FDA Delays Continue as Agency Misses Multiple Approval Deadlines

The U.S. Food and Drug Administration (FDA) has missed several key approval decision deadlines in recent weeks, raising concerns about the agency's ability to maintain its regulatory functions following significant job cuts. The latest delay involves GSK's application to expand the use of its IL-5 blocker Nucala for chronic obstructive pulmonary disease (COPD).
Nucala Approval Delay Adds to Growing List of Missed Deadlines
GSK had anticipated receiving FDA approval for Nucala in COPD on May 7, 2025, but the target date passed without a decision from the regulator. A GSK spokesperson confirmed the delay, stating, "The FDA is actively reviewing our submission for Nucala in COPD and we are working closely with them to help bring this important treatment option to patients as quickly as possible."
This setback follows similar delays for other pharmaceutical companies:
- Novavax's updated COVID-19 vaccine: The FDA missed the April 1 target date for a verdict on the company's protein-based shot.
- Stealth BioTherapeutics' elamipretide: The agency failed to meet its April 29 deadline for a decision on this investigational drug for Barth Syndrome.
Impact of HHS Restructuring on FDA Operations
The recent delays come in the wake of significant restructuring efforts across the Department of Health and Human Services (HHS) under Secretary Robert F. Kennedy Jr. The FDA has lost approximately 3,500 full-time employees to layoffs, with the actual number likely higher due to voluntary exits.
A former director of the FDA's Center for Biologics Evaluation and Research (CBER), believed to be Peter Marks, M.D., Ph.D., warned that the agency is at serious risk of missing drug review timelines over the next year or two. The expert emphasized that while FDA staff remain committed to conducting timely reviews, the recent changes at the agency are just the "tip of the iceberg."
Industry Concerns and Regulatory Implications
The FDA's recent performance has raised questions about its ability to fulfill its obligations under the Prescription Drug User Fee Act (PDUFA). This program, which allows companies to submit fees in exchange for timely reviews, makes up a significant portion of the FDA's budget and helps hold the agency accountable for efficient reviews.
As the pharmaceutical industry continues to navigate these regulatory uncertainties, companies like GSK remain optimistic about eventual approvals. The GSK spokesperson noted, "Based on our latest discussions with the FDA, we continue to expect approval" for Nucala in COPD.
However, the ongoing delays and missed deadlines have the potential to impact drug development timelines, market entry strategies, and ultimately, patient access to new treatments across various therapeutic areas.
References
- FDA Delays Continue as Regulator Misses Review Date for GSK's Nucala
The missed PDUFA adds to a string of delays at the FDA in recent weeks, including at least two other missed target action dates.
- FDA misses another approval decision target date, this time for GSK's Nucala in COPD
GSK had expected to secure an FDA nod for its IL-5 antibody Nucala in chronic obstructive pulmonary disease on Wednesday, but the May 7 deadline has come and gone without a decision from the U.S. regulator. The situation marks the latest in a string of missed deadlines by the FDA following mass job cuts under the Trump administration.
Explore Further
What are the key challenges GSK faces in its clinical trials for Nucala in COPD?
What potential impact do the FDA's staffing issues have on future drug approvals under PDUFA?
What are the primary differentiating factors of Novavax's updated COVID-19 vaccine compared to existing vaccines?
How might recent restructuring at HHS influence FDA's review processes beyond personnel cuts?
What are the major therapeutic competitors to elamipretide for Barth Syndrome currently under FDA evaluation?