FDA Reorganization Highlights New Realities for the Industry
[Thursday, October 3, 2019]

For the last two years, FDA’s Center for Drugs (CDER) is being reorganized to address the complexity of the products it regulates. These reorganization, termed “modernization”, has been presented by FDA as internal changes that will not affect ongoing and upcoming reviews of applications but there are several practical and logistical aspects of the move that the industry must plan for. First, due to the reorganization, the review divisions, and the associated senior officials have changed. Although, FDA has said that the reviewers assigned to a given application will not be changed unless the applications are at an early stage of review, the supervisors would likely change. Ideally, such changes in reviewers should not impact the ultimate fate of a given application but sponsors must be cautious for any changes in leadership on the overall review. At the minimum the titles of reviewers and the associated MAPPs are being revised, requiring the affected sponsors to review any potential impact on ongoing reviews.  Second, due to the new offices, the sponsor must identify the new divisions that would be assigned to lead the review of their applications. New divisions with new leaders could change the perspectives and expectations of the reviewers. One of the stated goals of the reorganization is “integrated review” of applications which in layman’s words means higher ongoing reviews by dedicated reviewers which could mean higher data expectations from FDA teams. Third, new offices with focused goals have been created which could mean deeper dive into the data by FDA reviewers. For example, six new Pharm-Tox offices have been created indicating higher importance for these data in the applications. Adding more reviewers and giving more authority to certain sections of the review indicates changes in data expectations. Sponsors should be prepared for that.  Lastly, all administrative changes, no matter the intensions, create additional work for the reviewers and sponsors alike. This includes re-educating sponsor’s regulatory teams about FDA’s organizational structure, the new internal processes, and any changes to the timelines, stakeholders and expectations. It is prudent for the industry to review the new organization and adjust to the perceived and real changes that would affect its immediate and long-term interactions with the FDA. The FDA is doing its job of announcing the changes as they happen, and there are more to come in the next year; the sponsors should do their job of listening and adjusting appropriately.