Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in ear­ly 2018 when Scott Got­tlieb led the FDA, there was a mo­ment when the agency seemed poised to re­lease redact­ed com­plete re­sponse let­ters and oth­er pre­vi­ous­ly undis­closed da­ta. But that ini­tia­tive nev­er gained steam.

Now, a grow­ing cho­rus of re­searchers are find­ing that a dearth of pub­lic da­ta on clin­i­cal tri­als and phar­ma­ceu­ti­cals means in­dus­try and the FDA can­not be held ac­count­able, two law pro­fes­sors from Yale and New York Uni­ver­si­ty write in an ar­ti­cle pub­lished Wednes­day in the Cal­i­for­nia Law Re­view.

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