Securing the aims of regulation

Having an Act and enforcing it effectively are not the same. At first there were disputes about the way in which the Food and Drug Administration might reasonably apply the substantial evidence standard to drug products that had been approved on the basis of previous legislation.

The task that the Food and Drug Administration faced was enormous, because there were no established rules or procedures for implementing the new effectiveness standard, and initial efforts to promulgate rules and regulations were repeatedly challenged in the courts. Only in 1970 did the Food and Drug Administration publish rules that survived challenge in the courts. The basic principles of these rules still apply, although some minor modifications were made in 1985.

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