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AAJ: FDA Warning To Glaxo Highlights Dangers Of Preemption

April 15, 2008 (Washington, DC) — As reported in the Wall Street Journal, the Food and Drug Administration (FDA) has issued a serious warning to GlaxoSmithKline after discovering the drugmaker did not inform the agency about clinical trials it was conducting on the diabetes drug Avandia between 2001 and 2007.

Avandia has been linked to causing heart attacks and, in November 2007, the FDA ordered Glaxo to add a “black box” warning to its label.

Additionally, a federal appeals panel in Philadelphia ruled yesterday that pharmaceutical companies could receive total immunity if a drug label was approved by the FDA, even if the manufacturer did not provide notice of increased risks to consumers. This case involved another Glaxo drug, Paxil, an antidepressant that has been linked to suicides.

The following is a statement from American Association for Justice Vice President of Strategic Communications Cecelia Prewett:

“This latest FDA warning again proves the agency is unable to protect Americans from dangerous drugs and devices. For years Glaxo has been hiding the results of clinical studies from the understaffed FDA who is only able to issue warning letters after damage has been done. “Because of increasing partiality toward preemption, it is becoming more difficult to hold drug and device makers accountable for patients’ injuries.

“This fall, the U.S. Supreme Court will hear Wyeth v. Levine, which will shed light on the issue of whether federal law preempts state law with respect to drugs. Congress has been clear that it never intended to preempt state law regarding either drugs or devices. Congress should also take the lead to protect consumers in ensuring federal regulatory agencies are following Congressional intent and not preempting state law.”