According to a post on NOTUS (here), FDA Commissioner Marty Makary, M.D. says that he has the “Agency ‘Exempted’ from possible shutdown RIFs.” Well, after the hit that FDA staff took over the last eight months, this should be good news for current FDAers. (That is, if you can accept and believe what you read.) During my time at the FDA, I was subject to many evenings of waiting up to the last minute to see whether a shutdown was going to keep me from going to work the next day. But there was no time off for me no matter what as I was always deemed one of the essential employees who had to come into work no matter what.
If people are nervous at the FDA, it is a possible explanation for the low number of ANDA approvals towards the end of September. This is in contrast to the flurry of NDA and BLA approvals that typically occur around the close of the fiscal year. There are likely still some application approvals that haven’t been posted yet, and there is still tomorrow before FY 2025 bids us farewell. Things for FDA employees at this moment are not so rosy; in addition to the usual worries about their paying bills and buying groceries are worries about the potential impact to their careers while Congress figures out how to pay its own bills. FDA folks are like the rest of us and the added stress of a possible shutdown can be not only a hit on morale but also on productivity.
So, let’s see what happens, if anything, as the minutes tick away. Will Congress strike a deal to keep the government open at the last minute? Will the Commissioner’s word strike true or will this morph into another runaway DOGE-like massacre? We don’t have long to wait to see how things will play out.
