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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER