FDA forms 'SWAT team' to tackle orphan drug backlog

The Food and Drug Administration on Thursday shared a strategic plan to completely eliminate the agency's backlog of orphan drug designation requests.

The plan comes a week after FDA Commissioner Scott Gottlieb, MD, committed to eliminating the backlog within 90 days. The agency has about 200 orphan drug requests pending review.

The FDA will develop a "backlog SWAT team" of senior reviewers who will solely focus on reviewing the backlogged request forms, starting with the oldest requests first. The agency will also use a more streamlined designation review template to improve the consistency and efficiency of the review process.

To ensure all future orphan drug resignation requests are reviewed within 90 days, the agency will:

  • Reorganize reviewers to maximize expertise and improve workload efficiencies

  •  Better leverage expertise across the FDA's medical product centers

  • Establish an orphan products council, which will address scientific and regulatory issues to ensure the agency is consistently regulating and reviewing orphan drug products

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