A Bit of Irony From the FDA

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Oh, irony of ironies.

For the past several years, the FDA has been fighting attempts by patients -- as well as by local and state governments -- to import prescription drugs from cheaper international locales like Canada. But, as was revealed this week and last, apparently the FDA hasn't been doing such a good job of monitoring the compounds that receive its own stamp of approval.

As was first reported in January, some batches of a widely used anticoagulant blood-thinner, heparin (manufactured by Baxter (NYSE: BAX)), may have been contaminated or incorrectly produced. This was discovered after the drug was recently linked to a significantly higher number of adverse events in hundreds of patients.

One of the FDA's roles is to monitor and approve the drug manufacturers, like Baxter, that supply prescription drugs to the U.S. -- regardless of where they are located. The Baxter heparin in question was produced at a manufacturing site in China. The problem for the FDA is that inspections of manufacturing plants outside the U.S.'s jurisdiction are tougher to do, and they are not required before a drug is approved for sale in the States.

As the Chicago Tribune reported on Tuesday, while the FDA thought it had inspected Baxter's Chinese heparin supplier and found it to be safe, it turns out that the agency had mistakenly inspected another Chinese manufacturing plant with a similar name instead.

The problem isn't the drug-manufacturing mishaps; they happen all the time. Many longtime Johnson & Johnson (NYSE: JNJ) investors can recall the 15% drop in that company's shares in 2002 thanks to potential manufacturing issues at a Puerto Rico plant. More recently, Boston Scientific (NYSE: BSX) has been dealing with all the headaches caused by Guidant-related manufacturing defects for some of its top medical devices.

The problem is that the FDA isn't being very consistent with its message.

Just two weeks ago, the FDA sent a letter to the mayor of Duluth, Minn., denouncing the city's plan to help city workers and retirees take part in a program that would lower prescription-drug costs. The program would import less-expensive drugs from government-licensed pharmacies inside Canada, Australia, and the United Kingdom. The FDA stated that it was "very concerned" about the Duluth plan and that "drugs obtained from foreign sources that are represented as U.S. approved prescription drugs are of unknown origin and quality."

Regardless of where you fall on the political issue of drug importation, surely it's not hard to see the irony here. On the one hand, the FDA is warning consumers about importing drugs from foreign sources. But at the same time, drugs that the agency is supposedly ensuring are "safe" are experiencing the same or worse "safety concerns" as the internationally sourced compounds the agency doesn't want consumers to purchase.