FDA never inspected Chinese plant making Baxter's heparin

[Celebration]

http://www.chicagotribune.com/business/chi-thu_baxter_0214feb14,0,2081139.story

A Chinese manufacturing plant that was never inspected by the U.S. Food and Drug Administration could be the source of a potentially deadly allergic reaction experienced by hundreds of U.S. patients infused with Baxter International Inc.'s blood thinner heparin.

The FDA said it was still trying to determine why the Chinese plant under investigation was not inspected before it was allowed to ship the active ingredient in heparin to a Baxter-owned plant in Cherry Hill, N.J., where the drug is finished.

The product has been shipped for several years by a U.S. supplier near Shanghai that owns the plant. Neither Deerfield-based Baxter nor the FDA would name the U.S. supplier or the exact location of its plant.

"While no inspection of the facility has been conducted to date, preparations are being made to perform an inspection as soon as possible," the FDA said in a statement to the Tribune. "We have already requested expedited access to the facility, facilitated through a recently assigned agreement with the Chinese State Food and Drug Administration."

[MiniMe]

1. But God forbid that we get drugs from Canada, they might not be safe

What is wrong with this picture??

[TZ]

2. Why should this surprise anyone?

FDA doesn't have nearly enough staffing and funding to do all the inspections they need to do HERE, let alone overseas. I'm surprised Congress has not made funding a priority.

For all you herbal supplement types, remember your chinese herbs are not at ALL inspected as well.
And legally don't need to be. I would regard anything that comes from China that you ingest with EXTREME suspicion

[Celebration]

3. Not surprising to me

But, of course, the FDA said we can't get our prescriptions filled from other countries, because the FDA can't inspect the factories overseas.

Turns out our prescription drugs come from factories overseas, and they don't inspect those.

I say, if we are going to get poisoned by drugs from factories overseas, let's at least be able to pay less money for them.

And, if we are going to get poisoned by drugs from overseas anyway, we might as well be poisoned by over the counter items from overseas.

By the way, I just heard that Trader Joe's is going to stop importing food from China, because of customer demand.

If someone did that with herbs, vitamins, acetaminophen, and other OTC items, it would probably be a good marketing technique.

As far as regulation goes, I am fine with requiring country of manufacture on every ingested item, whether it is aspirin or turmeric.

[eilen]

4. This is really insane

considering a standard of practice to prevent DVT is to give an inpatient 3 subcutaneous shots of low dose heparin a day, and most of the patients I took care of have ports and central lines which are flushed with heparin. In addition to getting treated with chemo and dealing with those side effects, they may have been exposed to tainted heparin? Assholes. Who gets sued?

[bluhoodie]

5. The manufacturer is already being sued

although it's the FDA that should be.

... Because the plant, Changzhou SPL, has no drug certification, China’s drug agency did not inspect it. The United States Food and Drug Administration said this week that it had not inspected the plant either — a violation of its own policy — before allowing the company to become a major supplier of the blood thinner, heparin, to Baxter International in the United States.

Baxter announced Monday that it was suspending sales of its multidose vials of heparin after 4 patients died and 350 suffered complications. Why the heparin caused these problems — and whether the active ingredient in the drug, derived from pig intestines, was responsible — has not been determined.

The plant in Changzhou, west of Shanghai, appears to fall into the type of regulatory void that American and Chinese health officials are trying to close — in which chemical companies export pharmaceutical ingredients without a Chinese drug license.

China provides a growing proportion of the active pharmaceutical ingredients used in drugs sold in the United States. And Chinese drug regulators have said that all producers of those ingredients are required to obtain certification by the State Food and Drug Administration. However, some of the active ingredients that China exports are made by chemical companies, which do not fall under the Chinese drug agency’s jurisdiction.

From the NYTimes, today Feb. 16.
http://www.nytimes.com/2008/02/16/us/16baxter.html?ref=health