STAT+: Despite court ruling, FDA will continue with its approach to approving orphan drug exclusivity

The FDA says it will stick with its process for approving orphan drugs. The agency's approach had come under question amid a battle between drugmakers Jacobus and Catalyst.

In an unexpected move, the Food and Drug Administration will continue to apply exclusive marketing rights for so-called orphan drugs under its existing regulations, rather than take a broader approach suggested by a federal court in a highly controversial case involving one such medicine.

Going forward, the agency will continue to grant seven years of marketing exclusivity for specific uses or indications for orphan drugs — the regulatory term for rare disease medicines — instead of allowing a drug company to win more expansive marketing rights, even if the medicine is only approved for some uses for treating a particular disease.

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