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What more can we learn from DTC ad­ver­tis­ing? FDA's OPDP pro­pos­es new re­search

How do specifics around en­dorse­ments, mech­a­nism of ac­tion and med­ica­tion track­ing in phar­ma­ceu­ti­cal ads im­pact con­sumers? That’s what the FDA’s Of­fice of Pre­scrip­tion Drug Pro­mo­tion (OPDP) wants to find out in three new stud­ies.

OPDP has pro­posed three re­search projects on di­rect-to-con­sumer mar­ket­ing, ac­cord­ing to fed­er­al reg­is­ter no­tices post­ed last week. The stud­ies would join the agency’s ros­ter of 13 on­go­ing projects cov­er­ing a wide range of top­ics, from ac­cel­er­at­ed ap­proval dis­clo­sure to in­ter­pre­ta­tion of drug names.

How­ev­er, while ac­knowl­edg­ing the im­por­tance of such re­search, one FDA reg­u­la­to­ry watch­dog said in a re­cent blog post that the new stud­ies are “more of the same old fo­cus.”

“They’ve built up a huge body of re­search, and a lot of it is very nu­anced, re­al­ly fo­cus­ing in on the im­pact of very spe­cif­ic sit­u­a­tions in terms of pro­mo­tion­al com­mu­ni­ca­tions,” Mark Senak, a lawyer at Fleish­man­Hillard who tracks FDA ac­tions on his Eye on FDA blog, told End­points News on Wednes­day.

“The thing is, since 2008, let’s say, there’s been a huge mi­gra­tion in terms of me­dia con­sump­tion and health-seek­ing in­for­ma­tion us­ing the in­ter­net and dig­i­tal and so­cial com­mu­ni­ca­tions, and I have not seen a cor­re­spond­ing shift in the em­pha­sis of the re­search that fol­lows that,” he added.

The new stud­ies would ex­am­ine the type and dis­clo­sure of en­dorse­ments in TV ads, pro­mo­tion of med­ica­tion track­ing tools, and use of graph­ics and tar­get­ed mech­a­nism of ac­tion claims to ex­plain how a drug works.

The lat­ter pro­pos­al builds on a se­ries of fo­cus groups OPDP host­ed in 2014 to de­ter­mine how con­sumers in­ter­pret the word “tar­get­ed” in pro­mo­tion­al ma­te­ri­als.

“Al­though di­verse views were voiced, there ap­peared to be some ten­den­cy to­ward the im­pres­sion that prod­ucts with pro­mo­tion­al ma­te­ri­als us­ing this term would be safer and more ef­fec­tive than oth­er sim­i­lar treat­ments,” OPDP’s no­tice states.

Re­searchers in the new study would in­ves­ti­gate how con­sumers view graph­ics and oth­er spe­cif­ic mech­a­nism of ac­tion dis­clo­sures on a web­page for a fake drug.

The sec­ond study, en­ti­tled “Per­cep­tions of Pre­scrip­tion Drug Prod­ucts With Med­ica­tion Track­ing Ca­pa­bil­i­ties,” al­so us­es a fic­ti­tious web­page to gauge con­sumers’ thoughts on the use of soft­ware such as smart­phone apps to track med­ica­tion use.

The first, how­ev­er, homes in on TV mar­ket­ing, which still ac­counts for a sig­nif­i­cant por­tion of ad­ver­tis­ers’ bud­gets, de­spite ef­forts to di­ver­si­fy the ad­ver­tis­ing me­dia mix, with on­line video and au­dio pro­gram­ming on the rise.

While an on­go­ing OPDP study has ex­am­ined the im­pact of dif­fer­ent types of en­dorsers for phar­ma­ceu­ti­cal drugs on­line and in print, this study would ex­am­ine ac­tu­al-use dis­clo­sures in TV ads.

“Pri­or re­search has shown that en­dorse­ments by ex­pert physi­cians and phar­ma­cists were the most like­ly to lead to pur­chase in­ten­tions, fol­lowed by en­dorse­ments by con­sumers, and last­ly, by celebri­ties,” OPDP said.

“It feels like even though a lot of peo­ple are get­ting their in­for­ma­tion via so­cial and dig­i­tal, the re­search hasn’t looked in­to the nu­ance of that to the same de­gree that they con­tin­ue dig­ging in the vein of DTC broad­cast,” Senak said. “Heck, phar­ma’s even us­ing Tik­Tok at this point.”

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

Before Roche can turn all eyes on a new version of its more-than-once-failed Alzheimer’s drug gantenerumab, the Big Pharma had to flesh out data on the November topline failure at an annual conference buzzier than in years past thanks to hotly watched rivals in the field: Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab.

There was less than a 10% difference between Roche’s drug and placebo at slowing cognitive decline across two Phase III trials, which combined enrolled nearly 2,000 Alzheimer’s patients. In its presentation at the conference Wednesday, Roche said it saw less sweeping away of toxic proteins than it had anticipated. For years, researchers and investors have put their resources behind the idea that more amyloid removal would equate to reduced cognitive decline.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Fed­er­al claims court rules in fa­vor of Gilead in CDC Tru­va­da patent case

Gilead pulled a win last week in its ongoing patent battle with the CDC over the HIV drug Truvada for pre-exposure prophylaxis (PrEP).

The US Court of Federal Claims ruled on Nov. 21 that the government breached certain agreements with Gilead by failing to promptly notify the company of its patent applications for Truvada for PrEP, according to documents unsealed on Wednesday.

The issue traces back to around 2004 when Truvada won an accelerated approval to treat HIV. Because HIV is known to develop resistance to therapy, patients at the time were often required to take more than one drug at a time. Truvada combines Gilead’s prior HIV drugs, Emtriva and Viread, making life easier for patients who were taking separate pills daily. Shortly after, the CDC and Gilead struck up a partnership to research Truvada’s use as a preventative measure prior to exposure.