Drug­mak­ers sue HHS for try­ing to add prices to DTC ads

Am­gen, Mer­ck, Eli Lil­ly and the As­so­ci­a­tion of Na­tion­al Ad­ver­tis­ers on Fri­day sued the De­part­ment of Health and Hu­man Ser­vices (HHS) be­cause of a rule­mak­ing that would re­quire phar­ma­ceu­ti­cal list prices to be shown in di­rect-to-con­sumer (DTC) drug ad­ver­tise­ments on tele­vi­sion.

The rule, which was fi­nal­ized in May and is set to take ef­fect in Ju­ly, re­quires that tele­vi­sion ad­ver­tise­ments for pre­scrip­tion drugs or bi­o­log­i­cal prod­ucts with a list price of $35 or more con­tain a state­ment in­di­cat­ing the Whole­sale Ac­qui­si­tion Cost (al­so re­ferred to as WAC or the list price) for a typ­i­cal 30-day reg­i­men or for a typ­i­cal course of treat­ment.

But in their law­suit, file in the US Dis­trict Court for the Dis­trict of Co­lum­bia, the drug­mak­ers took is­sue with the fact that con­sumers do not pay the list prices that would be ad­ver­tised un­der the rule.

“The rule thus di­rects man­u­fac­tur­ers to ad­ver­tise to con­sumers the price that man­u­fac­tur­ers charge to whole­salers, even though these are two en­tire­ly dif­fer­ent con­cepts,” the com­plaint says. “And be­cause third-par­ty pay­ers (like in­sur­ance plans or gov­ern­ment health pro­grams) gen­er­al­ly cov­er the bulk of the costs of a brand­ed drug, the over­whelm­ing ma­jor­i­ty of pa­tients do not pay any­thing re­mote­ly close to the Whole­sale Ac­qui­si­tion Cost of an ad­ver­tised drug at the phar­ma­cy or through their provider.”

For in­stance, rarely does any­one on Med­ic­aid, HHS’ pro­gram to help those with lim­it­ed in­comes or re­sources, pay more than an $8 co-pay, the suit claims.

“Be­yond be­ing en­tire­ly un­nec­es­sary, bad for pa­tients, and detri­men­tal to health care,” the drug­mak­ers al­so claim that the rule is un­law­ful for two rea­sons: HHS lacks the statu­to­ry au­thor­i­ty to im­pose the rule and it vi­o­lates the First Amend­ment.

The gov­ern­ment “bears a heavy bur­den to jus­ti­fy laws com­pelling speech, even in the com­mer­cial are­na,” the suit says, not­ing that HHS has “no le­git­i­mate in­ter­est, much less a sub­stan­tial one, in forc­ing phar­ma­ceu­ti­cal man­u­fac­tur­ers to make state­ments in di­rect-to-con­sumer mes­sag­ing that it con­cedes may mis­lead pa­tients about their out-of-pock­et costs for med­ica­tions.”

As far as HHS’s statu­to­ry au­thor­i­ty, the suit says this “claim to have dis­cov­ered such ex­pan­sive pow­er in a pair of decades-old gen­er­al rule­mak­ing pro­vi­sions of the So­cial Se­cu­ri­ty Act is sim­ply not cred­i­ble.

“Orig­i­nal­ly, HHS in­di­cat­ed that it hoped the FDA—long rec­og­nized as the pri­ma­ry reg­u­la­tor of phar­ma­ceu­ti­cal ad­ver­tis­ing—would adopt a price dis­clo­sure re­quire­ment us­ing au­thor­i­ty del­e­gat­ed by Con­gress in the FD­CA. But af­ter com­menters point­ed out that the FDA has long con­ced­ed the FD­CA does not au­tho­rize price dis­clo­sure man­dates, HHS aban­doned that course,” the suit says.


First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. Click here for more in­for­ma­tion.

So­cial im­age: Shut­ter­stock

Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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On a roll, Mer­ck blazes through a new seg­ment of the bio­mark­er trail

Merck has notched an approval for using Keytruda to treat a biomarker-based subset of first-line colorectal cancer patients with unresectable or metastatic tumors, as the pharma giant continues to find new niches for its blockbuster PD-1 star.

The OK is significant in a number of ways. Not only does it build on an accelerated approval for all tumors characterized as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); it also marks the first single treatment for colorectal cancer that doesn’t contain chemotherapy.

No­var­tis los­es biosim­i­lar ap­peal as court up­holds a 31-year mo­nop­oly by Am­gen's En­brel

A new court ruling has strengthened Amgen’s grip on the IP estate around Enbrel, keeping biosimilars of the autoimmune and inflammatory drug at bay until 2029.

Novartis, the patent challenger, isn’t throwing in the towel yet. In a statement noting the failed appeal, its generics division Sandoz noted its reviewing options, “including potential appeal to US Supreme Court.”

It’s been almost four years since the FDA approved Erelzi, Sandoz’s copycat version of Enbrel. While sales of the Pfizer-partnered drug in the US — the market Amgen is in charge of — have dipped slightly during that time, it remains a solid megablockbuster with 2019 revenue slightly above $5 billion.