Editor’s Note: The author correctly highlights in the article below that FDA is required by OMB Circular A-4, Regulatory Analysis, “to analyze options that are not currently legal so as to inform the president and Congress when there are more efficient ways of solving a particular social problem than Congress had envisioned.”
From: Mercatus Center/George Mason University — Public Interest Comments, Docket No: FDA-2011-N-0921
Michael L. Marlow
Introduction
The Regulatory Studies Program of the Mercatus Center at George Mason University is dedicated to advancing knowledge about the effects of regulation on society. As part of its mission, the program conducts careful and independent analyses that employ contemporary economic scholarship to assess rulemaking proposals and their effects on the economic opportunities and the social well-being available to all members of American society.
This comment addresses the efficiency and efficacy of this proposed rule from an economic point of view. Specifically, it examines how the proposed rule may be improved by more closely examining the societal goals the rule intends to achieve and whether this proposed regulation will successfully achieve those goals. In many instances, regulations can be substantially improved by choosing more effective regulatory options or more carefully assessing the actual societal problem.