As reports surface detailing the extent of Robert F. Kennedy Jr.’s layoffs at the Department of Health and Human Services, FDA officials are sounding the alarm about their ability to review applications for new drugs moving forward.
The 3,500 job cuts recently announced at the FDA, some of which went into effect Tuesday, have already claimed staff essential to the drug review process, Reuters reported Friday, citing both current and former sources at the regulator.
Aside from the ousting of top scientists overseeing areas like vaccines, medical devices and veterinary medicine, RFK Jr.’s purge has also impacted staff who manage records, like new product applications, at the FDA division overseeing biopharma products, among others, according to Reuters.
While employees who directly review new products were spared—which also seems to be the case for inspectional staff—four unnamed sources told the news outlet that they’re aware of reviewers seeking new jobs following major disruptions at the agency this year.
In turn, fears are growing that the FDA might not have enough reviewers to take part in meetings already on the agency’s calendar.
The issue could be especially pronounced for drugs with novel mechanisms of action, those which use new approaches like artificial intelligence in their development and medicines for ultrarare diseases, former FDA commissioner Mark McClellan, M.D., told Reuters.
"I'm not sure all these reductions are going to stick because of those direct impacts that I don't think were intended," he said.
On Thursday, RFK Jr. admitted to ABC News that the mass firings had hit “[p]ersonnel that should not have been cut,” adding that HSS' intentions to reinstate those roles was “always the plan.”
Backsliding drug review and approval timelines would likely deal a major blow to the credibility of FDA’s user fee collection program, which was introduced via the Prescription Drug User Fee Act (PDUFA) in 1992.
Under the program, the FDA is able to collect fees from companies submitting applications for drugs and other products for review, providing the agency with resources to efficiently carry out its assessments. The setup also helps drugmakers hold the FDA accountable to a timely review process.
Meanwhile, many of the FDA’s staff involved in user fee negotiations were among those hit by RFK Jr.’s wave of cuts, Politico’s AgencyIQ said in a report Thursday. The FDA and the industry need to agree on new user fees before drug reviews can begin.
Compounding the issue, significant reductions in the FDA’s appropriated budget through layoffs put the regulator in danger of violating statutory triggers that are essential to the program, AgencyIQ said.
The FDA’s user fee programs each contain a statutory trigger mechanism designed to make sure the FDA does not fall below historic funding levels and isn’t tempted to use industry fees to replace Congressional funding, AgencyIQ explained. If those triggers are surpassed, the FDA wouldn’t be able to collect new fees and would have to refund existing fees that it has already collected, the regulatory intelligence service said.
User fee programs make up a little less than half of the FDA’s overall funding, according to AgencyIQ.
Should the FDA violate those statutory triggers, the move could “effectively collapse” the agency’s user fee programs before the year is out, the Politico affiliate warned. That would cause major disruptions to the industry, because the programs are fundamental to the FDA’s operations.
Still, the biopharma industry may have “more wiggle room” on the issue than first expected, analysts at Leerink Partners wrote in a Friday note responding to AgencyIQ’s concerns.
Notably, Congress could roll out a statutory delay if appropriated funding drops below the trigger point, which would give the industry some extra time to comply, the analysts pointed out.
That said, recent cuts at the FDA will likely hinder agency efforts to recruit new staff while RFK Jr.’s criticism of industry ties to the FDA could make it more difficult for drugmakers to renegotiate user fee programs, the Leerink team cautioned.
Taking a broader look at the situation, HHS could enact the same volume of cuts at the FDA and still have a workforce able to “competently carry out a portion of the agency’s vast responsibilities,” Steven Grossman wrote in a column for FDA Matters on Wednesday.
Problem is, if those are reductions in force are “random and arbitrary,” which Grossman said “seems to be the case,” then it’s unlikely the move took into account which roles were essential to the FDA’s operations.
Grossman, who currently serves as the President of HPS Group, founded and served as executive director on the Alliance for a Stronger FDA and also created the FDA Matters website.
The issue isn’t purely hypothetical, either.
While the particulars aren’t entirely certain, the FDA this week missed its decision deadline to weigh in on a full, traditional approval of Novavax’s protein-based COVID-19 vaccine.
The decision would have marked the first for a vaccine following the ousting of top FDA biologics official Peter Marks, M.D., Ph.D., last week.
The situation will certainly play a part in the credibility of the FDA’s user fee programs if problems like this persist, although certain news outlets, such as The Wall Street Journal and Politico, more directly linked the delay to anti-vaccine sentiment being disseminated from the top down at HHS under Secretary RFK Jr.
Beyond review timelines, concerns are mounting that the mass HHS firings will also take a toll on the FDA’s ability to carry out inspections of drug and food facilities. Prior to the cuts, the FDA was already grappling with a massive backlog of inspections carried over from the COVID-19 pandemic when travel restrictions severely hamstrung those efforts.
The federal government announced the 3,500 FDA layoffs late last month. The staff cuts at the U.S.’ food and drug regulator are part of a wider 10,000-role reduction across the HHS that has also claimed 1,200 workers at the National Institutes of Health.