A Legal Shield: “The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted.” (New York Times )
A very bad idea for anyone other than Big Pharma, in my opinion. The drug companies are sitting pretty if pro forma approval by an overwhelmed agency that has not effectively regulated in decades is the sole legal standard.
