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.”

With rumors swirling about a potential buyout of biotech Acceleron and its lead PAH drug sotatercept, market watchers have been keeping close tabs on industry movers and shakers due up for an expensive bolt-on. According to a new report, it appears Merck may be the one.

Merck is in “advanced talks” on a deal to acquire Cambridge, MA-based Acceleron in what previous reports pegged as a potential $11 billion buyout, the Wall Street Journal reported Monday. A deal could come as early as this week, according to the Journal.

FDA’s top vaccine official Peter Marks is pulling the plug on a months-long transition for two top career vaccine officials who abruptly called it quits in late August.

Marion Gruber, director of the FDA’s Office of Vaccines Research & Review and 32-year veteran of the agency, her deputy director Phil Krause, announced their departures and then raised concerns with Covid-19 booster shots ahead of and during a recent Covid-19 booster vaccine advisory committee.

Pfizer and BioNTech said Tuesday they submitted to FDA positive data from a Phase II/III trial of their Covid-19 vaccine in children aged 5 to less than 12 years old.

A formal EUA submission for the vaccine in these children is expected to follow “in the coming weeks,” the companies said in a statement.

The trial of 2,268 healthy participants aged 5 to less than 12 years old showed the vaccine was safe and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses, which is one-third the dose that’s administered to adults.

Biogen — together with partners at Eisai — will be the first to breeze down that Alzheimer’s trail it blazed with the FDA’s historic and controversial accelerated approval of Aduhelm.

Eisai disclosed it’s initiated a rolling BLA submission for lecanemab, or BAN2401, the anti-amyloid beta antibody that Biogen has long touted as a follow-on to Aduhelm (then aducanumab). Following the precedent that the agency has now set, the two companies are gunning for an OK based on data suggesting that the drug could lower amyloid beta plaques.