Drug prices in ads: Sen­ate pass­es amend­ment

The Sen­ate spend­ing bill passed Thurs­day and with it an amend­ment from Sens. Richard Durbin (D-IL) and Chuck Grass­ley (R-IA) to re­quire pre­scrip­tion drug ad­ver­tise­ments to in­clude prices.

Richard Durbin

The move, part of an ef­fort to shine a light on phar­ma­ceu­ti­cal com­pa­nies’ high drug prices, pro­vides the US De­part­ment of Health and Hu­man Ser­vices (HHS) with $1 mil­lion to im­ple­ment rules re­quir­ing phar­ma­ceu­ti­cal com­pa­nies to list prices of their pre­scrip­tion drugs in di­rect-to-con­sumer (DTC) ad­ver­tise­ments.

Last year, the phar­ma­ceu­ti­cal in­dus­try spent more than $6 bil­lion in DTC ad­ver­tise­ments, and the av­er­age Amer­i­can sees nine DTC pre­scrip­tion drug ads each day, ac­cord­ing to Grass­ley. The text of the amend­ment reads: “A drug that is ad­ver­tised to con­sumers with­out the in­for­ma­tion re­quired by this sec­tion or its im­ple­ment­ing reg­u­la­tions shall be deemed to be mis­brand­ed.”

Chuck Grass­ley

Durbin, who not­ed phar­ma­ceu­ti­cal com­pa­nies were the on­ly ones op­posed to the amend­ment, said in a state­ment: “What Sen­a­tor Grass­ley and I want­ed to do is to give the Amer­i­can peo­ple more in­for­ma­tion about drug costs. More in­for­ma­tion gives trans­paren­cy to the trans­ac­tion, and will help give Amer­i­can con­sumers a break and start to slow down the sky­rock­et­ing cost of pre­scrip­tion drugs.”

But whether the prices in ads will fur­ther en­rage or con­fuse Amer­i­cans re­mains to be seen. Sim­i­lar­ly, whether com­pa­nies will de­cide to ad­ver­tise dif­fer­ent prod­ucts based on price re­mains to be seen. The spon­sors of the amend­ment have yet to say whether the ads will use list prices or re­bate-re­duced prices, but they have linked their amend­ment to a new­ly pro­posed rule­mak­ing on trans­paren­cy.

Ear­li­er this week, the Cen­ters for Medicare and Med­ic­aid Ser­vices (CMS) sent for re­view a pro­posed rule­mak­ing ti­tled “Reg­u­la­tion to Re­quire Drug Pric­ing Trans­paren­cy” — though the text of the rule­mak­ing has not been made pub­lic. CMS cur­rent­ly of­fers drug spend­ing dash­boards, with in­for­ma­tion on Medicare Part B and D pro­grams as well as Med­ic­aid.

Ear­li­er this month, CMS al­so an­nounced plans to be­gin us­ing what’s called step ther­a­py to try to low­er the spend on Part B drugs by about 20% in Medicare Ad­van­tage plans. The an­nounce­ments are be­gin­ning to add up to a wider ef­fort, in­clud­ing the FDA’s gener­ic drug ap­provals, to bring down the prices of phar­ma­ceu­ti­cals. But whether the moves ac­tu­al­ly bring down prices re­mains to be seen.

Rachel Sachs, an as­sis­tant pro­fes­sor of law at Wash­ing­ton Uni­ver­si­ty in St. Louis, told Fo­cus: “Sec­re­tary Azar has de­cried the use of po­lit­i­cal ‘gim­micks’ that wouldn’t have an ef­fect on the prob­lem, but the ad­min­is­tra­tion has not yet ex­plained pub­licly how they think in­clud­ing prices in di­rect-to-con­sumer ad­ver­tise­ments will lead to drug com­pa­nies choos­ing to low­er their prices.”


First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion.

Author

Zachary Brennan

managing editor, RAPS

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

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The standard for-profit model in drug development is straightforward. Spend millions, even billions, to develop a medicine from scratch. The return on investment (and ideally a tidy profit) comes via volume and/or price, depending on the disease. But the string of big pharma exits and slew of biotech bankruptcies indicate that the model is sorely flawed when it comes to antibiotics.

The industry players contributing to the arsenal of antimicrobials are fast dwindling, and the pipeline for new antibiotics is embarrassingly sparse, the WHO has warned. Drugmakers are enticed by greener pastures, compared to the long, arduous and expensive path to antibiotic approval that offers little financial gain as treatments are typically priced cheaply, and often lose potency over time as microbes grow resistant to them.

Joe Jimenez, Getty

Ex-No­var­tis CEO Joe Jimenez is tak­ing an­oth­er crack at open­ing a new chap­ter in his ca­reer — and that in­cludes a new board seat and a $250M start­up

Joe Jimenez is back.

The ex-CEO of Novartis has taken a board seat on Century Therapeutics, the Versant and Bayer-backed startup focused on coming up with a brand new twist on cell therapies for cancer — a field where Jimenez made his mark backing the first personalized CAR-T approved for use.

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Amber Saltzman (Ohana)

Flag­ship's first ven­ture of 2020 is out, and it's all about sperm

A couple years ago, Amber Salzman got a call as she was returning East full-time after a two-year stint running a gene therapy company in California.

It was from someone at Flagship Pioneering, the deep-pocketed biotech venture firm. They had a new company with a new way of thinking about sperm. It had been incubating for over a year, and now they wanted her to run it.

“It exactly fit,” Salzman told Endpoints News. “I just thought I had to do something.”

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Pfizer trimmed a group of 3 R&D programs using their PD-L1 Bavencio — partnered with Merck KGaA — in their latest pipeline cull.

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In­cyte scores much need­ed PhI­II suc­cess — and of course it’s de­liv­ered by rux­oli­tinib

Incyte’s efforts to breathe a second life into ruxolitinib — its JAK inhibitor sold in pill form as Jakafi — has been greeted with clear, if preliminary and unsurprising, Phase III success.

Topline data from the TRuE-AD2 cements ruxolitinib’s foundational importance for Incyte, and gives analysts hope that there might yet be room for growth in a pipeline that’s suffered multiple R&D setbacks.

The FTC and New York state ac­cuse Mar­tin Shkre­li of run­ning a drug mo­nop­oly. They plan to squash it — and per­ma­nent­ly ex­ile him

Pharma bro Martin Shkreli was jailed, publicly pilloried and forced to confront some lawmakers in Washington riled by his move to take an old generic and move the price from $17.50 per pill to $750. But through 4 years of controversy and public revulsion, his company never backed away from the price — left uncontrolled by a laissez faire federal policy on a drug’s cost.

Now the FTC and the state of New York plan to pry his fingers off the drug once and for all and open it up to some cheap competition. And their lawsuit is asking that Shkreli — with several years left on his prison sentence — be banned permanently from the pharma industry.

UP­DAT­ED: Ac­celeron res­ur­rects block­buster hopes for so­tater­cept with pos­i­tive PhII — and shares rock­et up

Acceleron $XLRN says that its first major trial readout of 2020 is a success.

In a Phase II study of 106 patients with pulmonary arterial hypertension (PAH), Acceleron’s experimental drug sotatercept hit its primary endpoint: a significant reduction in pulmonary vascular resistance. The drug also met three different secondary endpoints, including the 6-minute walking test.

“We’re thrilled to report such positive topline results from the PULSAR trial,” Acceleron CEO Habib Dable said in a statement. The company said in a conference call they plan on discussing a Phase III trial design with regulators.

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Patrik Jonsson, the president of Lilly Bio-Medicines

Who knew? Der­mi­ra’s board kept watch as its stock price tracked Eli Lil­ly’s se­cret bid­ding on a $1.1B buy­out

In just 8 days, from December 6 to December 14, the stock jumped from $7.88 to $12.70 — just under the initial $13 bid. There was no hard news about the company that would explain a rise like that tracking closely to the bid offer, raising the obvious question of whether insider info has leaked out to traders.

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