Here are a few brief news related to healthcare & pharmaceutical scenes for your quick update.
• FDA Opens Offices in India
• Viagra’s Application for Change to OTC Status Withdrawn
? Never Ending IP Tussle with the Generics
• Pfizer to Buy Wyeth in a US$68 Billion Deal
• FDA Opens Offices in India
Following the opening of branch offices in China in late 2008, the U.S. Food and Drug Administration (FDA) opened two offices in India (in New Delhi and Mumbai). This is part of the “FDA's Beyond Our Borders Initiative” aimed at ensuring and improving the safety and quality of drugs and food products from India and China. 10 experienced officials will be deployed in India to work closely with local food and medical products industry to ensure that the safety and quality of their products exported to the US. India is ranked the 4th largest exporter of drugs and biologics, especially generic pharmaceuticals, to the US.FDA also plans to post personnel to several more countries in 2009 -- Mexico, South America, Europe and the Middle East.
• Viagra’s Application for Change to OTC Status Withdrawn
Pfizer applied to European Medicine Agency (EMEA) to switch the forensic classification of it’s erectile dysfunction drug, Viagra 50mg, from Rx to non-Rx (aka POM to P); but on 19 November 2008, the company officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wished to withdraw its application for a change to the marketing authorisation for the medicinal product Viagra 50 mg tablets. This withdrawal would certainly disappoint many “consumers” who have hoped to gain increased convenience in accessing to this famed “potion of love”. The full statement of EMEA is attached here for information.
? Never Ending IP Tussle with the Generics
Dutch customs seized a consignment of generic drug API sent by Indian generics producer Dr Reddy bound for Brazil on 04-Dec-08. The Dutch authority was alerted by a company (possibly brand-name drug producer MSD) which holds the patent in the Netherlands. The consignment containing 500kg of losartan potassium, an API used in MSD’s CozaarTM valued at €55,000 was detained for 36 days allegedly on suspicion of being counterfeit. The ingredient is not patented in India or Brazil and therefore could not be violating IP rights in those markets. In the end, the drug shipment was released and returned to India. Both India and Brazil were fuming over this incident and charged that trade in generics is fully legal worldwide - and governments and activists have been fighting to clear up any confusion between generics and counterfeits, which unlike generics might be substandard or illegal. Under the TRIPS agreement, medicines are considered to be generic based on the country in which they are meant to be commercialised, meaning either Brazil or India, they said. The law of the country of transit does not matter, Brazil argued.
• Pfizer to Buy Wyeth in a US$68 Billion Deal
In the biggest drug-company buyout in almost a decade, Pfizer is acquiring Wyeth for $68 billion in the part-cash, part-stock deal. On the job front, this deal was expected to trim up to 20 000 jobs and vastly diversify the products sold by the world's biggest pharmaceutical company. The anticipated job cuts were announced by the companies during a press conference, referring to a combined 15% reduction in jobs at the two companies. This news of job losses couldn’t have come at the worst of times as the world is struggling to deal with the deepest economic crisis yet; and much more so while both companies are US-based and the job losses in home turf is expected to exacerbate the unemployment woes in the US.
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