Contrast Agents Regain ‘Drug’ Status, But Ophthalmic Products Still Subject To Genus Decision
Legislative rider effectively reverses Genus court ruling, and now US FDA must treat contrast agents, radioactive drugs and OTC monograph drugs as drugs. However, the agency will have to assess case-by-case whether certain ophthalmic products meet the definition of ‘drug’ or ‘device.’
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Orphan Exclusivity, Drug-Device Designation Court Rulings Against FDA Would Be Fixed In User Fee Bill
Draft legislation would undo the Catalyst decision prohibiting FDA from providing separate orphan exclusivity periods for different subpopulations and alter the Genus ruling by requiring FDA to treat contrast agents, radioactive drugs and OTC monograph drugs as drugs.
US FDA gives 12 month grace period for ophthalmic products once regulated as drugs to comply with requirements for combination products and temporarily exempts lower-risk constituents. Guidance specifies changes agency is making in response to Genus Medical v. FDA decision.
Sponsors are receiving information requests and complete response letters as a result of the agency’s transition plan, which was made in response to the Genus v. FDA ruling. The decision's aftershocks could reshape the landscape for a number of products, attorney says.