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New Rules on Prescription Drug Preemption–A Conclusion or Two

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As a regulatory agency, the authority of the FDA is limited to the creation of regulations which implement the responsibilities delegated to FDA by Congress. Since Congress did not expressly preempt state law tort claims, FDA has no authority to establish express preemption.

FDA has no authority to interpret the law. The doctrines of conflict preemption are judicially created and judicially determined. FDA, as a regulatory agency, has no authority to determine the legal force and effect of its regulations. FDA is an arm of the Executive Branch of the Government. Under the U. S. Constitution, Congress enacts legislation and may choose to delegate to an administrative agency of the executive branch the authority to establish implementing regulations. The courts retain the authority to interpret the legislation enacted by Congress and the regulations promulgated by federal agenci4es.

The FDA has no authority to interpret the law. This attempt by the FDA to impose federal preemption and to determine the legal impact of its own regulations violates the separation of powers in the United States Constitution. First, it violates the power given to Congress to enact legislation. Second, it violates the power given to the courts to interpret the law.