Heparin drug manufacturer Baxter International faces some challenges in getting its product past a more rigorous drug-potency test established by U.S. Pharmacopeia, or USP.
The Food and Drug Administration last year had launched an investigation into the
deaths of two patients at a Delaware hospital to see if the deaths were tied to contaminated heparin products manufactured by Baxter. Separate tests conducted by Baxter and the FDA indicated that heparin was not the likely cause of the deaths.
The drugmaker has since been grappling with a new problem, an updated test that gives potency readings for the drug that are 10% higher than an older version, according to Baxter spokeswoman Kellie Hotz.
“It's taking us a bit longer than anticipated to meet the requirements of the new test. We've been having some challenges, and we've been talking with the FDA on how we can achieve this new USP standard, to adjust the drug amount to get within the range that's required,” Hotz said.
Hotz clarified that the heparin currently being tested is a pre-mixed product, and is not the concentrated vial product that was at the center of the FDA's investigation last year. “That's not something we're producing anymore,” she said.
The FDA is reporting that other heparin manufacturers are also struggling to meet the requirements of the test, but the product is on the market in other forms, Hotz said. It may be premature to say broadly that there's a shortage of heparin, she added.
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