Due to the internal and external challenges that the Food and Drug Administration (FDA) faces, sponsors of new drug applications are confronted with a host of uncertainties and at times inconsistent policies.

An article published in Clinical Pharmacology and Therapeutics reviews workload input, process factors, application quality and other factors to shed light on the regulatory review process and address drug sponsors' perceptions of disparities and inconsistencies among the review divisions.

The research-based pharmaceutical industry is facing significant challenges, such as an increase in regulatory burden that impede productivity and innovation.

Currently, one in five new drug applications is rejected, stemming from the necessity of review boards to meet strict deadlines, often not allowing for sufficient communication between them and applicants before a decision must be made. Additionally, recent scientific advances have led to an increase in new and highly innovative drugs, which require more resources to review.

Christopher-Paul Milne and Kenneth Kaitin identified several process factors that could contribute to review delays or other negative outcomes. To assess overall agency performance, the authors looked at the relationship between workload and output over time.

Among their findings is the suggestion that if the current proportion for reviewers per division if reflective of staffing levels for the entire study period, this factor could account for a significant amount of variability in performance, which is consistent with the fact that staffing levels are unlikely to be responsive to rapid fluctuations in workload.

Factors that have an impact on regulatory experience in the future include patient centered-drug development, personalised medicine, and staff turnover. The authors argue that the FDA must move beyond the process challenges it currently faces and focus attention and resources to growing content challenges.

The goal is to provide an effective and cost-efficient process for approving medical products while protecting the public health.

Source: Nature