Not just the ap­proved in­di­ca­tions: FDA to study DTC drug ads that in­clude sec­ondary end­point da­ta

While most of the world bans di­rect-to-con­sumer ad­ver­tis­ing for pre­scrip­tion drugs, the FDA said Fri­day that it’s launch­ing a study in­to how peo­ple might per­ceive such ads that in­clude in­for­ma­tion on sec­ondary end­points that are not part of an ap­proved in­di­ca­tion.

The on­line re­search will ex­am­ine the im­pact of adding a dis­clo­sure about a sec­ondary claim (i.e. clin­i­cal ben­e­fit in­for­ma­tion based on a sec­ondary end­point re­port­ed in a prod­uct’s ap­proved la­bel­ing) in DTC and health­care provider-di­rect­ed on­line pro­mo­tions.

“In some cas­es, truth­ful and non-mis­lead­ing pre­sen­ta­tions about sec­ondary end­points in well-de­signed clin­i­cal stud­ies can pro­vide re­li­able in­for­ma­tion about treat­ment ef­fects that may be dis­tinct from the treat­ment ef­fects de­scribed in the prod­uct’s in­di­ca­tion state­ment,” FDA said in the Fed­er­al Reg­is­ter ex­plain­ing the need for the re­search.

The agency of­fered the ex­am­ple of a can­cer drug in­di­cat­ed to treat a spe­cif­ic type of can­cer based on a pri­ma­ry end­point of sur­vival, where­as a sec­ondary end­point in the study may pro­vide da­ta about an ad­di­tion­al dis­tinct ben­e­fit, such as func­tion­al sta­tus.

For this re­search, the agency is fo­cus­ing on di­a­betes drugs and the sec­ondary claim dis­clo­sure that ex­plains “even though the drug is not in­di­cat­ed for weight loss, that it can help some peo­ple lose weight.”

One com­menter on the re­search said it “lacks prac­ti­cal util­i­ty” be­cause it treats the sec­ondary ben­e­fit claim as not re­lat­ed to the prod­uct’s in­di­cat­ed us­es.

But FDA said it’s not mak­ing any gen­er­al­iza­tions about the ap­proval sta­tus of the sec­ondary claim, adding, “In this sce­nario, a dis­clo­sure about the sec­ondary claim may help the au­di­ence in­ter­pret the sec­ondary claim and pro­vide con­text. The pur­pose of this study is to eval­u­ate such dis­clo­sures about this spe­cif­ic type of sec­ondary claim and mea­sure the im­pact on per­cep­tions of and at­ti­tudes to­ward the prod­uct.”

In re­sponse to an­oth­er ques­tion on whether it’s ap­pro­pri­ate for the FDA to study the prac­tice of med­i­cine, the agency de­fend­ed the need for this re­search, claim­ing, “It is a prop­er sub­ject for FDA re­search to study whether par­tic­u­lar fram­ing of state­ments con­tributes to an HCP’s ac­cu­rate un­der­stand­ing or to mis­un­der­stand­ing about drugs to in­form their pre­scrib­ing de­ci­sions in the course of their prac­tice of med­i­cine.”

In ad­di­tion to the sec­ondary claims re­search, the agency al­so said it’s work­ing on an­oth­er study re­lat­ed to the dis­clo­sure that a cer­tain prod­uct is a biosim­i­lar.

FDA said the pur­pose of that study is “to un­der­stand whether par­tic­i­pants would ask their doc­tor to switch their med­ica­tion af­ter view­ing the ad.”

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