Happy New Year. On a personal note, I have been on a hiatus or shutdown myself to take time while undertaking a move. With that behind me, I am back at it and will be posting again with intermittent content and Weekly Roundups. And while I’m back, the government is not, having experienced a shut down just before the Christmas holiday. FDA has issued a statement on how the partial government shut down would be affecting the agency. In addition, the agency posted a Q&A for employees. The description of activities is not dissimilar to those outlined during the government shutdown of October 2013.
The statement provides an outline of activities that will continue, but there remains some vagueness about what functions will continue during what is referred to as the “lapse period”. The following are areas mentioned specifically:
- Vital activities” to the extent permitted by the law, critical to ensuing public health and safety – however what exactly constitutes vital and what the law permits are not entirely clear.
- Maintaining core functions to handle and respond to emergencies – such as monitoring for and quickly responding to outbreaks related to food borne illness and the flu, supporting high-risk food and medical product recalls when products endanger consumers and patients – presumably this means that the core capabilities will continue to function, however, efforts such as recalls require coordinated communications efforts from the agency and it is not clear if this component is available from the statement.
- Pursuing civil investigations when we believe public health is imminently at risk and pursuing criminal investigations, screening the food and medical products that are imported and addressing other critical public health issues and surveillance for significant safety concerns with medical products continues – This sounds like it covers a lot of ground but turns somewhat on how terms like “critical public health issues” are interpreted
- Support of activities funded by carryover user fee balances – It is somewhat uncertain as to what the term “support” means in this case. For example, advisory committee meetings to consider new drug applications would presumably be a user fee activity. An examination of the FDA advisory committee calendar during the shutdown of 2013 shows that meetings considering new products did take place. However, meetings that were not involving new product considerations were postponed. FDA has an advisory committee meeting on January 11 to consider an sNDA. See Dr. Gottlieb’s tweets noted below for more information in this regard.
Noted FDA activity and inactivity since the shutdown:
- No new press releases issued, no FDA Voice Blog postings and remarkably, no Statements from the Commissioner
- Federal Register notices from FDA have continued to be published, though at a diminishing rate and publication might represent material already in the pipeline
- No new warning letters issued out of any office
- Updates and clarification are being provided by some key personnel on Twitter. While some have only tweeted excerpts from the official statement, Dr. Gottlieb has been using Twitter to provide clarification on finer points on his Twitter feed.
- Some of Dr. Gottlieb’s pertinent tweets:
- From December 28 – We have questions re: drug review work that’s not user fee funded and won’t continue during shutdown. CBER will pause non-emergency work on whole blood, blood components for transfusion, allergenic extracts and HCT/Ps regulated solely under sec. 361 of the PHSA.
- For our Center for Drug Evaluation and Research this also includes pausing all OTC monograph drug activities. Only emergency work related to these products will continue.
- The 30-day review clock for any pending, non-emergency IND for a medical product that is not covered by a user fee program will be suspended during the lapse period. The clock will resume when the lapse period is over.
- However, new emergency INDs and IND amendments that relate tot he safety of individuals who are participating in clinical trials will continue to be reviewed during the government shutdown, even for products that are not covered by a user fee program.
- Many asked if FDA can accept new medical product applications during the shutdown. The FDA can’t collect FY 2019 user fee payments during the shutdown, which means we can’t accept new application for products under user fee programs: PDUFA, GDUFA, BsUFA, MDUFA, ADUFA, AGDUFA.
- FDA retains limited carryover balances for 21st Century Cures and opioids funding. These balances will only be spent on activities for which the funds are authorized. FDA carryover user-fee funds also allow the agency to continue work on existing user-fee related applications. (emphasis added by me)
Will endeavor to keep you posted on new developments. Happy New Year to all.