3 FDA decisions that could be delayed if the U.S. defaults on its debt

As lawmakers trudge through debt ceiling negotiations, the possibility that the U.S. will default on its loan obligations in the coming days looms like a dark cloud over Washington. Should government coffers run dry on June 1, as Treasury Secretary Janet Yellen has warned they could, federal workers will go unpaid and agencies like the FDA could see operations come to a screeching halt.

Just last week, FDA Commissioner Robert Califf said that without a bipartisan bill to raise the debt limit by June, the regulator wouldn’t have the money to pay staff and scientific reviewers, potentially delaying upcoming drug approval decisions, advisory committee meetings and regulations.

And with President Joe Biden and House Speaker Kevin McCarthy scrambling to finish negotiations — while haggling over where to cut federal spending in future budget packages — it’s unclear when a deal might be struck, or how long a potential default could last. For patients and pharmaceutical companies depending on the FDA’s actions, a holdup of any length in the decision-making process could be devastating.

Here’s a look at the most noteworthy drug decisions that could be impeded if the U.S. defaults on its debt.

June 8: AstraZeneca and Sanofi’s RSV drug

An FDA advisory committee meeting on Sanofi and AstraZeneca’s monoclonal antibody for the prevention of respiratory syncytial virus (RSV) in newborns and infants slated for early June may be rescheduled if the agency doesn’t have enough funds to pay the group of independent advisers. 

The drug is the latest in a series of RSV candidates put before the regulator, including GSK’s recently approved vaccine for older adults and Pfizer’s vaccine for pregnant people, which could see approval in August. Sanofi and AstaZeneca’s candidate, nirsevimab, is aimed to treat children 2 years and under who are entering their first or second RSV season.

The FDA’s approval decision for the drug was expected by September, roughly four months after the anticipated June ad comm, but a delay could shift the whole timeline back.

June 22: Intercept’s NASH candidate

Intercept Pharmaceuticals’ treatment for a common fatty liver disease called NASH hit a wall in May when the FDA’s gastrointestinal ad comm voted 15-1 against the use of the accelerated approval pathway for the drug. And while the FDA typically follows the advice of independent advisers, it doesn’t have to and now the New Jersey-based company may have to wait longer to see which way the agency goes. 

The drug, called Ocaliva, is already marketed as a treatment for primary biliary cholangitis and it could be the first FDA-approved therapy for NASH. However, the FDA’s advisers noted serious concerns with the drug. The panel voted 12 -2, with two abstentions, that the benefits of Intercept’s candidate didn’t outweigh potential risks, including concerns that it induces liver injury. Advisers argued that more information on the long-term impacts to patient health were needed and cautioned the FDA to wait for results of an ongoing phase 3 trial, which isn’t expected to be completed until 2025.

June 22: Sarepta’s Duchene gene therapy

The FDA last week deferred its much-anticipated decision for Sarepta Therapeutic’s Duchenne muscular dystrophy candidate until mid-June, stating that it needed additional time to complete the review.  However, if the debt default disrupts the agency’s review process, which may include negotiations around the drug’s label and post-marketing requirements for Sarepta, that decision could be even further delayed.

An FDA ad comm panel voted 8-6 backing the accelerated approval of the gene therapy in early May.

And Sarepta said last week that the agency is considering initially approving the drug, SRP-90001, in patients between ages 4 and 5. Year-end results of an ongoing phase 3 trial could support a broader label in the future, the drugmaker added.

If given the go-ahead, the one-time treatment would provide the first potentially curative option to children with the condition, which causes muscles to slowly waste away.