Last week, the Office of Management & Budget (OMB) issued a guidance document on President Trump’s “2-for-1 order,” which requires that “for every one new regulation issued, at least two prior regulations [should] be identified for elimination.”
OMB explains that the goal of the directive is to impose no new regulatory costs, meaning it is not the absolute number of regulations that matter as much as it is the costs associated with them. OMB says that “any new incremental costs associated with new regulations shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.” This means – in theory – that if there are no new regulatory costs to offset, then no elimination is required.
In addition, OMB explains that regulations cannot be eliminated unilaterally, but must instead be eliminated in “accordance with the Administrative Procedure Act and other applicable law.” This means – in theory – that the Executive Branch cannot eliminate any regulation that Congress has required by law, or when doing so would be arbitrary or capricious.
OMB also explains that following topics are exempt:
• management and personnel matters;
• national security;
• foreign affairs;
• military matters; and
• “emergencies” and other special circumstances to be defined by OMB.
If the Administration applies its “2-for-1 rule” in the manner described by OMB, then it will affect fewer regulations than originally thought. Rules eligible for elimination will be limited to those rules that are not required by law, are not related to management and personnel, and are not related to national security or foreign affairs.
In theory, this means that none of the regulations that Congress has directed FDA to promulgate — such as the regulations required by the Food, Drugs and Cosmetics Act or PDUFA or the Food Safety Modernization Act — would qualify for elimination. Nor will any of the regulations that pertain to FDA personnel or internal management.