News Brief: FDA’s Reorganization Plan Comes into Focus at PDA/FDA Joint Regulatory Conference

U.S. FDA center directors provided updates during the second plenary session of the 2024 PDA/FDA Joint Regulatory Conference on September 9. A big topic of discussion was the FDA reorganization, which the Agency has been preparing to implement all year.

Under the reorganization, the Office of Regulatory Affairs (ORA), responsible for conducting field inspections of all FDA-regulated facilities, will be renamed the Office of Inspections and Investigations (OII). Current ORA compliance officers will report to the compliance functions within the centers for biologics, drugs, devices, food safety and veterinary medicine. The reorganization takes effect on October 1.

Current ORA Associate Commissioner for Regulatory Affairs Michael Rogers touted the reorganization for the elimination of duplicative effort and streamlining processes. Rogers said the FDA is working right now on the dissemination of new regulatory contact information to all affected regulated industries.

The new OII will focus on inspections, investigations and imports as its core mission. Another key aspect of the reorganization is the creation of the Office of Enterprise Transformation within the Office of the Commissioner to focus on key information technology transformation projects across the FDA.

The Center Office Updates at the PDA/FDA Joint Regulatory Conference is a long-standing, well-attended session. During the questions and answers period, Peter Marks, Director of CBER, was asked about the possibility of eliminating lot-release testing for vaccines, which is outdated with the advent of MRNA vaccines. Marks indicated that scaling back the testing is under consideration, but the FDA needs to tread carefully given vaccine-hesitancy in the  U.S..

On the second day of the conference, the FDA will provide compliance updates in another well-anticipated session.

[This article was corrected on Sept. 11, 2024.]