On September 17, 2013, the Office of Management and Budget (OMB) sent out a memo advising federal agencies to begin preparing for a government shutdown. Once again, as in the Spring of 2011, we are faced with the question of what will happen if it occurs – particularly for FDA.
This must be prefaced by saying I have no inside information nor have I spoken with anyone at FDA about what would happen in the event of a shut down of the government should such an event occur on October 1. Nor do I think FDA would be interested in having that discussion. However, given that FDA regulates approximately one-fourth of the U.S. economy, one has to figure that there are consequences to our every day lives.
However, there was plenty said in the Spring of 2011 and there are some historical notes from the 6 day shut down that occurred in 1995. Here is a little bit of what was said then and a few notes from the past of how a shut down affected healthcare in general and FDA in particular.
- According to About.com, for Medicare and Social Security – about 400,000 people were delayed from being enrolled into Medicare and 112,000 social security claims were not processed while 800,000 calls when unanswered;
- According to. Per another posting, this means 640 trials will not be accepting new patients.
- Most of the impact of a shut down on FDA’s day to day operations would seem to be concentrated on the agency’s ability to conduct food and drug inspections – both here and abroad – on food and drugs manufactured here and those to be imported into the U.S.
- Without knowing what staff would remain for emergencies while the rest are furloughed, one has to wonder whether or not alerts would be sent out that warn the public about emerging issues, sometimes serious safety issues, associated with a foodborne illness or food or drug product adulteration or drug adverse event reports.
- If the shut down would last long enough – days or even weeks, holding meetings – and even preparation for meetings – could be affected, including 9 separate Advisory Committee meetings scheduled for October.
- Warning and NOV letters would not be coming out, though none have been posted on the OPDP site for nearly two months.
- Finally, any company with a PDUFA date for a product approval that comes and goes during a shut down should probably not count on that approval happening on time.
Undoubtedly there are many more consequences, but these are a few that are immediately drawn into question. And many are hopeful that a solution will be forthcoming because the drastic consequences of a shut down are too undesirable. But remember – that is what they said about the sequester.