Handling Heparin

Mar 19, 2008
By Pharmaceutical Executive Editors

FDA isn't yet ready to say that it knows why US patients died after taking the blood thinner heparin, but it has announced what sounds like a strategy for testing and controlling import of the drug in a series of cryptic poster-like documents.

According to one of these documents, FDA will issue an import alert for all heparin active ingredients and final products imported from "specified" manufacturers. The shipment will be detained until the manufacturer can supply documentation that "appropriate corrections" have been made. If the pharma supplier meets the criteria, the company and product will be removed from the alert list.

FDA did not return phone calls requesting clarification, but the document itself implies that heparin from Scientific Protein Labs in Changzhou, China?the manufacturer whose products have been linked to US deaths?will not be entering the country anytime soon.

Another cartoonish document maps out the path FDA will follow to identify what went wrong with the drug. A week ago, the agency revealed that it had found a previously unknown contaminant in suspect batches of heparin. The contaminant, a substance very similar to heparin, made up 5 to 20 percent of the batches in question and was identified with a series of nonstandard tests, including capillary electrophoresis and H-NMR spectroscopy. The new FDA document states:

  • FDA and industry are developing animal testing to determine if human adverse reactions are based on allergic reactions and to determine if there is a link to the contaminant.
  • FDA is working to identify lots linked to adverse reactions in humans with any corresponding contaminated lots.

Moving In
In related news, FDA announced that it would permanently station a team of full-time employees in China to work with local authorities and that it is considering sending employees to other countries in the future.

Although timing of this announcement appears to tie in with the heparin commotion, the feds did not say whether one had to do with the other.

"Our efforts to fill permanent FDA positions in China are a significant step toward ensuring access to safe food, drugs, and medical devices in the global market," stated Murray M. Lumpkin, deputy commissioner for international and special programs at FDA.

lorem ipsum