New and Improved Approach to FDA Approval

The United States Food and Drug Administration (FDA) is taking steps to revise its drug development policies and processes. At a meeting held on November 7, 2019, the FDA met to discuss changes to the organization of its Office of New Drugs (OND). The goal was to develop actionable policy suggestions that would help improve the drug development process while maintaining current standards for assessing new treatments. One major change highlighted at the meeting was the restructuring of the OND, increasing the number of OND offices to 7 and the number of clinical review divisions to 27. This allows for development of review divisions that focus on common therapeutic challenges and clinical trial structures rather than specific disease states. The ultimate goal of this restructuring is to improve the overall expertise of OND divisions, so that they provide advice and guidance regarding the drug development process and are able to implement innovative clinical trial designs. This meeting signals a new era in drug development at the FDA, with a focus on improving expertise across disease areas and on partnering with researchers early in the drug development process to develop a faster and more effective drug approval process.

High Altitude: These changes have major implications for stakeholders involved in drug development. The FDA has worked to improve the drug approval process by increasing the number of accelerated approvals that are based on phase I and II data and streamlining the review process for key therapies, including orphan drugs and breakthrough therapies; it also has incorporated surrogate endpoints in its approval decisions. Despite this, the FDA approval process can be a major hurdle for innovators developing desperately needed treatments. With this reorganization, the FDA is acknowledging the need to improve the approval process and developing pathways to partner with drug developers from early stages in order to improve the quality of novel treatments and the speed with which they are approved.

Ground Level: While this change has little direct impact on community oncologists, it signals a new era in drug development that will influence the treatment of patients on every level. Increasing the speed of new drug approvals means that better treatments may be available sooner, with less lag time between publication of novel data and availability of new treatment options. Community oncologists need to be aware of these changes to the FDA approval process, as the emerging treatments will have a major impact on their clinical practice.