On or­phan drug ex­clu­siv­i­ty, FDA de­cides to go its own way af­ter court loss

The FDA on Mon­day of­fered its lat­est per­spec­tive on how it will in­ter­pret the laws gov­ern­ing the sev­en years of or­phan drug ex­clu­siv­i­ty grant­ed to new rare dis­ease drugs, fol­low­ing a con­tro­ver­sial court loss that left many rare dis­ease drug­mak­ers in lim­bo.

The agency ef­fec­tive­ly de­cid­ed to re­turn to its old ways in mak­ing or­phan ex­clu­siv­i­ty de­ter­mi­na­tions, fol­low­ing the Of­fice of Or­phan Prod­ucts De­vel­op­ment’s de­ci­sion to stop mak­ing these de­ter­mi­na­tions since late 2021 due to the court loss.

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