10:25 AM
Jun 02, 2018
 |  BioCentury  |  Politics, Policy & Law

Getting flatter

How FDA proposes to reorganize OND to streamline drug reviews

Editor's Note: This article was updated on Jun 06, 2018 at 4:37 PM PDT

Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, brought the center’s entire staff of about 5,000 people together in the agency’s Great Room on June 1 for a town hall meeting to roll out a proposed reorganization of the way the agency reviews new drugs. The changes she described to the Office of New Drugs (OND) could make reviews dramatically more efficient and consistent, and enhance the scientific expertise and stature of its scientists and physicians.

Woodcock told her staff that anticipated efficiencies resulting from workflow changes and new technologies will allow them to carve out more time to interact with the world outside FDA’s campus.

OND’s organization would become flatter, with the addition of new disease-focused divisions clustered into offices aligned with those same diseases.

To understand, facilitate and lead the scientific progress that is propelling medical advances, she wants CDER staff to up their engagement with academic researchers, the pharmaceutical industry and regulatory agencies in other countries. She also emphasized the importance of reviewers collaborating with patients, caretakers and their advocates.

For drug sponsors, the most important outcome of the proposed reorganization could be increased opportunities to receive FDA feedback on trial designs and endpoints, as well as increased consistency among review divisions.

The reorganization is subject to congressional approval. FDA expects to submit a proposal to congress in mid-December and could receive final approval in January 2019. The reorganization is unlikely to provoke political controversy.

The change is one of several the agency is trying out that could shave more time off reviews. At the American Society of Clinical Oncology (ASCO) meeting on Saturday, FDA Commissioner Scott Gottlieb unveiled a pilot program at the Oncology Center of Excellence (OCE) in review processes for cancer drug candidates (see “Real-time Reviewers”).

Sidebar: Real-time reviewers

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