The Shutdown Continues: More Qs; More As

Q.  What distinguishes essential personnel who continue to work from other important people and functions that are furloughed?A.  In the more benign context of who has to report to work during a snowstorm, there has always been some humor in who are “essential personnel” and why that is not necessarily the highest ranking or most important individuals at the agency. In a shutdown, the stakes of “who’s in/who’s out” are much higher because the continuation of activities is always conditioned by “as permitted by law.” While there are always exceptions, it may be easiest to view the rule in terms of immediacy. If your absence from work would pose an immediate threat to public health, safety and property, then you are essential in a shutdown. So, safety surveillance experts, product recall teams, emergency inspectors, criminal investigations, etc., are essential, as well as more mundane but important tasks like security guard. As noted, this is an imperfect guideline, but explains most of who is working.Q.  There are news reports (1/11, Washington Post) that OMB is asking agencies to submit lists of government services that are shut down and having a high impact on people.A.  The Administration is trying to limit the impact of the shutdown, since almost all of the disruption is collateral damage, rather than central to the impasse or its resolution. For example, they have found a way to continue SNAP (food stamps) funding through February. This is a front-line program impacting tens of millions of people. If the news story is true, solicitation of government agencies for lists of impacted services may give Dr. Gottlieb additional opportunities to fight for the recall of more FDA employees to carry out the agency’s vital services.Q. If the impasse is resolved -- either by agreement or some exercise of Presidential authority that moots the need for an agreement -- how long would it take for workers to be called back?A: The House has now passed two version of appropriations bills for the shut down agencies: an omnibus one and individual bills. Spending levels are identical to the ones the Senate passed earlier. Unless the agreement requires redrafting with the appropriations bills themselves, restoring government could be accomplished quickly by a Senate vote and a Presidential signature. Depending on circumstances, restoration of government services might not occur that quickly.Q. What are the consequences of Dr. Gottlieb’s announcement that some remaining PDUFA user fee reserves will be used to upgrade post-market surveillance until the shutdown is over?A. FDA’s predictable time frames for evaluating medical  products is a stimulus to investment in innovation and advances the needs of patients waiting for new and improved therapies. Any lapse in that process is consequential and regrettable. Nonetheless, Dr. Gottlieb faces a predicament: he is fully committed to user fees and user fee timelines, but his first obligation is to the immediate public health and safety needs of the American people. We are all hoping the shutdown will be resolved quickly, so that the FDA can again fulfill its broad responsibilities and abandon the triage of its resources caused by the shutdown.Editorial note: The Analysis and Commentary Section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.