Baxter’s Heparin Problems May Have Connection to China Supplier

Baxter’s (BAX) heparin product, lately in the news because of recent side-effect problems, sourced its active pharmaceutical ingredient from a US supplier who, in turn, manufactured the drug in a China subsidiary. Even worse, the FDA was supposed to inspect the subsidiary, but some snafu prevented the inspection from ever taking place.

It’s not surprising that the manufacturing plant hasn’t received an FDA visit: only 7% of overseas pharma manufacturing plants whose products end up in the US will see an FDA inspector in any given year. It would take about 14 years for each plant to be inspected – if there were no additions to the roster of overseas facilities. Given the number of additions and deletions to the list, it would take considerably longer.

So far in 2008, the FDA has received 350 reports of problems that may have been caused by Baxter’s heparin, a blood thinner that has been in use since the 1930s. Of the 350 incidents, 40% were termed serious, such as septic shock, and there are four deaths associated with the drug, though the causal link has not been definitively established.

In response to the side-effect outbreak, Baxter several weeks ago recalled nine lots of multi-dose injected heparin, but that remedy did not contain the problem. On Tuesday, the company suspended use of all its vials of multi-dose injected heparin, though the single-dose injected forms of the drug remain on the market. Baxter supplies about 50% of the heparin used in the US, making shortages a possibility.

At the moment, neither Baxter nor the FDA knows for certain that the China facility caused the problem. Baxter says it made an inspection of the plant within the last six months and found nothing amiss.

Baxter did not release the name of the owner of the facility, which was located near Shanghai.

The side effects of pharmaceuticals and active pharmaceutical ingredients imported from China was a big story in 2007. Lately, the news flow has included more items about treaties between the US and China and stationing inspectors in China (and other countries) to prevent similar problems from occurring, putting a more positive spin on the ongoing story. However, with this incident, the fears move back to the forefront.

Disclosure: none.

Comments

[huangthomas]

Each Chinese facility should be inspected at least once a year because they are notoriously unreliable. The cost of inspection should be born by Chinese pharmaceutical companies. US taxpayer pay for only those fascilities in the US for a very simple reason: it create jobs here.