Reply to discrepancies in drug approvals: A global dilemma

Abstract

In response to our article,1 Wilson et al have highlighted some compelling points. International variability in regulatory drug approval timelines is a global issue, exemplified by the 2-year difference in the regulatory approval dates for crizotinib between the US Food and Drug Administration (FDA) and Australia. Our study found a median 3-month difference in the time required from submission to drug approval by Health Canada (HC) compared with the FDA (9 months vs 12 months; P<.0006), and incorporated differences in submission times (Fig. 1). Submission to the FDA occurred before that to the HC for 87% of new oncology drug indications. The median time from FDA submission to HC submission was 3.7 months. Regulatory review time was approximately 4 months longer for HC compared with the FDA, regardless of the timing of the submission (Table 1). Therefore, delays in approval between the FDA and HC include discrepancies in both submission dates and the length of regulatory review time. Oncology drug length of time in review by the US Food and Drug Administration (FDA) versus Health Canada (HC). We concur with Wilson et al that streamlining the drug approval process by centralizing drug submission across multiple regulatory agencies is an ideal starting point in alleviating delays in drug approval. This mechanism could potentially be empowered to add international consistency to drug approval indications. Hopefully, the cost of a centralized submission would be made reasonable for smaller drug companies. In the interim, encouraging larger drug companies to submit simultaneously to multiple regulatory agencies and decreasing regulatory review times are potential ways to accelerate access to new oncology therapies for our patients. No specific funding was disclosed. The authors made no disclosures. Doreen A. Ezeife, MD Department of Medicine University of Calgary Calgary, Alberta, Canada Tony H. Truong, MD Section of Pediatric Oncology Department of Oncology University of Calgary Calgary, Alberta, Canada Patricia A. Tang, MD Department of Oncology Tom Baker Cancer Centre Calgary, Alberta, Canada