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Pharmaceuticals / Regulatory Affairs / Commercial Operations

GAO to Investigate the FDA’s Approval Process for Orphan Drugs

March 29, 2017
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The Government and Accountability Office has agreed to grant a Senate request to conduct an investigation into the FDA’s handling of orphan drugs approvals.

The lawmakers want the GAO to provide a comprehensive list of orphan drugs approved since 1983 — when the Orphan Drug Act was enacted — and a list drug candidates seeking the orphan drug designation over the past year. The GAO should also provide recommendations for regulatory or legislative changes to preserve the intent of the Orphan Drug Act as well, the lawmakers said.

Earlier this month, Sens. Chuck Grassley (R-Iowa), Tom Cotton (R-Ark.) and Orrin Hatch (R-Utah) asked the GAO to evaluate whether the FDA resources have kept up with the demand for orphan drug designations, and whether the FDA’s evaluation process for orphan drugs is consistent across reviews. The investigation won’t be started until the end of 2017.

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