In 2008, the U.S. Supreme Court will likely decide a key question that has driven FDA pre-emption debates over the past decade: whether ' as plaintiffs' counsel maintain ' warning labels for FDA-approved drugs and medical devices provide only 'minimum standards,' or whether ' as the FDA insists ' they provide a balanced judgment of the FDA, setting both a floor and a ceiling on safety warnings.
Supreme Court to Confront FDA Pre-emption and the Consequences of 'Overwarning'
In 2008, the U.S. Supreme Court will likely decide a key question that has driven FDA pre-emption debates over the past decade: whether ' as plaintiffs' counsel maintain ' warning labels for FDA-approved drugs and medical devices provide only 'minimum standards,' or whether ' as the FDA insists ' they provide a balanced judgment of the FDA, setting both a floor and a ceiling on safety warnings.
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