"Let Me Say It Again: No More Government Shutdowns"

The media needs a good story to help keep the attention of readers. Understandably, this often leads to “news” that is premature, speculative, or improbable. In my opinion, that is the case with the current round of hints that a government shutdown is a possibility. I don’t believe it is a serious threat at this point. (Note: Given this view, I am aware of the irony of my using the government shutdown as the lead-in for this week’s column.)So far, “defund Planned Parenthood” is being taken as a serious issue by a number of Members of Congress, some of whom believe that a Continuing Resolution funding the government for FY 16 (even a temporary CR) is a vehicle for forcing a fight. However, government shutdowns are now out-of-fashion, being seen as the blunt and ineffective instrument that they proved to be 2 years ago in the fight over ObamaCare. An important advantage this time: House Speaker Boehner and Senate Majority Leader McConnell can point to the ineffectiveness of the last shutdown, which everyone can remember. Leadership no longer needs to rely on “ancient history,” as reflected in Newt Gingrich saying that Rs shutting down the government in the mid-1990s was a disaster for the party.This is not to say that things couldn’t get tricky. Speaker Boehner could be put in the position of needing dissident Republicans to pass a CR or have to ask the Democrats for votes despite their conviction that budget ceilings need to be higher. Senate Majority Leader McConnell could have his own difficulties, given the opportunities for a handful of Senators to slow down the Senate’s agenda. However, he has been clear: "Let me say it again: no more government shutdowns."If I am wrong and a government shutdown starts to loom large, what happens to FDA? The larger answer is that FDA will have more functioning programs than most federal agencies, but will still be severely hit. Note also that the following is based on the HHS/OMB rules from 2 years ago and might be different in a new shutdown. With that caveat: 55% of FDA’s workforce was still on the job in the early weeks of October, 2013. This is slightly more than 8,000 employees.Of those working: about 75% were supported by user fee programs. They were doing: reviews of medical product applications; programming specified in FDASIA technical agreements, and regulation of tobacco products. Had the shutdown continued long enough, the amount of user fee work would have been diminished (and more employees sent home) because of the requirement that no work could occur on projects requiring new fees. So, for example, no new NDAs could be submitted.Another 25% of employees were supported by exceptions to the shutdown, which were mainly tasks deemed most urgent for safety/property protection issues (e.g., guards continued to work). Note that a narrow definition was applied: patient, consumer, and industry needs were not factors in who was retained. Also, commissioned corps was exempt from the shutdown, although this was interpreted differently in 2013 than it had been previously.In contrast, almost no one at FDA was working on: food inspections/food safety monitoring; inspections of medical products facilities and clinical trial sites; development of regulations and guidance, especially related to new laws; research, laboratories, NCTR, medical innovation.In sum, FDA and its stakeholders have a lot riding on government staying in operation and not being shut down.Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.