What Happens At and After Midnight, Cinderella?

Timing of the Shutdown

• Later this afternoon.  Individual employees will be notified as to their employment status later today in the event of a lapse in appropriations funding.
• Midnight tonight.  Unless Congress acts before 11:59 p.m. this evening, a lapse in FDA’s appropriated funding will commence at midnight tonight.
• Between Saturday and the early morning of December 26. “Christmas Eve day” is a federal holiday this year, meaning most affected FDA employees will not report until next Wednesday. There may be some modest impacts in the interim, but most of those working at FDA this weekend -- and subsequently over the two-day holiday--are likely to be exempt from the furlough anyway.
• Just before New Year’s Day. Republicans will lose some leverage when the new Democrat majority in the House is sworn in on January 3. However, a compromise between Christmas and New Year’s Day appears unlikely.
• January 5-12. It will take a few days before the dynamic of a Democratic House starts to become real. This will also align with the end of 2 weeks of shutdown and pressure for a compromise is likely to be intense.

Who will be working at FDA?

• 59% (10,344) of FDA employees will be retained and 41% (7,053) will be furloughed. An HHS source document can be found here.
• Members of the Commissioned Corps will be working -- roughly 1,000 FDA employees spread throughout the agency.
• Also unaffected would be individuals working in areas where their absence would constitute a threat to public health and safety or property.
  • Emergency inspections would be staffed, but not routine ones.
  • Criminal enforcement work and civil investigations related to imminent threats to human health or life will be staffed.
  • The FDA would be staffed to continue to address existing critical public health challenges, including drug shortages.
• Not working: Most individuals involved in the development of regulations or the conduct of administrative or policy work.
• Distribution will be uneven.
  • Food programs (nearly 5,000 employees of CFSAN and CVM) are likely to be thinly-staffed, apart from emergency inspectors and other front-line employees who are responsible for human and animal health and safety.
  • The Tobacco Center is fully-funded by user fees and presumably 100% will be working.

How does user fee funding impact the situation?  The bulk of those retained will be based on the availability of user fees (about 6,900 employees).  User fee exemption from the shutdown is task driven, not individual person driven. As a result, someone working on user fee tasks can’t work on other tasks just because they are in the office.

• Almost 5,000 are associated with prescription and generic drug user fees
• 900 employees are at the Tobacco Center.
• More than 1,000 are associated with the other user fees.

How much of the drug and device product review programs will continue during a shut-down?  The last number we saw, perhaps a year or two ago, is that about 30% of the drug review process is paid for by appropriations. Therefore, logically, some part of the drug review process will not continue during a shutdown.  The same would be true of devices, except that a larger percentage of the costs are paid from appropriated funds.NDAs/BLAs/PMAs have their own product user fee. Companies that have filed and paid the fee can expect FDA to continue the review, even during a shutdown. Fine print: while reviews continue, there is a risk that agency time frames may slip. Also, while we can think of no specific examples, it is possible that a product review could require some activity or input unavailable in the absence of appropriated resources. Additional insight can be gleaned from 2013 guidance.Based on past shutdown planning, products on which user fees have already been paid (e.g., NDAs) are more likely to be staffed than earlier stage activities. However, we do not know where the precise lines are being drawn and cannot provide assurance than any given activity will be fully continued (or partly continued or not continued) during a shutdown.What happens to food safety?  We know that food safety will be particularly hard-hit, as will routine inspections.  These functions are largely funded by appropriations.  Personnel who routinely respond to important matters -- such as those supporting Food Facility Reregistration -- will most likely not be available. FDA will be staffed to manage outbreaks related to foodborne illness.  FDA will be staffed to manage high-risk recalls.  The FDA will review import entries to determine potential risks to health·Agency Websites.  Most agency websites will not be updated during a shutdown. Portals may close.Does it matter to FDA that most non-FDA components of HHS are already funded?  Most of the rest of HHS (except the Indian Health Service) are funded through either the Labor-H appropriations bill or mandatory funding.  That other parts of HHS are working  does not materially impact FDA.Will the Alliance for a Stronger FDA be Shutdown?  No.  Despite the impending holidays, the Alliance will be available to its members throughout any shutdown. If you have any questions, contact Steven Grossman. Our next planned edition of the Friday Update is on January 4.