For the third time since 2008, when substandard Chinese heparin broke onto the scene, the FDA is considering raising quality standards to protect against API makers who don't mind killing someone to make a buck.
After a meeting last week, the FDA asked the U.S. Pharmacopeial Convention (USP) to draft new quality assurance standards that would include a heparin molecular weight determination procedure, reports inPharmaTechnologist. It also called for additional testing for oversulfated chondroitin sulfate (OSCS), which was found in the contaminated heparin, and suggested more control of nucleic acid impurities.
In February, citing patient deaths from tainted Chinese heparin, the FDA recommended that heparin manufacturers test crude heparin to make sure the ingredient comes only from pig intestines. The draft guidance also says manufacturers of the widely used blood clot prevention drug should audit their suppliers.
In early 2008, the FDA received reports of serious reactions, including deaths, from patients receiving heparin from Baxter International ($BAX), a major supplier to the U.S. market. An FDA probe found OSCS in batches of heparin and traced it to ingredients from China. "OSCS contamination of heparin appears to be an example of intentional adulteration, and has also been referred to as economically motivated adulteration--i.e., heparin appeared to be intentionally contaminated with OSCS to reduce the cost of production," the agency said in its document.
The FDA also has created a list of 22 Chinese heparin makers whose products are banned and can be seized if found coming into the U.S.
The USP, whose National Formulary publishes the standards drug manufacturers must follow in the U.S., is now accepting public comments on the proposed changes.
- read the inPharmaTechnologist piece
FDA asks heparin makers to test APIs for contaminants, including BSE
FDA triples list of banned Chinese heparin ingredient makers