Baxter waited 10 days to recall

Want to know what happens inside a pharma company during a recall crisis? Check out Sunday's Chicago Tribune, which details the behind-the-scenes scramble at Baxter as the company first found problems with its heparin product, then recalled millions of doses [1], then stopped production [2] and eventually recalled the rest.

CEO Robert Parkinson started having early meetings every morning, for one thing, and making surprise visits to key execs throughout the day--and that was how he found out that the FDA had never inspected the Chinese plant suspected as a source of the tainted product. One interesting tidbit in the piece: By the time the first doctor linked heparin with allergic reactions among patients at St. Louis Children's Hospital in early January, Baxter already had found nine suspect lots of the product, and adverse reactions were being reported at rates 20 times normal numbers. But 10 more days passed before Baxter issued the recall. The company wouldn't comment on why it delayed.

And the FDA doesn't come out of the story smelling rosy, either. Though the agency claims it has inspected every foreign plant sending medical products to the U.S., its own Science Board begged to differ, saying that millions of regulated products come into the country annually from foreign facilities that have never been examined by the FDA. "Unless the deficiencies can be addressed rather urgently," said board member Gail Cassell, an Eli Lilly VP, the heparin debacle "is not the last such situation. We will have more of them."

- see the Chicago Tribune article [3]

Related Articles:
Heparin suspected in more deaths. Report [4]
Heparin snafu prompts call for legislation. Report [5]
Heparin supply chain full of loopholes. Report [6]
Baxter stops making multidose heparin. Report [2]
Baxter recalls heparin on adverse events. Report [1]