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.
The FDA decision, which was announced in a Federal Register notice on Monday, was made in response to a September 2021 ruling by a U.S. appeals court. That ruling found the agency acted “arbitrarily and capriciously” when it approved a particular orphan drug, because the approval contradicted federal law governing such designations.
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