FDA slams small phar­ma for mis­lead­ing ad with a dearth of safe­ty in­fo and du­bi­ous stat cal­cu­la­tions

The FDA’s Of­fice of Pre­scrip­tion Drug Pro­mo­tion slapped its 3rd un­ti­tled let­ter of the year on­to New Jer­sey-based Al­thera Phar­ma­ceu­ti­cals ear­li­er this month, with the agency say­ing the firm’s DTC ad cre­at­ed a mis­lead­ing im­pres­sion about the safe­ty pro­file of its cho­les­terol drug Roszet (ro­su­vas­tatin and eze­tim­ibe) and com­bined study re­sults in an un­ortho­dox way.

The pro­mo, which came in the form of a pam­phlet, in­clud­ed “sci­en­tif­i­cal­ly un­sound analy­sis,” ac­cord­ing to the FDA, as it de­picts num­bers that were “ret­ro­spec­tive­ly cal­cu­lat­ed by com­bin­ing the re­sults of two un­re­lat­ed stud­ies, nei­ther of which eval­u­at­ed the spe­cif­ic com­bi­na­tion of ro­su­vas­tatin and eze­tim­ibe.”

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