No One’s Interests Would Be Served by a Shutdown

One week out (the CR expires Friday, December 8), it is hard to judge the likelihood of a government shutdown. In similar circumstances in prior years, Congress has usually passed a CR extension. Yet shutdowns have occurred and cannot be characterized as “unthinkable.” Note: The real deadline is late on Sunday, December 10, since the consequences of a shutdown are negligible until government workers are scheduled to report to their offices on Monday.When a shutdown is threatened, OMB sends directives to cabinet departments providing for the “orderly shutdown of government functions” in the absence of funding from either appropriations bills or a CR. While the broad outlines of the OMB directive have been consistent over time, the details can vary, as can each department’s interpretation of the OMB  guidance. The last directives/interpretation from HHS (September 15, 2015 for a possible FY 16 shutdown) are here  and here. Note that no shutdown occurred and that similar documents produced today would not be exactly the same.OMB handles a potential shutdown as a zero-based activity that, with exceptions, focuses on what work is being done, not who is doing it (e.g., some security personnel at White Oak will be working, but many senior scientists and health professionals might not be).  Accordingly, OMB assumes every federal employee will be furloughed unless some specific provision of law, regulation, OMB guidance, or HHS interpretation precludes a furlough occurring. There are two broad categories, although OMB or HHS can add additional exceptions or narrow these existing ones:

• Exceptions “Authorized by Law.” This would include activities: not affected by lapse of appropriations (e.g., Social Security); Presidential appointees (which should include commissioned corps officers working at FDA); and jobs whose continuation is implied by law (e.g., law enforcement).
• Exceptions Based on Safety of Human Life and Protection of Property. This would include activities involving: direct patient care; security of facilities, computer data, clinical information, and confidential materials; and protection of ongoing experiments.

In the past, OMB and HHS asserted that the needs of consumers, patients, and industry were not factored into which activities were continued during a shutdown and which were deferred.FDA’s situation is particularly complex because of its multiple funding sources and several personnel systems. As a result, FDA’s ability to maximize the number of retained employees is particularly sensitive to any changes in the OMB directives and HHS's interpretation and implementation. As a baseline, in the 2015 (for FY 16) guidance, HHS directed FDA to

continue activities related to its user fee funded programs including the activities in the Center for Tobacco Products.

FDA was also directed to

continue select vital activities including maintaining critical consumer protection to handle emergencies, high-risk recalls, civil and criminal investigations, import entry review, and other critical public health issues.

However, HHS also noted that

FDA will be unable to support the majority of its food safety, nutrition, and cosmetics activities.  FDA will also have to cease safety activities such as routine establishment inspections, some compliance and enforcement activities, monitoring of imports, notification programs (e.g., food contact substances, infant formula), and the majority of the laboratory research necessary to inform public health decision-making.

While reiterating that there are certain to be differences this year, we can provide some illustrative numbers from 2013 (actual shutdown) and 2015 (projected shutdown).  In 2013, about 8,000 FDA employees were retained in the early stages of the shutdown (about 55% of the agency workforce) and in 2015, it was projected to be 9,500 retained FDA employees (57% of the workforce). As might be expected, the retained staff were heavily skewed toward user fee-funded activities; food safety activities were the hardest hit.  My recollection is that in 2013, all employees (including retained ones) were directed to immediately return to their base from travel status. No further travel was permitted, even to events held in the DC area where there would have been no cost.The public, as well as stakeholders, have come to rely on FDA -- so even 55% seems shockingly low compared to the daily responsibilities assigned to the agency. However, based on 2013, some agencies may have less than 10% of their staff available in a shutdown ... so, the importance of FDA actually shines through.  However, no one’s interests are served by a shutdown and we are hoping none occurs.Editorial note: The Analysis and Commentary Section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.