Eli Lil­ly serves up a win over Biden's HHS in drug dis­count court case

In the bat­tle over a grow­ing fed­er­al drug dis­count pro­gram and whether phar­ma com­pa­nies can uni­lat­er­al­ly change what en­ti­ties re­ceive cer­tain dis­counts, the in­dus­try was just dealt a win from a US dis­trict court.

Sarah Evans Bark­er

The In­di­ana court ruled that a let­ter from HHS to drug­mak­ers in May, which said their uni­lat­er­al changes to the dis­counts were il­le­gal, is “ar­bi­trary and capri­cious.” Now HRSA, which runs the 340B drug dis­count pro­gram, has to come up with fur­ther con­sid­er­a­tion/ac­tion con­sis­tent with the opin­ion.

The win is good news for the oth­er five com­pa­nies cit­ed in that let­ter too, in­clud­ing No­var­tis, No­vo Nordisk, Sanofi and Unit­ed Ther­a­peu­tics, and like­ly means the com­pa­nies will not be as­sessed fines.

How­ev­er, the opin­ion al­so makes clear that “the statute, cor­rect­ly con­strued, does not per­mit drug man­u­fac­tur­ers, such as Lil­ly, to im­pose uni­lat­er­al ex­tra statu­to­ry re­stric­tions on its of­fer to sell 340B drugs to cov­ered en­ti­ties uti­liz­ing mul­ti­ple con­tract phar­ma­cy arrange­ments,” judge Sarah Evans Bark­er wrote.

But in the end, she ex­plained how the agency’s May let­ter “fails to ac­knowl­edge or ex­plain the agency’s changed po­si­tion(s) with re­gard to its au­thor­i­ty to en­force statu­to­ry com­pli­ance when the al­leged vi­o­la­tion is en­tan­gled with a reg­u­lat­ed en­ti­ty’s fail­ure to com­ply with the agency’s non­bind­ing con­tract phar­ma­cy guid­ance.”

The size of the bal­loon­ing 340B pro­gram, which is now the sec­ond-largest fed­er­al drug dis­tri­b­u­tion/fi­nanc­ing pro­gram and in­volves 30 bil­lion dis­count­ed pur­chas­es each year, was a con­stant theme in the court’s opin­ion. It al­so seemed to place the onus on Con­gress to make changes to 340B.

“The de­mand for 340B drugs and the preva­lence of con­tract phar­ma­cies has ex­plod­ed in a way that Con­gress like­ly did not imag­ine ei­ther when the statute was first en­act­ed in 1992,” Bark­er wrote. “Giv­en the ex­pan­sion of the 340B pro­gram and the vast pro­lif­er­a­tion of con­tract phar­ma­cy arrange­ments since Con­gress’s most re­cent amend­ments to the 340B statute, Con­gress may at some point choose to amend the statute to di­rect­ly ad­dress these is­sues. But that is for Con­gress to de­ter­mine; drug man­u­fac­tur­ers may not usurp the role through uni­lat­er­al ex­tra-statu­to­ry re­stric­tions.”

She al­so not­ed ex­am­ples of some 340B-cov­ered en­ti­ties that lost ac­cess to hun­dreds of thou­sands in dis­counts. “A crit­i­cal-ac­cess hos­pi­tal in Ne­bras­ka doc­u­ment­ed nu­mer­ous in­stances where it paid prices far above the 340B ceil­ing price for Lil­ly drugs, in­clud­ing in­stances where it paid $326, $339, $551, and $797 for Lil­ly in­sulin,” the opin­ion notes.

How­ev­er, Lil­ly won the de­ci­sion in the end be­cause HRSA, which runs the pro­gram un­der HHS, has “failed even to ac­knowl­edge any change in its po­si­tion re­gard­ing its abil­i­ty to take en­force­ment ac­tion re­lat­ed to drug man­u­fac­tur­ers’ deal­ings with cov­ered en­ti­ties through con­tract phar­ma­cy arrange­ments, much less pro­vide ‘good rea­sons’ for such change, the de­ter­mi­na­tions in the May 17 Let­ter are ar­bi­trary and capri­cious and must be set aside and va­cat­ed and the is­sues re­mand­ed to the agency as ac­tions vi­ola­tive of the APA.”

HHS’ ar­gu­ments would “car­ry more weight if,” she not­ed, if “pri­or to the is­suance of the Ad­vi­so­ry Opin­ion, the agency had not in­di­cat­ed on sev­er­al oc­ca­sions that its en­force­ment pow­ers were lim­it­ed and that it lacked au­thor­i­ty to ‘com­pel[]’ man­u­fac­tur­ers ‘to pro­vide 340B dis­counts on drugs dis­pensed by con­tract phar­ma­cies.'”

But it wasn’t all good news for the phar­ma in­dus­try, ei­ther, as she poked holes in many of its ar­gu­ments and laid out sev­er­al key ques­tions, not­ing:

We do not know, for ex­am­ple, why the agency said for so long that it was no­table to en­force its view of drug man­u­fac­tur­ers’ oblig­a­tions un­der the statute in the con­text of con­tract phar­ma­cy arrange­ments and then sud­den­ly changed tack and said it was able to en­force these re­quire­ments. We can­not di­vine whether Con­gress in­tend­ed for drug man­u­fac­tur­ers to have un­lim­it­ed de­liv­ery oblig­a­tions un­der the statute, un­teth­ered to the par­tic­u­lar cov­ered en­ti­ty’s ac­tu­al dis­tri­b­u­tion needs. We have no in­sight in­to why there is ap­par­ent­ly so much re­luc­tance to pro­mul­gate a holis­tic leg­isla­tive pro­pos­al to bring clar­i­ty to the scope of the reg­u­lat­ed par­ties’ oblig­a­tions and en­ti­tle­ments un­der the statute with re­gard to con­tract phar­ma­cy arrange­ments rather than en­gage in piece­meal in­ter­pre­ta­tions and af­ter the fact patch­work char­ac­ter­iz­ing the his­to­ry of the agency’s at­tempts to man­age this pro­gram.

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.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

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.