Rare-Disease Drugs Get Help From FDA's Dedicated Swat Team
- Agency is trying to expedite review of requests for incentives
- FDA has backlog of about 200 reviews pending, commisioner says
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Incentives for drugmakers to develop treatments for the 7,000 rare diseases in the U.S. have helped spur innovation in the once-neglected field in recent years -- in fact they’ve worked so well the Food and Drug Administration hasn’t been able to keep up.
To clear a backlog of about 200 requests, FDA Commissioner Scott Gottlieb is deploying a swat team focused solely on reviewing applications to get experimental treatments designated as orphan drugs. The designation, which applies to rare diseases affecting fewer than 200,000 people, qualifies drugmakers for incentives such as tax credits for research and monopoly status for seven years.