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April 30, 2008
Chinese Connection Doesn't Look Good for FDA
Back in November, I warned that China could ill afford bad publicity as its API market took its first steps into a full-fledged, finished product pharmaceutical manufacturing industry. If their drugs turned out to be no safer than their toys, the FDA would take a huge hit and this new industry would be set back tremendously. Recently a link surfaced between Baxter's generic Heparin and a Chinese API manufacturer that looks quite bad for China.
And while the Chinese plant has absolutely not been established as the cause of the potentially life-threatening reactions, the fact that we may never know makes the FDA look far worse than Chinese industry, because they're absolutely at fault. The Chinese plant has never been inspected, and now that something has gone horribly wrong somewhere, the FDA plans to show up as soon as possible. In the mean time, you can bet that the manufacturers just brought in an oil tanker full of Clorox and a pressure washer, and are currently spraying every inch of the plant down three times.
While major news outlets will probably be focusing on the Chinese connection, or possibly the FDA's lack of Chinese oversight, I think this points to a larger problem at the FDA today. The organization has lost focus on what's most important to ensure consumer safety. The FDA's budget is smaller than it should be; in fact, its task is simply impossible at any budget level. But since you can't physically inspect every piece of fish sold in the local supermarket, or make sure every customer knows the trial results of the drug they're taking, you should make sure you hit the important parts.
The solutions are already being discussed by those in the industry, with the prodding of Congressional leaders. But it's unacceptable that, while the organization responsible for consumer safety deals with advertising regulations, an uninspected plant in China is making a drug which, even when extracted safely, is derived from pig intestines over a process that takes hours if not days. If it wasn't bad enough, these drugs are then shipped to the US for use in heart surgery or dialysis patients, whose bodies are already critically compromised.
Again, we don't know that the Chinese plant is responsible for the problems. But this goes beyond Chinese drug manufacturing. It remains unacceptable regardless of the questionable Herparin's point of adulteration. I wouldn't expect that plant to go uninspected even if it was US-based. It's a stretch to think anyone would disagree with that - and yet this was not an oversight, this was a routine decision at the FDA.
Regulating advertising is important. But given the FDA's limited budget, I'd prefer to know my prescriptions don't include e.coli, chemical precursors, or three times as much of the API as I'm supposed to be taking. This might be the single most important job the FDA has - beyond advertising, and possibly beyond even approval or rejection based on a drug's efficacy. Its effectiveness isn't very important, after all, if it kills you in the process.
Look for even more changes in FDA budgets and priorities in the coming years, as congressional fury rises due to cases such as this one.
Posted by Jeremy Spivey at April 30, 2008 04:31 PM