The FDA is still holding it together during the longest government shutdown in history but could face big problems if it continues for another month and user fees dry up.
That’s according to two FDA experts cited by analysts at Jefferies, who suggest that in a few weeks reviews could come to a halt, affecting dozens of drug applications and potentially creating a “growing backlog” of delayed programs.
Notable near-term marketing applications that could be impacted if the government impasse isn’t resolved include Sage’s postpartum depression therapy brexanolone, Karyopharm’s selinexor for multiple myeloma and Amag Pharma’s bremelanotide for female sexual arousal disorder, say the analysts.
The FDA still has around a month of funding from prescription drug user fees, and that means submissions filed and paid for ahead of the partial shutdown on Dec. 22 will continue, along with any advisory committee meetings, say the experts. After that, they predict that “many reviews will stop,” according to Jefferies, and the FDA may have to narrow its focus to urgent activities relating to public safety.
“In the worst case scenario, if the shutdown continues and the agency has to halt all review processes and focus only on ‘essential matters,’ then we end up in ‘murky waters’ as we will end up building a queue of submissions,” write the analysts in a research note.
“According to our experts, the agency will have some algorithm of how they go through the queue with drugs/agents with priority review and/or other high need taking priority,” they add, but in this case it is clear companies later in the submission queue would see delays.
For now, the FDA is still in “business as usual” mode when it comes to prescription drugs, with Commissioner Scott Gottlieb pointing to new guidance on labeling for medicines reviewed under its accelerated approval pathway as well as performance criteria for medical devices and pointing to its record-breaking performance last year on novel drug approvals.
Today, #FDA finalized a policy on labeling for drugs approved under accelerated approval, reflecting the more frequent use of this pathway for drugs used in certain clinical settings. https://t.co/xtNGW1wkj0— Scott Gottlieb, M.D. (@SGottliebFDA) January 22, 2019
There are growing concerns that trouble is brewing, however. A letter sent to President Donald Trump, Speaker Nancy Pelosi and other senior lawmakers yesterday by almost 50 organizations representing the medical profession and patients expresses concern about the consequences of the shutdown on access to medicines.
“While we applaud Commissioner Gottlieb, FDA leadership, and ‘essential staff’ for truly heroic work to keep many aspects of its mission functioning, we fear that this continued shutdown not only puts the current health and safety of Americans at risk, but has begun to put future scientific discovery and innovation in jeopardy,” they write.
“We ask that the President and Congress act immediately to bring the FDA back to its full capacity. Americans’ health and patients’ futures are at stake.”
The Senate is due to vote tomorrow on a pair of bills that could end the shutdown if passed. One is a Republican-backed motion that would meet Donald Trump’s demand for funding for the southern border wall in return for concessions on the status of "Dreamers," people brought illegally to the U.S. as children. A second Democrat proposal contains no provision to fund the wall but would fund federal agencies for three weeks.