Thursday, January 12, 2012

FDA probing J&J delays in reporting serious injuries among users of its Animas insulin pump -

David Rosen, a former FDA staff member who's now an attorney at Foley & Lardner LLP advising clients on FDA regulatory issues, said companies must continuously evaluate a product's safety over its life span.

"A company the size of J&J should have infrastructure in place to process, review and classify complaints, because they could be indicative of a larger issue with the product," he said. "It's a little disconcerting that they didn't have their act together in that regard."

The problems follow a string of nearly 30 product recalls announced by New Brunswick, N.J.-based Johnson & Johnson from September 2009 through last month. They have included millions of bottles of Tylenol, Motrin and other nonprescription medicines for children and adults, prescription drugs for seizures and HIV, faulty hip implants and contact lenses that stung the eyes. Reasons for the recalls ranged from contamination with metal shards and glass particles, to nauseating odors and inaccurate levels of active drug ingredients.

"Any company can have one of these things pop up and smack them, and you can have a bad coincidence when two of them come and smack you three weeks apart. But it's not bad luck when you have" this many, said Erik Gordon, a professor and analyst at the University of Michigan's Ross School of Business. "The amazing thing is that Bill Weldon still has a job."

Posted via email from Jack's posterous

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