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FDA Plays Both Sides

Drug and device makers have started testing a simple but potentially powerful argument when their customers wind up hurt.

In a nutshell, they say this: It's not our fault. The Food and Drug Administration approved our products and deemed them safe for public use. A blessing from the FDA, which boasts a slew of medical experts, trumps your lawsuit any day.

In a twisted deal, critics claim, the FDA has stacked the deck against the very people it is supposed to protect. Early this year, the agency announced long-awaited labeling changes meant to better explain drugs and their side effects. But before issuing its new guidelines, the agency quietly added a preamble that could give its own stamp of approval more power than state laws allowing consumers to sue drug makers for failing to warn them of possible risks. Judges must now decide whether the rule applies to those cases or not.

Daniel Troy, former chief counsel of the FDA, explained the so-called Preemption Preamble in a recent issue of Legal Times.

"The FDA's bottom-line concern is that 'state-law attempts to impose additional warnings can lead to labeling that does not accurately portray a product's risks, thereby potentially discouraging safe and effective use of approved drugs,'" Troy wrote in the magazine's Oct. 9 issue. "A few courts have refused to defer to the Preemption Preamble and have rejected preemption on a variety of grounds. But few, if any, of those decisions carefully analyze the nature and extent of the FDA's decision-making or the degree of deference due to the FDA's views."

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