Sen. Bernie Sanders (Michael Brochstein/Sipa via AP Images)

‘A mess across the board’: Sen­ate com­mit­tee kicks off talks on drug pric­ing re­forms

The US is still the on­ly coun­try in the world that doesn’t ne­go­ti­ate phar­ma­ceu­ti­cal prices across the board, ex­perts told a Sen­ate com­mit­tee on Tues­day, but how ex­act­ly to fix that re­mains un­clear and few of the so­lu­tions dis­cussed will sur­prise any­one watch­ing the pric­ing de­bate play out over the last decade.

Set­ting the tone for the hear­ing, which fea­tured com­ments from a type 1 di­a­betes pa­tient, Elia Spates, who has seen her in­sulin costs triple over about a decade, Sen. Bernie Sanders (I-VT) honed in on the fact that Spates is not alone, and 1 out of 5 Amer­i­cans could not af­ford their pre­scrip­tion drugs last year.

“How crazy is that?” he asked rhetor­i­cal­ly.

Sanders re­cent­ly in­tro­duced three bills co-spon­sored by oth­er De­moc­rats to tack­le drug prices, of­fer­ing re­cy­cled ideas on peg­ging the price of drugs in the US to for­eign coun­tries’ prices (an idea al­so float­ed by for­mer Pres­i­dent Trump), al­low­ing HHS to ne­go­ti­ate drug prices un­der Medicare Part D (which has been de­bat­ed for more than a decade), and al­low­ing drug im­ports from Cana­da (which is al­ready on­go­ing).

Aaron Kessel­heim

Ex­perts at the hear­ing of­fered their own so­lu­tions for what should be done. Aaron Kessel­heim, pro­fes­sor of med­i­cine at Har­vard Med­ical School, ex­plained a more de­tailed ap­proach – call­ing for the US to eval­u­ate new drugs up­front based on a re­view of their clin­i­cal ben­e­fits and then al­low­ing the gov­ern­ment to ne­go­ti­ate prices based on their find­ings. He al­so called for the fed­er­al gov­ern­ment to crack down on price in­creas­es “well be­yond in­fla­tion,” and to en­sure that patents for new med­i­cines are le­git­i­mate.

“The phar­ma­ceu­ti­cal lob­by is large and well-fund­ed and will ar­gue that any re­duc­tion in rev­enues will harm in­no­va­tion. But most drugs ap­proved each year are not tru­ly in­no­v­a­tive and in a re­view of 2017 new ap­provals, on­ly a mi­nor­i­ty of those re­viewed by in­de­pen­dent ex­pert bod­ies of­fered more than min­i­mal clin­i­cal ad­van­tages over avail­able treat­ments,” he said in his writ­ten tes­ti­mo­ny.

But De­moc­rats hold a ra­zor-thin ma­jor­i­ty in the Sen­ate, mean­ing Re­pub­li­cans will need to be won over to get a stand­alone bill passed.

Alex Law­son, the ex­ec­u­tive di­rec­tor of So­cial Se­cu­ri­ty Works who’s been work­ing be­hind the scenes on drug pric­ing on Capi­tol Hill, told End­points News in a phone in­ter­view that he thinks ma­jor drug pric­ing re­forms will be tagged on­to an­oth­er in­fra­struc­ture bill, which has to hap­pen be­fore Sep­tem­ber, be­cause it would be im­pos­si­ble for the De­moc­rats to get 60 votes to pass a stand­alone bill.

Alex Law­son

“I think ne­go­ti­a­tion will be the heart of what it is – some form of ne­go­ti­a­tion,” he said. “In­dus­try thinks that they won’t have to deal with ex­tra­or­di­nar­i­ly high drug prices be­cause the vac­cines are turn­ing the cor­ner on this pan­dem­ic, and I think they’re sore­ly mis­tak­en.”

The idea of hav­ing the sav­ings from high drug prices pay for new in­fra­struc­ture is al­so at­trac­tive to De­moc­rats, he not­ed.

But some Re­pub­li­cans, hes­i­tant to harm a biotech ecosys­tem that is flour­ish­ing and has brought the US mul­ti­ple Covid-19 vac­cines in less than a year, fo­cused their com­ments Tues­day on ways to re­duce pa­tients’ out-of-pock­et ex­pens­es with­out hurt­ing drug­mak­ers’ bot­tom lines, as well as ways to in­crease trans­paren­cy and en­sure re­bates end up in pa­tients’ pock­ets.

Louisiana Re­pub­li­can Bill Cas­sidy al­so ex­pressed con­cerns about the fed­er­al gov­ern­ment set­ting drug prices uni­lat­er­al­ly, which could have a chill­ing ef­fect on VCs that fund the work that takes a com­pound from the bench to a tri­al, and are ex­pect­ing a re­turn on their in­vest­ments.

Re­pub­li­can Su­san Collins of Maine not­ed she hopes Con­gress can find com­mon ground on the is­sue of drug prices be­cause “when a doc­tor pre­scribes a need­ed med­ica­tion, an in­sur­mount­able is­sue should not be the cost.”

In­di­ana Re­pub­li­can Mike Braun, how­ev­er, went in the oth­er di­rec­tion and in­di­cat­ed a will­ing­ness to let the gov­ern­ment step in, call­ing the cur­rent drug pric­ing sys­tem “a mess across the board.” He al­so said of the phar­ma­ceu­ti­cal in­dus­try, “There is no oth­er sec­tor of our econ­o­my that has less trans­paren­cy, less com­pe­ti­tion and more bar­ri­ers to en­try and dis­en­gaged con­sumers. One al­ter­na­tive is to bring in gov­ern­ment.”

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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Sean Ianchulev, Eyenovia CEO and CMO

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

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Robert Califf (Pablo Martinez Monsivais, AP Images, File)

As buzz on Califf FDA nom heats up, in­dus­try and agency in­sid­ers of­fer a strong nod for the ‘per­fect’ choice

For once in this long, dramatic road to finding a new FDA commissioner, there’s been some continuity. Both CNN and Politico reported this weekend that Rob Califf met with President Biden to discuss the permanent commish role, following earlier news broken by the Washington Post that all signs point to Califf.

Although there may be a few Democrats who continue to grandstand about the dangers of COI (Califf has worked for Verily, sits on the board of Centessa Pharmaceuticals, and has other ties to industry research), with the pandemic ongoing and the need for some kind of continuity at FDA mounting, Califf is likely to meet the same fate as when he first won Senate confirmation in 2016, by a vote of 89-4 — Bernie Sanders and 6 others didn’t vote.

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AstraZeneca CEO Pascal Soriot (Raphael Lafargue/Abaca/Sipa USA)

A com­bo of As­traZeneca's Imfinzi and chemo wins where oth­ers have failed in piv­otal bil­iary tract test

Looking to run with the big dogs in the PD-(L)1 class, AstraZeneca’s Imfinzi has a tall hill to climb to compete in an increasingly bustling market. An aggressive combo strategy for the drug has paid off so far, and now AstraZeneca is adding another notch to its belt.

A combo of Imfinzi (durvalumab) and chemotherapy significantly extended the lives of first-line patients with advanced biliary tract cancer over chemo alone, according to topline results from the Phase III TOPAZ-1 study revealed Monday.

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UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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Sim­mer­ing feud be­tween blue­bird and a ri­val con­tin­ues with al­le­ga­tions of patent fraud

Bluebird bio was hit with a patent infringement lawsuit last week from a Chicago-based biotech it has had an ongoing beef with calling for $2 billion to help cure the “irreparable harm” caused by alleged willful infringement.

Bluebird bio is facing a lawsuit from Errant Gene Therapeutics for violating patent law in two instances, the company says.

The suit alleges that bluebird infringed the rights of EGT’s recombinant vectors used in the gene therapy treatment of rare diseases such as sickle cell disease and beta thalassemia for its drugs Zynteglo and LentiGlobin. EGT has an exclusive license from the Memorial Sloan Kettering Cancer Center to patents titled “vector encoding human global gene and use thereof in treatment of Hemoglobinopathies.”

Just as first Lu­cen­tis biosim­i­lar wins ap­proval, Roche snags an OK for an eas­i­er route of ad­min­is­tra­tion

It’s been a month since the FDA cleared the first biosimilar to Roche’s blockbuster wet age-related macular degeneration (AMD) drug ranibizumab. But the pharma giant isn’t going down without a fight.

Roche’s Genentech got approval on Friday for a new ranibizumab administration route that will allow wet AMD patients to ditch their current monthly injections and opt instead for as few as twice-annual treatments.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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