FDA Modernization Act 3.0

This bill is a legitimate exercise of Congress's power under the Commerce Clause and the Necessary and Proper Clause to regulate the approval of new drugs and to direct the FDA in implementing statutory provisions. Requiring an interim final rule that takes immediate effect is a permissible legislative instruction; Congress may prescribe the form of agency action without violating separation of powers. The delegation to the FDA is limited and specific, providing an intelligible principle for rulemaking, and the one-year deadline is a reasonable time frame. The bill does not encroach upon the P…

The FDA Modernization Act 3.0 operates within the enumerated powers of Congress under the Commerce Clause to regulate the introduction of new drugs in interstate commerce, and the Necessary and Proper Clause empowers Congress to direct the FDA to issue rules to effectuate that regulation. While I hold a strict construction of federal power, the oversight of drug safety and efficacy has been consistently understood as a federal matter, and this bill merely updates the methods for assessing such safety and efficacy. I do not find that it violates the Tenth Amendment, as it does not commandeer st…

This bill is a valid exercise of Congress's power under the Commerce Clause to regulate interstate commerce in drugs. The directive to the Food and Drug Administration to replace references to animal testing with nonclinical tests in its regulations is a specific legislative instruction that falls within the agency's delegated authority and does not violate the separation of powers; Congress may prescribe the manner in which executive agencies execute the laws. The requirement for an interim final rule to take immediate effect is a procedural choice that Congress may dictate, and it does not i…

This bill is a constitutional exercise of Congress's power to regulate interstate commerce and to make all laws necessary and proper for executing that power. The regulation of new drugs and the procedures for their approval directly affect interstate commerce, as drugs are articles of commerce moving among the states. Congress may direct an executive agency, such as the Food and Drug Administration, to issue rules implementing statutory directives, and the requirement to replace references to animal tests with nonclinical tests is a specific, permissible instruction that does not exceed the l…