Posts Tagged ‘China’

Troubled times at the FDA

April 24, 2008  |  General  |  1 Comment

The FDA (Food and Drug Administration) has been battered with another serious incident, this one involving bad batches of the drug heparin (a blood thinner) that originated in China. Nearly a hundred people have died and many others experienced serious reactions after receiving heparin which appears to have been deliberately adulterated with a dangerous (and much cheaper) chemical. Until I read about it I had no idea such a large proportion of our drug manufacturing, like our clothes and our children’s toys, has been outsourced, primarily to China. In fact, now over 80% of the medicines you take, or at least the major ingredients in them, come from abroad. How can we be sure those medicines are safe?

As it turns out, we cannot — assuring the safety of these products is nigh impossible. The FDA is charged with inspecting all factories that make drugs. This was at least manageable when these facilities were in the USA, although staffing cutbacks at the FDA have even made this very difficult. In the case of foreign sites, it is unclear where some of these factories even are, and there are four times as many of them as there were 25 years ago. You can read a good discussion of the FDA’s woes here.

What to do? As one knowlegable person has pointed out, playing “kick the FDA” is not the answer. At its current level of funding, the agency will never have enough inspectors to scour the globe inspecting all these facilities. Increasing this surveilance will cost money. Where should that money come from? Drug manufacturers have reaped the financial benefit of outsourcing — I think it is time they either shoulder a major share of insuring the safety of our medicines, or else bring the manufacturing process back to this county where at least it will be easier to monitor. The recent heparin tragedy shows us what can happen if we do not do this.