Everyone is abuzz about what it would mean if there was a government shut down due to the current budget impasse caused by passage of cuts to the current fiscal year expenditures by the U.S. House of Representatives. For the FDA, by the way, those cuts would be over $220 million. Meanwhile, the FDA and its advocates continue to advocate for a raise in the next fiscal year and the Administration has put in a 33% increase for next year to help the agency meet its growing mandate. However, as Rep. John Shimkus replied to FDA’s Jeffrey Shuren’s statement explaining the need for greater funding at a hearing of the House Energy and Commerce Subcommittee on Health on February 17 “You can ask all you want. There’s no more money” according to Reuters coverage of the hearing.
The date for action is March 4, after which if there are no appropriations for the current fiscal year, there will be no money with which to run the government? What would that mean for FDA?
To get some insight, it might be good to look at last time this happened. According to one source, the NIH stopped accepting patients into its clinical trials. According to About.com, the shutdown in 1995 also had the following effects – 400,000 newly eligible Medicare participants were delayed in enrolling; 112,000 social security applications were not processed and 800,000 calls for information went unanswered, to name a few of the many impacts.
What would the impact be on FDA? That, of course, is wholly speculative, but one could assume an impact on the immediate advisory committee meetings for March, of which there are 5 days worth of meetings in the week following the March 4 deadline. One would also have to presume that regulatory inspections may not happen and of course, unless prioritized, other types of inspections of imports, etc. might be affected. If the shutdown went on for any length of time, presumably PDUFA dates would not be met in a timely fashion.
Much of what FDA does is involved in long-term processes, like the development of guidances (or not) and setting up policies such as the regulatory detail for biosimilar approval. But much of it is also on a day-to-day basis whereby interruption may on the one hand, cause some inconvenience to schedules but on the other, could impact the public health – and that is just respecting FDA. In whatever way the political climate may have changed since 1995 when the government shutdown proved politically unpopular, the bottom line is that such a shutdown is still not a good idea.