Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since los­ing a con­tro­ver­sial court case over or­phan drug ex­clu­siv­i­ty last year, the FDA’s Of­fice of Or­phan Prod­ucts De­vel­op­ment has re­mained en­tire­ly silent on or­phan ex­clu­siv­i­ty for any prod­uct ap­proved since last No­vem­ber, leav­ing many spon­sors in lim­bo on what to ex­pect.

That si­lence means that for more than 70 or­phan-des­ig­nat­ed in­di­ca­tions for more than 60 prod­ucts, OOPD has is­sued no pub­lic de­ter­mi­na­tion on the sev­en-year or­phan ex­clu­siv­i­ty in the Or­ange Book, and no new list­ings of or­phan ex­clu­siv­i­ty ap­pear in OOPD’s search­able data­base, as high­light­ed re­cent­ly by George O’Brien, a part­ner in May­er Brown’s Wash­ing­ton, DC of­fice.

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