Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Every company can use a good spin doctor from time to time, and it looks like the Food and Drug Administration (FDA) is no exception.

Last month I told you that California Rep. Harry Waxman, who serves as head of the House Oversight and Government Reform Committee, raised concerns that items outlined on the FDA’s 2007 priorities list appeared to prioritize industry desires over consumer protection.

This, just months after more than 80 American deaths were linked to tainted heparin that was made in Baxter International Inc.’s facility in China. FDA officials later acknowledged they had not inspected that facility and claimed they had insufficient staff and financial resources to regularly inspect overseas manufacturers.

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Australia-based Alchemia, a biotechnology company specializing in synthesis and manipulation of carbohydrates, announced on its Web site that it is on target to launch its antithrombotic drug, generic fondaparinux. Generic fondaparinux targets the multi-billion dollar heparin drug market. The company claims fondaparinux has a superior safety and efficacy profile to the market-leading drug Lovenox. Meanwhile, the brand-name fondaparinux drug Arixtra, made by GlaxoSmithKline (GSK) continues to gain market share.

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