CDC: U.S. Dodged a Bullet with Heparin
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The Centers for Disease Control and Prevention is receiving praise from several recently published medical journals for successively tracking down the deadly contaminant that had been used in the blood thinner heparin, earlier this year.
The New England Journal of Medicine details how the CDC identified the adulterated product, which found its way around the world, "into at least 21 dialysis facilities and some heart clinics in at least 11 states," (U.S. News and World Report, 12/4/08), prompting Baxter Healthcare to recall the heparin products. Unfortunately, this was only after an abundance of adverse drug reactions and more than 100 deaths occurred.
Since many ingredients found in American drugs come from China or elsewhere around the world, it is important for the Food and Drug Administration to be able to provide the regulatory standard that applies to drug-making facilities in the United States, over in these oversea plants. If the FDA is unable to scrutinize foreign plants and these plants face the bare minimum when it comes to inspection and oversight, the U.S. will likely face an even greater tainted drug problem than the recent heparin scare.
Baxter sold more than 10 million doses of the drug to distributors over a three-month period, and, fortunately, the number of lots contaminated and people harmed was relatively small considering the prolific amount of heparin used throughout the marketplace. But the reason there were only a small number of people affected by the drug has more to do with the effort of the CDC working with local and state public health officials to stop the problem, than it does with the FDA's ability to prevent it.
Frankly, the FDA doesn't have the money, people or resources (information systems) at this time to meet the global challenges of drug regulation, especially when the drug's used in America are not made in America. But the FDA should be adequately armed in all of the former categories. If the heparin panic and recall was a warning to our drug regulatory system, and it's clear that this wasn't the first time a product from China had caused a widespread recall in the U.S., then what other contaminated ingredient could find it's way into our sometimes porous (it only takes one ingredient, one drug, one mistake, etc.) drug manufacturers' and distributors' hands and how efficient would the CDC or FDA be a second time around at discovering and recalling a "heparin-like" drug?
The key: put more resources into preventing the problem and the probability of further contaminated products reaching the United States will diminish over time.