Word: generics
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...During the debate, some generic companies went to Capitol Hill with a concern: BMS was asking the FDA to approve a new interpretation of the agency's rules that, if successful, would allow it to use the findings from its pediatric study - for which it already received six months of additional monopoly - to keep generic versions of the drug off the market for an extra 3 years. The reason? FDA regs entitle companies that change their labels due to new research to have an extra three years of exclusivity. BMS argued that since data gleaned from its pediatric study...
...including products like Pfizer's anti-seizure medication Neurotonin, with revenues of $2.5 billion per year, most realized a fix was needed, and other brand-name drugmakers didn't like the notion of an exemption for BMS. The Senate approved a bill with a provision clarifying that generic drugmakers can sell their version of a drug in an adult form even if the brand- name maker has changed its label by adding new pediatric information. The House bill that passed in committee has similar language; a vote on the House floor could happen Tuesday. But generic drugmakers and other opponents...
...With 14 generic companies lined up to start making generic Glucophage, consumers stand to benefit greatly if BMS is not successful with its unorthodox interpretation of FDA rules. Analysts believe the price of the product, whose generic name is metformin, would plummet immediately by at least 30%, with greater price cuts as time passed...
...PATENT Bayer holds the patent on Cipro until 2003. Despite congressional pressure and news that Canadian health authorities have decided to break Bayer's patent, HHS decided against permitting other companies to make generic versions of Cipro. It maintained that Cipro (Bayer is tripling production) as well as other antibiotics, would be sufficient to meet any bump in demand...
...under different names across Europe. U.S. Secretary of Health and Human Services Tommy Thompson said negotiations were underway with Bayer to relax its patent on Cipro; the company wouldn?t comment. No wonder: a month?s supply of Cipro retails for a steep $350 in the U.S., while the generic version in India costs about $10. The Cipro patent has expired in Germany but will run until December...