As drug­mak­ers spend $6B an­nu­al­ly on DTC ads, sen­a­tors re­vive bill to in­clude list prices in ads

Dick Durbin

A new GAO re­port on bio­phar­ma com­pa­nies’ $6 bil­lion an­nu­al spend­ing on di­rect-to-con­sumer ad­ver­tis­ing is push­ing US Sen­ate Ma­jor­i­ty Whip Dick Durbin (D-IL) and Sen. Chuck Grass­ley (R-IA) to rein­tro­duce leg­is­la­tion that would re­quire price dis­clo­sures in the ads.

The GAO found that drug­mak­ers spent al­most half—$8.2 bil­lion of the $17.8 bil­lion from 2016 to 2018—on DTC ads for drugs in three ther­a­peu­tic cat­e­gories, in­clud­ing in­flam­ma­to­ry con­di­tions (e.g., arthri­tis, gout), en­docrine and meta­bol­ic dis­or­ders (e.g., type 2 di­a­betes, hy­pothy­roidism), and con­di­tions af­fect­ing the cen­tral ner­vous sys­tem (e.g., de­pres­sion, mul­ti­ple scle­ro­sis), ac­cord­ing to the new re­port.

At the very top of that list is Ab­b­Vie’s rheuma­toid arthri­tis megablock­buster Hu­mi­ra, which saw $1.4 bil­lion in new DTC ads from 2016 to 2018, while Eli Lil­ly’s type 2 di­a­betes bi­o­log­ic Trulic­i­ty ($655 mil­lion) and Pfiz­er’s neu­ro­path­ic pain drug Lyri­ca ($913 mil­lion) had the high­est spend­ing across the 3 years among drugs that treat en­docrine and meta­bol­ic dis­or­ders and con­di­tions af­fect­ing the cen­tral ner­vous sys­tem, re­spec­tive­ly.

GAO al­so said that man­u­fac­tur­er spend­ing on con­sumer ad­ver­tis­ing may have been one of sev­er­al fac­tors con­tribut­ing to in­creas­es in Medicare ben­e­fi­cia­ry use and spend­ing from 2010 to 2018.

Chuck Grass­ley

Durbin and Grass­ley re­quest­ed the GAO re­port and said the find­ings con­firm the need for re­forms.

“GAO doc­u­ment­ed Phar­ma’s tried and true scheme: Amer­i­ca’s se­niors are be­ing tar­get­ed with ads for ex­pen­sive med­ica­tions with­out dis­clos­ing the price of the drug, then Medicare spend­ing is in­flat­ed to the tune of tens of bil­lions of dol­lars each year,” the sen­a­tors said in a state­ment. “We plan to in­tro­duce new leg­is­la­tion to bring trans­paren­cy to Phar­ma’s un­fair drug ad­ver­tis­ing prac­tices by re­quir­ing the dis­clo­sure of the prod­uct’s cost, which will low­er drug spend­ing and em­pow­er pa­tients.”

That push for trans­paren­cy will need some leg­isla­tive help as US Dis­trict Court Judge Amit Mehta ruled in Ju­ly 2019 that HHS lacks the au­thor­i­ty to re­quire drug­mak­ers to post list prices in DTC ads.

Am­gen, Mer­ck, Eli Lil­ly and the As­so­ci­a­tion of Na­tion­al Ad­ver­tis­ers sued HHS over the po­ten­tial rule, claim­ing that the list prices are not what pa­tients pay and that the agency does not have the au­thor­i­ty for such a rule­mak­ing.

Mehta sided with the phar­ma­ceu­ti­cal com­pa­nies and said the rule is in­valid, while ac­knowl­edg­ing that “the costs im­posed by the WAC Dis­clo­sure Rule amount to a round­ing er­ror for the phar­ma­ceu­ti­cal in­dus­try. But that ar­gu­ment miss­es the point. It is the agency’s in­cur­sion in­to a brand-new reg­u­la­to­ry en­vi­ron­ment, and the ra­tio­nale for it, that make the Rule so con­se­quen­tial. To ac­cept the agency’s jus­ti­fi­ca­tion here would swing the doors wide open to any reg­u­la­tion, rule, or pol­i­cy that might rea­son­ably re­sult in cost sav­ings to the Medicare and Med­ic­aid pro­grams, un­less ex­press­ly pro­hib­it­ed by Con­gress.”

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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Sanofi preps a multi­bil­lion-dol­lar buy­out of an mR­NA pi­o­neer af­ter falling be­hind in the race for a Covid-19 jab — re­port

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

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Bris­tol My­ers pulls lym­phoma in­di­ca­tion for Is­to­dax af­ter con­fir­ma­to­ry tri­al falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

Rick Pazdur (via AACR)

FDA's on­col­o­gy head Rick Paz­dur de­fends the ac­cel­er­at­ed ap­proval path­way, claim­ing it is 'un­der at­tack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

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UP­DAT­ED: Watch out Glax­o­SmithK­line: As­traZeneca's once-failed lu­pus drug is now ap­proved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

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How the bio­phar­ma in­dus­try is help­ing to pay for the bi­par­ti­san in­fra­struc­ture bill

Senators on Sunday finalized the text of a massive, bipartisan infrastructure bill that contains little that might impact the biopharma industry other than two ways the legislators are planning to pay for the $1.2 trillion deal.

On the one hand, senators are seeking to further delay a Trump-era Medicare Part D rule related to drug rebates, this time until 2026. Senators claim the rule could end up saving about $49 billion, but the PBM industry has attacked it as it would remove rebates from a safe harbor that provides protection from federal anti-kickback laws. The pharmaceutical industry, however, is in favor of the rule and opposes this latest delay as it continues to point its finger at the PBM industry for the rising cost of out-of-pocket expenses.

Not all mR­NA vac­cines are cre­at­ed equal. Does it mat­ter?; Neu­ro is back; Pri­vate M&A af­fair; and more

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As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

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FTC pulls re­main­ing case against Ab­b­Vie; New EU clin­i­cal tri­als sys­tem com­ing in 2022; Abing­worth bets big on CymaBay

The Federal Trade Commission on Friday withdrew its remaining case against AbbVie after the Supreme Court declined to review a lower court’s ruling.

The punt by SCOTUS means that while the Illinois pharma company illegally blocked patients’ access to lower-cost alternatives to its testosterone drug AndroGel, the FTC will no longer be able to return about $500 million directly to AndroGel consumers.