In a first for 2022, the FDA’s Of­fice of Pre­scrip­tion Drug Pro­mo­tion has is­sued an un­ti­tled let­ter, which was re­cent­ly sent to Eli Lil­ly over what the agency calls a “mis­lead­ing” and “par­tic­u­lar­ly con­cern­ing” In­sta­gram ad the com­pa­ny post­ed for its type 2 di­a­betes drug Trulic­i­ty.

The ques­tion­able In­sta­gram post, which has since been delet­ed by Lil­ly, failed to ad­e­quate­ly com­mu­ni­cate the in­di­ca­tion and lim­i­ta­tions of use as­so­ci­at­ed with Trulic­i­ty, FDA says.

The post “cre­ates a mis­lead­ing im­pres­sion about the scope of the FDA-ap­proved in­di­ca­tion. This is par­tic­u­lar­ly con­cern­ing giv­en the se­ri­ous risks of this prod­uct and the sug­ges­tion that Trulic­i­ty will help ‘low­er A1C’ in all pa­tients, when this has not been demon­strat­ed,” the agency writes, not­ing that it was alert­ed to the ad via com­plaints to its Bad Ad pro­gram.

What’s more is that FDA said that this isn’t the first time it’s warned Lil­ly on Trulic­i­ty ads.

“We are con­cerned that Lil­ly is pro­mot­ing Trulic­i­ty with­out pre­sent­ing the ben­e­fits and se­ri­ous risks of the drug in a truth­ful and non-mis­lead­ing man­ner, de­spite con­cerns pre­vi­ous­ly ex­pressed by OPDP,” FDA writes in its par­tial­ly redact­ed let­ter to Lil­ly’s man­ag­er Ann Ro­bards.

OPDP al­so takes is­sue with the pre­sen­ta­tion of the ad, not­ing that the in­di­ca­tion and the lim­i­ta­tions of use are on­ly in “small, fast-paced scrolling font in a small win­dow be­low the video, rel­e­gat­ed to the bot­tom of the post, com­pet­ing for the con­sumer’s at­ten­tion with sev­er­al dis­tract­ing video el­e­ments (fast paced vi­su­als, fre­quent scene changes, busy scenes, large-mov­ing su­per­im­posed text, and a strong fast-mov­ing mu­si­cal beat) that de­tract from the com­mu­ni­ca­tion of the in­di­ca­tion and lim­i­ta­tions of use. There­fore, this pre­sen­ta­tion does not mit­i­gate the mis­lead­ing im­pres­sion cre­at­ed by the post.”

The agency fur­ther ex­plains how the ad pre­sen­ta­tion fails to in­clude ma­te­r­i­al in­for­ma­tion from Trulic­i­ty’s warn­ing and pre­cau­tion for hy­po­glycemia with con­comi­tant use of in­sulin sec­re­t­a­gogues or in­sulin.

Lil­ly said in an emailed state­ment:

The sub­ject ad was im­me­di­ate­ly re­moved from the Trulic­i­ty In­sta­gram ac­count the same day the let­ter was re­ceived, and we will be pro­vid­ing the FDA a full re­sponse to en­sure the is­sue is ad­dressed. We are con­duct­ing a full re­view of all ac­tive Trulic­i­ty pro­mo­tion­al ma­te­ri­als, and any ma­te­ri­als that con­tain­ing rep­re­sen­ta­tions de­scribed in the let­ter will be re­vised or dis­con­tin­ued. The ap­pro­pri­ate use and pro­mo­tion of our med­i­cines is of the ut­most im­por­tance at Lil­ly, and we are com­mit­ted to com­ply­ing with all ap­plic­a­ble laws and reg­u­la­tions.

FDA late last year al­so sent an­oth­er un­ti­tled let­ter to Lil­ly for TV ads for its mi­graine drug Em­gal­i­ty, which the agency said make “false or mis­lead­ing claims.”

What makes these OPDP un­ti­tled let­ters to Lil­ly unique is how in­fre­quent­ly the agency now sends them out. In 2020 and 2021 com­bined, OPDP sent out just 6 un­ti­tled let­ters, where­as in 2010 and ear­li­er, OPDP sent out many more.

Ed­i­tor’s note: Ar­ti­cle up­dat­ed with Lil­ly com­ment.

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

As Neulasta sales slip, Amgen has yet another biosimilar to look out for: Amneal Pharmaceuticals and Kashiv Biosciences’ Flynetra.

Flynetra became the fifth approved biosimilar to Neulasta on Friday, snagging a win in neutropenia, a condition common among chemotherapy patients where neutrophils, a type of white blood cell that fights infection, are too low.

As of last summer, the list price of Neulasta was more than $6,400 per dose. It’s designed to be taken in a single dose per chemotherapy cycle. Amneal declined to reveal how much it intends to charge for Flynetra in an email to Endpoints News.