FDA Delays and Workforce Challenges Impact Drug Approvals

The pharmaceutical industry is facing significant challenges as the U.S. Food and Drug Administration (FDA) grapples with a heavy workload and limited resources, leading to delays in drug approval decisions. Recent developments highlight the ongoing impact of FDA restructuring and layoffs on the drug review process.

KalVista's Angioedema Drug Approval Delayed

KalVista Pharmaceuticals, a Cambridge, Mass.-based biotech company, has announced a delay in the FDA's decision on its oral plasma kallikrein inhibitor, sebetralstat, for hereditary angioedema (HAE). The FDA informed KalVista that the decision, originally expected on June 17, could be postponed by up to four weeks due to the agency's "heavy workload and limited resources."

KalVista CEO Ben Palleiko expressed disappointment but remained optimistic, stating, "We are disappointed by this delay, most importantly because we know how much people living with HAE are looking forward to an oral on-demand option to treat their HAE attacks. At the same time, we remain confident in the near-term approval of sebetralstat."

The FDA has not requested additional data or raised concerns about sebetralstat's safety, efficacy, or approvability, according to KalVista.

FDA Restructuring and Its Impact on the Industry

The delay in KalVista's drug approval decision is part of a broader trend affecting the pharmaceutical industry. The FDA has been undergoing significant changes, including layoffs and restructuring, which have led to an increase in delayed decisions for various biotechnology companies.

In March, Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced 10,000 layoffs across federal health agencies, including 3,500 full-time FDA employees. Although 2,000 of these layoffs were later retracted due to an error, the impact on the FDA's operations has been substantial.

Key leadership departures, such as former FDA Chief Medical Officer Hilary Marston, M.D., and former Center for Biologics Evaluation and Research director Peter Marks, M.D., Ph.D., have further complicated the situation.

Industry Concerns and Response

The pharmaceutical and biotechnology sectors have expressed growing concern over the FDA's capacity to review and approve new drugs in a timely manner. In April, hundreds of biotech stakeholders submitted a letter highlighting their concerns and providing examples of companies allegedly impacted by the changes at the agency.

While the HHS initially stated that the FDA workforce reduction would not affect drug, medical device, or food reviewers, recent events suggest otherwise. Companies such as Daré Bioscience and Biohaven have also faced delays in their regulatory processes, with the FDA citing similar reasons of workload and resource constraints.

As the industry continues to navigate these challenges, companies are working closely with the FDA to support the completion of ongoing reviews and maintain progress in bringing new treatments to patients.