Chapter 15: the Regulatory Process

Chapter 15: The Regulatory Process

Answers to Select Case Questions

ETHOD OF ECONOMICS 2. The FDA did not have to review the drugs. The Court held there is a presumption of unreviewability of decisions of agencies not to undertake enforcement actions. Like other law enforcement agencies, regulators have substantial discretion to decide what actions to bring. Unless a statute specifies otherwise, the presumption is in favor of the agency's enforcement decision or non-decision.

4. The court held the rule to not be consistent with the statute. While courts give deference to an agency’s interpretation of a statute, when an agency clearly goes too far or not far enough, a rule is stricken. The statute says drivers should know if “a tire” is low on air, not if only one tire is low on air. Therefore, the rule must require air pressure sensors on every tire.