FDA’s drug pro­mo­tion watch­dog plans study around ad­her­ence claims in phar­ma ads

The FDA wants to know if drug ad­ver­tise­ments with ad­her­ence claims in­flu­ence con­sumer and physi­cian opin­ions of pre­scrip­tion prod­ucts. It’s propos­ing the “Ad­her­ence Po­ten­tial and Pa­tient Pref­er­ence in Pre­scrip­tion Drug Pro­mo­tion” study by the Of­fice of Pre­scrip­tion Drug Pro­mo­tion (OPDP) pref­aced by a 60-day pe­ri­od for com­ments through Dec. 11.

OPDP plans to show study par­tic­i­pants dif­fer­ent ver­sions of a web­site for a fic­ti­tious type 2 di­a­betes drug. Each per­son will see one of eight web pages with vary­ing claims around im­plied ad­her­ence, pa­tients’ pref­er­ence, or a dis­clo­sure stat­ing there is no con­clu­sive da­ta on ad­her­ence. It plans to in­clude both con­sumers and pri­ma­ry care physi­cians in its pretest­ing, but for the main study it will query pa­tients who self-iden­ti­fy as hav­ing di­a­betes and physi­cians who treat di­a­betes.

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