Heparin Imbroglio Update: Congress, Baxter & Importation
Posted by Jacob Goldstein
February 22, 2008, 1:12 pm
As we’ve been going about our business for the last day or so, the Heparin imbroglio has been intensifying. A few noteworthy nuggets:
Congress is making noises about requiring pre-approval of foreign factories making ingredients for drugs sold in this country. Check out this statement from John Dingell and Bart Stupak, a pair of Michigan Democrats often critical of both the drug industry and the FDA.
energycommerce.house.gov
Stupak and Dingell also sent letters yesterday to the chiefs of FDA and HHS, and one to Baxter CEO Robert Parkinson asking if he knew that a Chinese factory that supplies raw materials for the company’s heparin hadn’t been inspected by the FDA.
No, the Baxter CEO didn’t know the factory hadn’t been inspected, the Chicago Tribune reported. The Chinese supplier was pretty distant from Baxter — a joint venture partly operated by a Wisconsin-based company that sold heparin ingredients to Baxter. “It’s not unusual for us not to know that the FDA hasn’t inspected a supplier to a supplier,” Parkinson told the paper.
So are imported drugs OK, or not? The FDA has long discouraged the importation of prescription drugs from other countries. Just this month, the agency told the mayor of Duluth, Minn., that plans to buy prescription drugs from overseas pharmacies “present a significant risk” for the city employees who would be taking the medicines. On the other hand, as the Motley Fool points out, heparin and other drugs sold in this country are often made with ingredients from foreign manufacturers that may never have been inspected by FDA.
For the record, it’s still not clear whether the ingredients made in China are causing the health problems that appear to be associated with Baxter’s heparin.
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