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FDA calls out Hims and oth­ers for GLP-1 ad­ver­tis­ing Read in browser
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1. Pfizer, Novartis, BMS, Lilly and others targeted in FDA's TV ad crackdown
2. In a first, FDA calls out Hims and other telehealth companies for GLP-1 advertising
3. RFK Jr.'s 'historic changes' to drug ads would trigger range of ripple effects
4. Top drug regulator pushes back on report that FDA wants to 'abandon' some adcomms
5. Covid-19 vaccine makers sidelined ahead of upcoming ACIP meeting, sources say
6. RFK Jr. adds five new ACIP panelists, including more vaccine critics and skeptics
7. Prasad regains chief medical and scientific officer roles at FDA
8. Short-term government spending bill includes OTC drug user fees
Zachary Brennan
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Ousted CDC Director Susan Monarez testified before the Senate HELP Committee today, offering another sign that RFK Jr. is facing more heat from fellow Republicans as his revamped ACIP meets Thursday and Friday. While the committee has set an agenda to vote on changes to CDC recommendations for MMR, Hepatitis B and Covid-19 vaccines, the largest association of US health insurers said Tuesday they will continue to cover all ACIP-recommended vaccines that were recommended as of the beginning of this month.

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Zachary Brennan
Senior Editor, Endpoints News
@ZacharyBrennan
FDA Commissioner Marty Makary (Drew Angerer/AFP via Getty Images)
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by Zachary Brennan

The FDA on Tues­day re­leased 40 let­ters sent to com­pa­nies as part of its crack­down on phar­ma­ceu­ti­cal ads, re­veal­ing some of its crit­i­cisms on how risks and ben­e­fits of drugs are pre­sent­ed.

The un­ti­tled let­ters con­cen­trat­ed most­ly on tele­vi­sion ads from Pfiz­er, No­var­tis, Bris­tol My­ers Squibb, Ab­b­Vie, Al­ny­lam, Boehringer In­gel­heim, Sanofi, As­traZeneca and oth­ers. Sev­er­al com­pa­nies re­ceived mul­ti­ple let­ters each.

Bris­tol My­ers, for ex­am­ple, re­ceived three un­ti­tled let­ters for "false or mis­lead­ing" TV ads re­lat­ed to their block­buster can­cer drug Op­di­vo and their car­diomy­opa­thy drug Camzyos. In the let­ter, the agency took is­sue with the safe­ty ex­pla­na­tions in each, among oth­er con­cerns.

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by Ngai Yeung

The FDA is­sued warn­ing let­ters to tele­health com­pa­nies for mak­ing "false or mis­lead­ing" claims about com­pound­ed GLP-1 obe­si­ty drugs.

The let­ters were part of a larg­er group of warn­ings post­ed on Tues­day that were sent to on­line phar­ma­cies, phar­ma­ceu­ti­cal gi­ants, tele­health star­tups and oth­er com­pa­nies as part of the Trump ad­min­is­tra­tion's clam­p­down on drug ad­ver­tis­ing.

Among the tele­health com­pa­nies that re­ceived let­ters were Hims & Hers and Rem­e­dy Meds, which bought fel­low dig­i­tal health plat­form Thir­ty Madi­son for $500 mil­lion. Both sell com­pound­ed ver­sions of pop­u­lar weight loss drugs. While these com­pound­ed drugs are not ap­proved by the FDA, they surged in pop­u­lar­i­ty over the past few years dur­ing the na­tion­wide short­age of GLP-1 drugs. Some tele­health com­pa­nies cap­i­tal­ized on the de­mand, build­ing en­tire busi­ness­es around the al­ter­na­tive ver­sions.

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by Zachary Brennan

For years, the end of every phar­ma­ceu­ti­cal ad has been a well-worn con­ven­tion: Af­ter smil­ing pa­tients are done walk­ing down the beach, or singing while walk­ing down the beach, a voice reads a sum­ma­ry of side ef­fects and risks that may come with treat­ment.

Un­der the FDA, those brief warn­ings have been a com­pro­mise be­tween reg­u­la­tor and in­dus­try, try­ing to strike a bal­ance be­tween what peo­ple will pay at­ten­tion to dur­ing a brief break in their show or game, and a com­plete pic­ture of the com­plex set of trade-offs that comes with many med­ica­tions.

This week's an­nounce­ment by the FDA that it plans to up­end that pol­i­cy on side ef­fects could com­plete­ly change — or dis­man­tle — that con­ven­tion, and po­ten­tial­ly drug ad­ver­tis­ing as a whole.

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CDER Director George Tidmarsh (FDA via YouTube)
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by Zachary Brennan

The FDA's top drug reg­u­la­tor de­nied a re­port that said he might "aban­don" cer­tain ad­vi­so­ry com­mit­tee meet­ings that of­ten re­view con­tro­ver­sial drug can­di­dates be­fore po­ten­tial ap­proval.

Cen­ter for Drug Eval­u­a­tion and Re­search Di­rec­tor George Tid­marsh said ear­li­er this week that the agency “would like to get away” from as­sem­bling its out­side ex­pert pan­els to ex­am­ine and vote on in­di­vid­ual drugs be­cause “I don’t think they’re need­ed," ac­cord­ing to a KFF Health News sto­ry pub­lished Fri­day. The re­port said FDA lead­ers seek to "aban­don" these ex­pert re­views.

When asked if he would aban­don or elim­i­nate ad­comms that fo­cus on in­di­vid­ual drug ap­pli­ca­tions, Tid­marsh de­nied it, telling End­points News, "Aban­don? I have nev­er said that."

Tid­marsh did not re­spond to a re­quest for more clar­i­ty on his views around ad­comms.

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by Max Bayer

Covid-19 shot mak­ers have not been work­ing close­ly with the CDC’s vac­cine ad­vi­sors and aren’t ex­pect­ed to make sub­stan­tive pre­sen­ta­tions to the pan­el when it con­venes lat­er this week, mul­ti­ple sources fa­mil­iar with the plan­ning told End­points News.

The CD­C's Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices is sched­uled to meet start­ing Thurs­day to dis­cuss and vote on rec­om­men­da­tions for he­pati­tis B, MM­RV and Covid-19 vac­cines. Sources told End­points that an agen­da item for Fri­day, list­ed as “COVID-19 Vac­cine Man­u­fac­tur­er up­dates,” will be an op­por­tu­ni­ty for the com­pa­nies to re­spond to ear­li­er pre­sen­ta­tions made dur­ing the meet­ing. Com­pa­nies have his­tor­i­cal­ly been al­lot­ted time dur­ing ACIP meet­ings to give de­tailed pre­sen­ta­tions on up­dat­ed vac­cine da­ta.

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HHS Secretary Robert F. Kennedy, Jr. (George Walker IV/AP Images)
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