GAO pokes holes in FDA's or­phan des­ig­na­tion process; Take­da Tra­di­tion­al­ists make one more ap­peal against Shire buy­out ahead of vote

→ In re­sponse to sev­er­al sen­a­tors’ in­quiry, the Gov­ern­ment Ac­count­abil­i­ty Of­fice has tak­en a clos­er look at how the FDA han­dles or­phan drug des­ig­na­tion re­quests, and it does not like what it found. “The Com­mis­sion­er of FDA should en­sure that in­for­ma­tion from or­phan drug des­ig­na­tion ap­pli­ca­tions is con­sis­tent­ly record­ed in [Of­fice of Or­phan Prod­ucts De­vel­op­ment] re­view tem­plates and eval­u­at­ed by OOPD re­view­ers when mak­ing an or­phan des­ig­na­tion de­ci­sion,” GAO rec­om­mend­ed. While the re­port does not di­rect­ly ad­dress the abus­es of in­cen­tives to ob­tain the des­ig­na­tion for a drug that ac­tu­al­ly reach­es a larg­er, non-or­phan pop­u­la­tion, the HHS pledged to fol­low the rec­om­men­da­tions in im­prov­ing train­ing for re­view­ers.

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