In land­mark hear­ing, drug­mak­ers and law­mak­ers agree that US pol­i­cy on drug pric­ing is ripe for change — but there's no con­sen­sus on much else

Sev­en big phar­ma ex­ec­u­tives faced a pla­toon of US sen­a­tors on Tues­day, ex­pect­ing a dress­ing down on the in­dus­try’s track record of re­lent­less price hikes that has sparked bi­par­ti­san furor — but were in­stead treat­ed to a con­sci­en­tious de­bate, high on con­cern and low on con­tention.

Mat­ters kicked off with Sen­a­tor Ron Wyden ad­mon­ish­ing every bio­phar­ma rep­re­sen­ta­tive for their com­pa­ny’s tac­tics, in­clud­ing Ab­b­Vie pro­tect­ing its $18-bil­lion-a-year Hu­mi­ra from gener­ics like “Gol­lum with his ring,” and Pfiz­er for mak­ing the “emp­ti­est pric­ing ges­ture” by press­ing pause on hikes un­der pres­sure from Pres­i­dent Don­ald Trump for a pe­ri­od on­ly to re­sume lat­er.

He gave way to pre­pared re­marks from the com­pa­ny rep­re­sen­ta­tives: Ab­b­Vie chief $AB­BV Richard Gon­za­lez; As­traZeneca $AZN chief Pas­cal So­ri­ot; Bris­tol-My­ers $BMY chief Gio­van­ni Caforio; J&J’s $JNJ Janssen head Jen­nifer Taubert; Mer­ck $MRK chief Ken Fra­zier; Pfiz­er’s $PFE chief Al­bert Bourla and Sanofi $SNY chief Olivi­er Brandi­court.

Un­sur­pris­ing­ly, each ex­ec­u­tive blamed high list prices on the mid­dle­men: PBMs and in­sur­ers, sug­gest­ing that while the mag­ni­tude of re­bates of­fered by them were in­creas­ing, those ben­e­fits were not be­ing ac­crued to the pa­tient in the form of co-pays.

Fra­zier — Mer­ck’s fire­brand chief and de-fac­to leader of the un­like­ly troop of pan­elists thanks to his le­gal ex­per­tise (Fra­zier served as Mer­ck’s chief coun­sel back when it was fight­ing a flood of Vioxx law­suits) — al­so un­der­scored the fact that the is­sue of pric­ing is sys­temic to the US health­care sys­tem, lament­ing that pa­tients are ex­pect­ed to pay on av­er­age 13% in drug co-pays, but on­ly 3% of hos­pi­tal costs. 

Ken­neth Fra­zier, Chair­man and Chief Ex­ec­u­tive Of­fi­cer at Mer­ck, tes­ti­fies be­fore the Sen­ate Fi­nance Com­mit­tee hear­ing on drug prices on Tues­day, Feb. 26, 2019 (AP Pho­to/Pablo Mar­tinez Mon­si­vais)

Click on the im­age to see the full-sized ver­sion


In gen­er­al, the drug­mak­ers voiced their sup­port for re­bate re­form. As­traZeneca’s So­ri­ot sug­gest­ed that on av­er­age, rough­ly 50% of his com­pa­ny’s list prices com­prise re­bates, and if they were to be dis­card­ed al­to­geth­er he would not be averse to cut­ting prices by the same mag­ni­tude. When asked point blank by more than one sen­a­tor about whether each ex­ec­u­tive would pledge to cut list prices if re­bates were elim­i­nat­ed, ex­ec­u­tives pro­posed cut­ting re­bates not just for Medicare but al­so on the com­mer­cial side to even the play­ing field for all drug man­u­fac­tur­ers, as suf­fi­cient in­cen­tive to low­er list prices.

An­oth­er so­lu­tion en­dorsed by the pan­el of drug­mak­ers was val­ue-based pric­ing.

Pfiz­er’s new­ly-mint­ed CEO Bourla told sen­a­tors he would pre­fer that the com­pa­ny be paid for “the heart at­tacks we pre­vent, and not the pills we sell.”  Al­though the con­cept is gain­ing trac­tion for new­er, high­er priced drugs, it has not uni­ver­sal­ly been adopt­ed. Mean­while, old­er drugs (in­clud­ing in­sulin that is sub­ject to fre­quent price hikes) are not in con­tention for such val­ue-based con­tracts.

Drug­mak­ers al­so ex­pressed en­thu­si­asm for shoring up biosim­i­lar and gener­ic com­pe­ti­tion in the Unit­ed States as a mech­a­nism to low­er drug prices.

Some pan­elists al­so en­dorsed the Cre­at­ing and Restor­ing Equal Ac­cess to Equiv­a­lent Sam­ples (CRE­ATES) Act — a bill de­signed to cre­ate a faster and more po­tent le­gal process for gener­ic man­u­fac­tur­ers to chal­lenge brand­ed drug­mak­ers that they claim are with­hold­ing drug sam­ples in or­der to ob­struct gener­ic com­pe­ti­tion. When sen­a­tors in­quired whether any of the drug­mak­ers at the hear­ing had any his­to­ry of block­ing drug sam­ples when to thwart copy­cat drug de­vel­op­ment, each de­clined that their com­pa­nies had en­gaged in any such prac­tices. But a cur­so­ry look at the FDA’s web­site sug­gests oth­er­wise.

The mood at the hear­ing was a mix­ture of cau­tious ad­mi­ra­tion for the in­dus­try for hav­ing de­vel­oped a pletho­ra of sci­en­tif­ic break­throughs, but in­cred­u­lous­ness that the Unit­ed States ef­fec­tive­ly shoul­ders the cost of in­no­va­tion, con­sid­er­ing oth­er West­ern in­dus­tri­al­ized na­tions — on av­er­age — pay low­er drug prices.

“Why are we a price tak­er, when we are the largest pur­chas­er?,” Sen­a­tor Bill Cas­sidy asked in one ex­change. An­oth­er sen­a­tor cit­ed sup­port for the Trump ad­min­is­tra­tion pro­pos­al to im­port drug prices from over­seas, but was im­me­di­ate­ly re­buffed by the drug­mak­ers who ar­gued that a num­ber of these na­tions do not ac­cept new med­i­cines due to their pric­ing poli­cies, of­ten re­strict­ing ac­cess or de­clin­ing to adopt them al­to­geth­er.

Al­though drug­mak­ers were asked whether their tax breaks — en­gi­neered by the Trump ad­min­is­tra­tion — had been used to cut prices, the phar­ma­ceu­ti­cal com­pa­nies large­ly ac­knowl­edged that the sav­ings had large­ly not been used in that fash­ion.

The main vil­lain of the hear­ing was Ab­b­Vie chief Gon­za­lez, who was per­sis­tent­ly called out for his com­pa­ny’s patent-ag­gres­sive ap­proach to pro­tect­ing their biggest, most lu­cra­tive as­set Hu­mi­ra — the world’s largest sell­ing drug whose main US patent ran out in 2016. Gon­za­lez’s main talk­ing point was that that while some Eu­ro­pean na­tions have bagged an 80% dis­count on Hu­mi­ra, the US price (and sales) is what keeps the com­pa­ny’s R&D en­gine hot.

Per­sis­tent ques­tions by one sen­a­tor to adopt Cost­co-style pric­ing — get­ting sales via vol­ume ver­sus pric­ing — got a tepid re­sponse from pan­elists. But, one pro­pos­al did whet pan­elist ap­petites. Sen­a­tor Shel­don White­house called out the bad ac­tors and “non-in­no­va­tors” of the in­dus­try (re­mem­ber Shkre­li, the poster boy of bad, smug biotech?) that buy off-patent drugs used in con­di­tions with few or no treat­ment op­tions and jack up their prices cre­at­ing a mo­nop­oly and hang­ing pa­tients who use these decades-old treat­ments out to dry. When we try to crack down against these ac­tors, White­house said, your lob­by­ists push­back. “Help us at least solve that prob­lem…turn off your lawyers and your lob­by­ists!” he said to the nod­ding heads of in­dus­try reps. “We will,” Fra­zier re­spond­ed.

Ear­li­er on, Sen­a­tor Bob Menen­dez made a thin­ly veiled threat to the crop of pan­elists be­fore him, sug­gest­ing that if drug­mak­ers were un­will­ing to rein in prices, “pol­i­cy­mak­ers are go­ing to do it for you.”  At the end of the pro­ceed­ings, the pan­elists large­ly agreed. The “gov­ern­ment has to step up and change the rules,” So­ri­ot said. Now there’s just the small mat­ter of fig­ur­ing out how to do that.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Jeffrey Nau, Oyster Point Pharma CEO

FDA OKs an in­haled ver­sion of smok­ing ces­sa­tion drug Chan­tix — for a com­mon eye dis­ease

Oyster Point Pharma now has its first FDA-approved product — Tyrvaya. And the biotech has taken a unique route to get there by using an old drug with a storied past.

The New Jersey biotech announced this morning that the FDA has approved their nasal spray product for dry eye disease on Friday — the first nasal spray to be approved for the disease. The product’s active ingredient is 0.03 mg of varenicline, also known as smoking cessation aid Chantix.

Sheldon Koenig, Esperion CEO

Es­pe­ri­on gets out the bud­get ax, chop­ping 170 staffers as its big drug launch sput­ters

Esperion’s executive team spent years insisting that they had found the sweet spot in the market for their cholesterol drug. But that strategy has soured badly, and after struggling to sell its heart disease pill for more than a year, the biotech says it will cut about 40% of its staff over the next few weeks.

The layoffs will take place across the board, from sales and marketing to R&D, CEO Sheldon Koenig told Endpoints News on Monday. While the chief executive declined to elaborate on how many employees will be affected, an SEC filing stated that approximately 170 staffers are on the chopping block.

Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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