Congress has cleared the FDA to reorganize its Office of New Drugs (OND). The FDA plans to increase the number of clinical offices and divisions and group them by therapeutic area, enabling it to assign cross-functional teams to new drug applications (NDAs) at the start of the review process.
Janet Woodcock, the director of the Center for Drug Evaluation and Research at the FDA, first floated the planned changes last year. The plan has undergone some tweaks since then, but the broad focus on reorganizing the more than 1,000 people who work at the OND into cross-disciplinary teams that can handle NDAs without routinely needing to enlist specialist consultants remains.
The final plan calls for the OND to increase its number of clinical offices from six to eight. The eight clinical offices will each cover a different therapeutic area such as infectious diseases, neuroscience and oncological diseases.
Each clinical office will sit above two to six clinical and pharmacology/toxicology divisions in the FDA’s new organizational structure. The number of clinical offices will increase from 19 to 27. The plan is to add another six divisions focused on pharmacology/toxicology.
The FDA thinks the expansion will result in divisions with “clearer and more focused areas of expertise.” For example, the Office of Infectious Diseases will feature three divisions: one focused on anti-infectives, another covering antivirals and a third designed to address pharmacology/toxicology issues related to infectious disease drugs.
To prepare for the changes, the FDA is performing risk assessments and taking actions intended to cut the likelihood of disruption. The FDA will not change the review teams for applications currently under assessment. However, the division and signatory responsible for a filing may changes. The FDA will notify applicants if they are affected by such a change.
The reorganization will have knock-on effects at the Office of Translational Sciences (OTS) and Office of Pharmaceutical Quality (OPQ). The changes planned at OTS are intended to align the office to the clinical structure at the OND. In reorganizing the OPQ, the FDA plans to create a new office and seven new divisions.