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.”

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”