It’s been a weird week. The “Frankenstorm” also known as Sandy blew through Washington, closing everything from the stalwart federal government to the Metro system. OFW Law weathered the storm pretty well, though the view outside my window of the muddy, debris-filled Potomac is an ever-present reminder that our problems pale in comparison to those just north of us. (FYI: HuffPo maintains a live blog of organizations seeking donations.)
Amidst all this, there is, of course, an election tomorrow.
For many of us, it’s The Waiting Game. During national elections, the conventional wisdom, inside the Beltway at least, is that federal agencies “hold on” to their regulations to avoid stirring up any fresh political issues. Timing is everything and, in this politicized environment, new regulations can fuel arguments that the federal government is either: a) endangering public health and welfare by promulgating regulations; or b) endangering public health and welfare by not promulgating regulations. We expect this push me-pull you in federal regulatory practice. It’s part of the rhythm of the seasons like the Capital Weather Gang dusting off the Snow Potential Index in late autumn.
In the case of FDA, many important initiatives have been dangling far beyond any single election cycle. These include:
- Finalizing rulemaking for many over-the-counter drugs, including sunscreens, oral antiseptics, and external analgesics;
- Failure to implement key provisions of the Food Safety Modernization Act;
- Important guidances on the brief summary and help-seeking/disease-awareness communications in prescription drug promotion; and
Issuing or holding off on new regulation and guidance may be a hard sell in the political world but, in the business world, it’s often a different story. Although businesses are certainly concerned with how a particular regulation or guidance impacts them, regulation at least brings certainty. New requirements can be budgeted for, staffed, and incorporated into sound business planning. Uncertainty isn’t good for business. Whatever the outcome of the election, we hope it brings some much-needed clarity and resolution to stalled initiatives.