Warning: contains FDA approved drug

The US Food and Drug Administration (FDA) doesn't want Americans to buy legal pharmaceutical products from Canada where the identical drug is considerably cheaper because the imported drug might not be safe. Those unreliable Canadians. Better to pay top dollar for heparin from the American subsidiary of a Big Pharma multinational, Baxter Healthcare. Except that the active ingredient in Baxter's intravenous heparin came from China. From an uninspected plant. And there was indeed a safety problem:

More than 350 adverse reactions to the drug have been reported to the FDA since the end of 2007, including a dangerous lowering of blood pressure, breathing difficulties and vomiting. Four patients who took the drug died. One of its two manufacturers, Baxter International, stopped selling its multiple-dose vials of heparin earlier this month, and yesterday the FDA advised doctors to prescribe alternatives.

Millions of people each year are given the drug during dialysis or to prevent complications from surgery, but the FDA has never checked the Chinese plant where the active ingredient is made. The agency and Baxter are investigating whether anomalies in the ingredients from China could have caused the dangerous reactions in some patients. (Washington Post)

In fairness to the FDA, they thought they'd inspected the plant:

The American market for the generic drug heparin is shared by Baxter and APP Pharmaceuticals. Baxter gets its product from Scientific Protein Laboratories, a Wisconsin-based company that finishes the drug both in the United States and in China, according to Baxter spokeswoman Erin Gardiner. Baxter sells 35 million vials of heparin a year, she said.

The active ingredient used by Baxter and APP is derived from an enzyme found in pig intestines and is made solely in China. But the reported problems have involved only Baxter's version of the drug, which uses an active ingredient from a manufacturing plant started by the Wisconsin firm called Changzhou SPL, west of Shanghai. It was opened in 2004.

According to the FDA, that plant has not been inspected by Chinese drug regulators, who sometimes do not visit facilities manufacturing for foreign markets. Baxter has said that it had sent its own representatives there to ensure proper manufacturing procedures were being followed six months ago.

Gardiner said that the company has detected slight variations between different lots coming from China.

When the application from the Changzhou firm was activated, Famulare said, it was mistaken for another Chinese firm that made a different drug. The FDA accepts previous positive inspections as sufficient proof that a company is doing a good job, and it can approve new drugs or drug ingredients based on that record.

An honest mistake, perhaps. But a potentially deadly one.

Looking in the wrong places, looking the other way, looking to help your friends. The Bush administration.

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The FDA accepts previous positive inspections as sufficient proof that a company is doing a good job, and it can approve new drugs or drug ingredients based on that record.

Wow! So does this mean that if I get a call from the IRS, I can tell them, "I passed my last audit with flying colors, so you're done here. Piss off."

In truth, I suspect that if I were a prominent political contributor, that it would work pretty much like that in actual fact. I doubt that I would even get the call from them in the first place.

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As I mentioned over at Corpus Callosum, I should think that it would be fairly easy for the FDA to issue "establishment numbers," like those used by USDA, and require that all products be labeled with the establishment number(s) where the active ingredients were produced. This would also help distinguish when more than one plant is operated by the same company. No more name confusion, and no ingredients from unnumbered establishments.

The Bush Administration? How long that FDA policy has been in place?

By pauls lane (not verified) on 20 Feb 2008 #permalink

Revere, you make some very fair points in this post. However, I think it's also fair to note that as of yet, there is no actual data to suggest the Chinese plant is really to blame for these problems.

Even if the plant is to blame, we should be careful not to draw the wrong lesson. IIRC, there were some significant drug quality issues not long ago involving plants in Puerto Rico, where the US has decidedly more regulatory authority than either China or Canada.

I'm not attempting to defend Baxter, SPL, the Chinese plant, or the FDA. I just want to avoid anyone thinking such problems are exclusive to off-shore manufacturing.

qetzal: I think you misunderstood my points. They were two: (i) the hypocrisy of the FDA position on the alleged danger of imported drugs (basically the same point you are making); (ii) the incompetence of the Bush FDA. it is not about offshore manufacturing. That is the FDA line about imported drugs (many of which are actually made in the US, whereas US drugs like Baxter may be made elsewhere).

I suppose you think the FDA will magically become more competent under the next administration?

Government agencies haven't worked for ages. Bush isn't responsible for making the government as a whole suck, and getting rid of him won't make everything better.

By Caledonian (not verified) on 21 Feb 2008 #permalink

Caledonian: That is too sweeping. Many government agencies work well or at least well enough to accomplish their needed purpose. Some administrations are better than others just as some businesses are better than others in management. Big corporations are generally very badly managed, too, but well enough managed to make a profit. When Bush leaves many things will get better but many problems will remain. When the company performs badly, you replace the CEO. The FDA was more competent under other administrations (including Republican ones).

The FDA was more competent under other administrations (including Republican ones).

*thinks back to the confirmation that pharmaceutical companies had been reporting only the positive results of their self-testing*

No, I don't think it was. I think information about its long-term incompetence has been coming out recently, and you are acting as though the incompetence were also limited to recent times.

It's the same thing that makes people blame an administration for the state of the economy when it's the actions of the replaced, previous administration that were the determining factors.

By Caledonian (not verified) on 21 Feb 2008 #permalink

revere, depends on who replaces Bush as to whether 'many things' will get better. 'Many things' might become worse. Some things might remain the same. We just don't know do we? Oh yeah, right, you are a scientist so you know, don't you?

By pauls lane (not verified) on 21 Feb 2008 #permalink

revere,

I understood your points. However, in making them, I think you gave the impression that the heparin problem is very likely related to the Chinese manufacturer. AFAIK, there's no evidence of that.

Of course, maybe it's just me that got that impression. If so, my apologies.

As for the FDA's arguments against (re-)importation, I think they're slightly different than what you suggest. It's not about off-shore manufacture per se. It's about control and oversight of the whole chain: from manufacturer to distributor(s) to pharmacist to patient. Nominally, if the drug is destined for sale in the US, FDA has jurisdiction at every step. (Whether they fulfill their responsibilities adequately at each step is another matter.)

However, if the drug is (re-)imported from another jurisdiction, FDA would have no legal authority to oversee or regulate any of the steps prior to entry in the US. Thus, they contend they could not ensure that US consumers are protected from adulterated drugs.

That is more their argument, to my understanding.

Nonetheless, I agree that in practice, drugs imported from Canada would be no less safe than the same drugs produced for the US. I also agree that the FDA's argument against (re-)importation is almost certainly a red herring.

qetzal: No, I think you read me right. I was implying the problem is with the Chinese plant. But the US has no legal jurisdiction over that plant (and in fact had mistaken it for a different one). IMO, their Canada claims are worse than disingenuous. They are hypocritical and designed to protect Big Pharma, purely and simply.

Depends on what you mean by 'legal jurisdiction' doesn't it? FDA can't tell the plant how to run or sanction any of the owners. But they can demand the right to inspect the plant and the process. If the plant doesn't agree, or if the plant doesn't meet GMPs, FDA can prohibit use of their products in US drugs.

I agree with you on FDA's motives regarding re-importation.

The FDA is in serious need of a complete overhaul, starting with their priorities. They need to start worrying less about protecting their profits, and more about the safety of the people the organization was created to protect. The only reason importation of drugs from Canada is not allowed is to protect the profits of big pharma, and allow big pharma to keep their monopoly on the American drug market. Consumers are getting hurt physically and financially from the FDA lack of focus.