. There was no immediate response from the FDA.
Earlier, the American Diabetes Association and a European counterpart unanimously advised doctors against using Avandia in updated treatment guidelines.
This controversies surrounding Avandia has been reported earlier in our eBulletin issue no 25.

 • Sanofi-Aventis Expands Its R&D Presence in China     

Sanofi-Aventis announced on October 21, 2008 the strengthening of its R&D presence in China, with the expansion of its R&D facility in Shanghai, the new establishment of a state-of-the-art Biometrics Center in Beijing, and the signature of a partnership agreement with the Shanghai Institutes for Biological Sciences (SIBS) for the discovery of breakthrough drugs for neurological diseases, diabetes, and cancer. This R&D expansion in China will allow the rapid growth of clinical programs and aims to encompass all activities, from drug-target identification to late-stage clinical studies.

• US FDA to Establish Footprint Overseas
 The US Department of Health and Human Services (HHS, http://www.hhs.gov/) has decided to send its first regulators overseas. China and India, will be the first Asian nations to receive FDA staff through the “Beyond our Borders” initiative.
 
Justifying the needs to open overseas offices, Mike Leavitt, Secretary of HHS stressed the need to better safeguard the supply of imported food and medical products to USA as the main reason. This will involve the implementation of product safety agreements with key trading partners, including China. The first overseas office will be in China after the US government successully secured formal approval from the Chinese government. Beijing will host the first FDA staff this year; and additional staff will be deployed to Shanghai and Guangzhou next year. 
The second overseas office will be in set up in New Dehli, India; with more being in the plan.  
The “Beyond our Borders” initiative has become more relevant in lights of the recent high profile safety issues with food and drugs exported to US shore presumably from countries like China and India. Such initiative allows FDA regulators and local authorities as well as industries of the host countries to improve safety efforts of their produce. There would be activities which help in the transfer of technical capabilities, improvement of audits and inspections, and driving the accreditation programmes.

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