On December 22, 2018, the United States government officially “shut down” after lawmakers were unable to reach agreement regarding budget funding. A shutdown effectively means that funding has lapsed for nine cabinet departments and various other government agencies, including salaries for about 800,000 federal employees.
For many who work in drug development, there were immediate questions about the impact that the shutdown would have on the FDA and on the review of investigational products, including those reviews which were already in process at the time of the shutdown.
FDA Commissioner Scott Gottlieb has been communicating with the public extensively and primarily through his Twitter feed, with some updates also being posted on the FDA website. About 40% of FDA staff have been furloughed (told not to come to work) and the remainder, whose roles are considered essential, are working without pay. In general, FDA has confirmed that they will continue to perform activities related to vital public health and safety issues, including responding to outbreaks of food-borne or medical illnesses, and safety inspection of imported foods and medical devices. FDA can also continue activities that are funded by carryover user fees, since that funding does not come from the federal budget, although those funds will run out soon (1-2 months) and new fees cannot be accepted.
With regard to drug development projects specifically, key messages about what the FDA can and cannot do during the shutdown are:
- New Investigational New Drug (IND) applications will be accepted but will not be considered “received” and will not be reviewed (that is, the 30-day review period will not start and if the submission was received before December 22, the review period clock is on hold). FDA will only review submissions such as IND amendments that are related to emergent safety issues.
- Single-patient INDs for expanded access will continue to be reviewed.
- New Drug Applications (NDAs) and Biologic Licensing Applications (BLAs) that involve payment of a fee in accordance with the Prescription Drug User Fee Act (PDUFA) cannot be accepted. A small subset of submissions that do not include a fee can be accepted (orphan indications, small business fee waivers, etc). This also applies to Generic Drug User Fee Amendments, Biosimilar User Fee Amendments, Medical Device User Fee Amendments, Animal Drug User Fee Amendments, or the Animal Generic Drug User Fee Amendments.
For biopharma sponsors, investigators, patients and families, these limitations are already translating into real impacts on development programs.
On CNN on January 8, 2019, Anderson Cooper interviewed Sarah Doerr, the mother of a child with a rare neurological disease who is waiting for a clinical trial that was scheduled to start in early 2019 pending regulatory approvals. According to Ms. Doerr, the study investigators say that their emails to FDA are met with automated replies that their contacts have been furloughed, and there is now no clear timeline for the study start. When the interview aired, Scott Gottlieb immediately posted a tweet asking CNN to help him contact Ms. Doerr, saying “…saying “…Nobody should be unable to access a clinical trial or compassionate use drug owing to the funding lapse. We will help her. Our drug review staff remains at their posts across our centers….”
The biopharma company Aimmune told Stat News that they are unsure of the status of their marketing application for a treatment for peanut allergy. The application was submitted on December 21 and while PDUFA fees should be covering some review activities, it is not clear whether FDA will meet the February 19 date for informing the company whether their application is accepted for review, leaving them in limbo.
At WCG, we are initially seeing impacts on sponsors who have Phase 1 and other pharmacokinetic studies planned, some of which were within the 30-day IND review window at the time of the shutdown.
Sponsors are unsure whether they should proceed with planned screening and dosing dates at the research centers; limited space at the research centers may be booked far in advance, so forgoing the currently scheduled dates may mean that it takes months to get the study rescheduled. At this time, WCG is advising sponsors not to proceed if the 30-day IND review is not completed.
With no indication of a resolution to the shutdown in sight, it is likely that the effects on clinical trials and drug development programs will continue to multiply. We’ll continue to work with our biopharma and researcher colleagues to mitigate the impact of these effects wherever possible.
 FDA 2018 Lapse in Funding Information: https://www.fda.gov/AboutFDA/WorkingatFDA/ucm629100.htm
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