‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New re­search shows how gener­ic drug com­pa­nies can suc­cess­ful­ly mar­ket a lim­it­ed num­ber of ap­proved in­di­ca­tions for a brand name drug, pri­or to com­ing to mar­ket for all of the in­di­ca­tions. But sev­er­al re­cent court de­ci­sions have cre­at­ed a lay­er of un­cer­tain­ty around these so-called “skin­ny” la­bels.

Aaron Kessel­heim

While courts have gen­er­al­ly al­lowed gener­ic man­u­fac­tur­ers to use their statu­to­ri­ly per­mit­ted skin­ny-la­bel ap­provals, last sum­mer, a fed­er­al cir­cuit court found that Te­va Phar­ma­ceu­ti­cals was li­able for in­duc­ing pre­scribers and pa­tients to in­fringe Glax­o­SmithK­line’s patents through ad­ver­tis­ing and mar­ket­ing prac­tices that sug­gest­ed Te­va’s gener­ic, with its skin­ny la­bel, could be em­ployed for the patent­ed us­es.

“Te­va was a prob­lem­at­ic de­ci­sion be­cause it made it hard­er for gener­ic com­pa­nies to do what they’re legal­ly al­lowed to do,” Har­vard med­ical pro­fes­sor Aaron Kessel­heim told End­points News.

Kessel­heim and col­leagues at Har­vard’s Pro­gram On Reg­u­la­tion, Ther­a­peu­tics, And Law pub­lished a pa­per on Tues­day in the Jour­nal of Clin­i­cal On­col­o­gy that looks in­to how the skin­ny la­bel for gener­ic ver­sions of the can­cer drug Gleevec worked.

What they found was that gener­ic ver­sions of Gleevec were dis­pensed fre­quent­ly for in­di­ca­tions that were both in­clud­ed and ex­clud­ed from the skin­ny la­bel­ing, al­though pa­tients with one of the ex­clud­ed in­di­ca­tions were “slight­ly less like­ly to re­ceive a gener­ic ver­sion.”

Those on the gener­ic saved mon­ey.

“We found that out-of-pock­et costs for brand-name ima­tinib far ex­ceed­ed such costs for gener­ics for pa­tients with cer­tain types of in­sur­ance, al­though we were un­able to ac­count for coupons or pa­tient as­sis­tance pro­grams that might off­set these out-of-pock­et costs for some pa­tients,” the re­searchers wrote.

They al­so called on Con­gress to cre­ate an ex­emp­tion to shield physi­cians and phar­ma­cists from le­gal li­a­bil­i­ty for writ­ing pre­scrip­tions for gener­ics or sub­sti­tut­ing gener­ics in place of brand-name drugs in cas­es when one or more in­di­ca­tions are carved out of the gener­ic la­bel­ing.

Bryan Walsh

“Con­gress has cre­at­ed a sim­i­lar ex­cep­tion for med­ical or sur­gi­cal pro­ce­dure patents that al­lowed the is­suance of patents for such pro­ce­dures or tech­niques, but shield­ed physi­cians and re­lat­ed health care en­ti­ties from li­a­bil­i­ty for patent in­fringe­ment,” they wrote.

Co-au­thor of the pa­per Bryan Walsh al­so told End­points that there is added un­cer­tain­ty from the re­cent Amarin v. Hik­ma opin­ion, where a court threw out a chal­lenge to the skin­ny la­bel on a fish oil drug.

“The court, in this case, sided with the gener­ic com­pa­ny in dis­miss­ing Amarin’s law­suit – yet the facts were ex­treme­ly sim­i­lar to those pre­sent­ed in the GSK v. Te­va case. Ul­ti­mate­ly it will be up to the low­er courts to de­ter­mine how (or if) the GSK v. Te­va should be fac­tored in­to fu­ture law­suits, cre­at­ing more un­cer­tain­ty for gener­ics look­ing to de­vel­op skin­ny la­bel gener­ic ver­sions of brand-name drugs,” Walsh said.

And while the Fed­er­al Cir­cuit’s ma­jor­i­ty said in its opin­ion that its “nar­row, case-spe­cif­ic re­view of sub­stan­tial ev­i­dence does not up­set the care­ful bal­ance struck by the Hatch-Wax­man Act” re­gard­ing la­bel carve-outs, con­cerns re­main around the un­cer­tain­ty of these skin­ny la­bels.

“Skin­ny-la­beled gener­ics can pro­vide sub­stan­tial sav­ings for pa­tients and the health care sys­tem by help­ing cir­cum­vent a com­mon gener­ic-de­lay­ing prac­tice used by brand-name man­u­fac­tur­ers,” the au­thors con­clud­ed.

Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.

Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Pfiz­er, Bris­tol My­ers dom­i­nate top 10 pre­dic­tions for the best-sell­ing drugs of 2022

The annual exercise where analysts try and predict which drugs will become blockbusters and make the most money tends to highlight the biggest trends in biopharma R&D. 2022 is no exception.

The team at Evaluate Vantage published its predictions for the top 10 selling drugs for the year — expecting tens of billions of dollars in sales and highlighting an industry-wide focus on certain diseases and indications.

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