Your March 15 Daily Dose article “Baxter facing challenges on heparin,” was a missed opportunity to provide factual information to healthcare professionals and executives about an important change related to new U.S. Pharmacopeia, or USP, standards for heparin.
In October 2009, the USP introduced a modification of the reference standard for heparin unit dose, which affected stated potency of the product. Additionally, they required a new assay, which has been difficult to implement. And the new methods have provided different results in some heparin products. Though your article mentioned only Baxter, in actuality nearly all manufacturers of heparin have faced challenges implementing the new standards and the new test method, as evidenced by the multiple companies listed on the U.S. Food and Drug Administration’s drug shortage list.
Unfortunately, your article provided an incomplete picture of an issue with important clinical consequence. As such, we would strongly encourage your readers to view infor- mation available on USP, FDA and heparin manufacturers’ Web sites.
Francois Lebel Vice president, global medical and clinical affairs medication delivery Baxter Healthcare Corp.