FDA warns Ac­celeron of pos­si­ble fines for not post­ing re­sults from failed tri­al

In a first for the FDA, the agency on Wednes­day said that it sent a no­tice of non­com­pli­ance to Ac­celeron Phar­ma for its fail­ure to post re­sults from a can­cer tri­al, and said the com­pa­ny has 30 days to cor­rect this fail­ure or it may have to pay a $10,000 penal­ty or face crim­i­nal pros­e­cu­tion.

The let­ter opens a big can of worms for bio­phar­ma com­pa­nies, which have a le­gal re­spon­si­bil­i­ty to post tri­al re­sults to the gov­ern­ment’s data­base at Clin­i­cal­Tri­als.gov, gen­er­al­ly no lat­er than one year af­ter the study’s com­ple­tion date un­less a dead­line ex­ten­sion is ob­tained. But many com­pa­nies, even if they’re trans­par­ent about the re­sults, fail to up­date the list­ings in the data­base.

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