Monday, March 03, 2008

Don't Blame China...At Least, Not This Time

Here’s some news: Baxter is discontinuing an injectable hospital product because of problems with a third-party contractor it relied on to supply the active pharmaceutical ingredient.

Heparin? Who said anything about heparin?

We are talking about the neuromuscular blocking reversal agents Enlon (edrophonium) and Enlon-Plus (edrophonium/atrophine).

The Food & Drug Administration announced the discontinuation of the drug February 29. The agency keeps track of product discontinuations and shortages to help alert providers to the need to find alternative agents. At a time when cost-cutting and consolidation are industry wide imperatives, these notices have become routine.

Still, you will forgive us for perking up when we saw the announcement about Baxter’s product the day after the company formally recalled all remaining supplies of its heparin product in the US.

It turns out that not all supply chain issues involve Chinese raw material manufacturers.

In this case, the third party supplier is Akorn Inc., which produces edrophonium for Baxter in Decatur, Illinois. Akorn has had some compliance problems of its own, receiving a Warning Letter from FDA last year—and then a follow-up inspection raised more concerns.

Enlon fell into short supply soon thereafter, with the American Society of Health-System Pharmacists alerting members to the issue in December. And on February 18, Baxter sent a terse letter to the trade announcing the discontinuation of the product.

The company notes that there is no relationship between this issue and the heparin investigation.

We can think of at least three critical differences. First, this is purely a supply issue; there have been no unusual adverse events or other issues associated with the product on the marketplace. Second, Enlon is not a widely used product (though, unlike with heparin, Baxter is the sole source provider of the drug). And third, this is a case where the supply chain issue followed an FDA inspection—not, as with heparin, the embarrassing discovery that FDA failed to inspect the right supplier.

But it is a timely reminder that the complexity of the pharmaceutical supply chain is not entirely a function of globalization. After all, Decatur is only about 200 miles from Baxter’s headquarters in Deerfield.


Charley said...
This comment has been removed by a blog administrator.
Chris Morrison said...

All fixed, Charley. Thanks.

Charley said...

many thanks Chris.