OPDP let­ter crit­i­cizes drug com­pa­ny for fail­ing to dis­close risk in­fo on­line

The FDA Of­fice of Pre­scrip­tion Drug Pro­mo­tion (OPDP) on Mon­day un­veiled a new un­ti­tled let­ter sent last week to Michi­gan-based Rock­well Med­ical for a web­page that on­ly presents in­for­ma­tion about the ben­e­fits of its drug Trifer­ic (fer­ric py­rophos­phate cit­rate).

In OPDP’s 7th un­ti­tled let­ter of the year (two warn­ing let­ters were al­so is­sued), the of­fice ex­plains how the com­pa­ny omit­ted the risks as­so­ci­at­ed with Trifer­ic on its web­site, which means it failed to pro­vide ma­te­r­i­al in­for­ma­tion about the con­se­quences that may re­sult from the use of the drug and cre­at­ed a mis­lead­ing im­pres­sion about the safe­ty of Trifer­ic.

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