Donald Trump (AP Images)

Trump ups the stakes with 'grand­dad­dy of them al­l' drug pric­ing ex­ec­u­tive or­der. But he could be run­ning out of time

When Pres­i­dent Don­ald Trump signed four ex­ec­u­tive or­ders in late Ju­ly aim­ing at low­er­ing drug prices, de­tails of the most con­tro­ver­sial — “the grand­dad­dy of them all,” ac­cord­ing to Trump — were con­spic­u­ous­ly miss­ing.

Al­most two months lat­er, the text is fi­nal­ly here. And it’s al­ready been ex­pand­ed.

The EO in­structs Health and Hu­man Ser­vices Sec­re­tary Alex Azar to test a pay­ment mod­el in which Medicare would pay no more than the “most-fa­vored-na­tion price” for doc­tor and out­pa­tient ser­vices (Part B) as well as pre­scrip­tion drugs (Part D). While rule-mak­ing plans were al­ready in place for the for­mer, reg­u­la­tions for the lat­ter re­quire a sep­a­rate, new process.

Which means it may not be im­ple­ment­ed any time soon. But that doesn’t stop in­dus­try ad­vo­cates from blast­ing the or­der with ur­gency.

PhRMA had re­port­ed­ly sub­mit­ted a coun­terof­fer in Au­gust to the White House af­ter Trump asked them to pro­pose an al­ter­na­tive. It would have ef­fec­tive­ly cut Part B prices by 10%, ver­sus 30% as the ad­min­is­tra­tion was shoot­ing for, per Politi­co.

Stephen Ubl

Echo­ing his pre­vi­ous com­ments, PhRMA pres­i­dent Stephen Ubl calls the most-fa­vored na­tion pol­i­cy “ir­re­spon­si­ble and un­work­able,” as it dou­bles down on “a reck­less at­tack on the very com­pa­nies work­ing around the clock to beat Covid-19.”

“What’s worse is that they are now ex­pand­ing the pol­i­cy to in­clude med­i­cines in both Medicare Part B and Part D, an over­reach that fur­ther threat­ens Amer­i­ca’s in­no­va­tion lead­er­ship and puts ac­cess to med­i­cines for tens of mil­lions of se­niors at risk,” its state­ment reads. “Rather than em­u­lat­ing coun­tries that al­low politi­cians to ar­bi­trar­i­ly de­cide what med­i­cines are worth and what dis­eases are worth in­vest­ing in, we should use ex­ist­ing trade en­force­ment tools to pre­vent them from free­load­ing off Amer­i­can in­no­va­tion.”

Sim­i­lar­ly, BIO’s Michelle Mc­Mur­ry-Heath de­scribed the move to move for­ward with the plans to es­sen­tial­ly “im­port for­eign price con­trols” as “dumb­found­ing.”

Michelle Mc­Mur­ry-Heath

“That is why we will use every tool avail­able — in­clud­ing le­gal ac­tion if nec­es­sary — to fight this risky for­eign price con­trol scheme,” she said.

Al­though dif­fer­ent in name, the idea of ref­er­enc­ing what oth­er coun­tries, many of whom have sin­gle-pay­er health­care sys­tems and ag­gres­sive ne­go­ti­a­tion tac­tics, pay in or­der to bring down Amer­i­can drug prices dates back at least to 2018. The Cen­ters for Medicare & Med­ic­aid Ser­vices be­gan work­ing on a pro­posed mod­el dubbed the in­ter­na­tion­al pric­ing in­dex fo­cused around Medicare Part B. A sub­se­quent health­care bill passed by the De­mo­c­rat-con­trolled House in­clud­ed a pro­vi­sion that would em­pow­er HHS to ne­go­ti­ate prices for 250 pre­scrip­tion drugs based on the same in­dex. The prices would ap­ply to gov­ern­ment and com­mer­cial mar­kets alike.

Big Phar­ma lead­ers and small biotech in­vestors alike have long op­posed the pro­pos­al in its var­i­ous in­car­na­tions, cit­ing a fore­cast re­duc­tion in new med­i­cines. They were joined by Sen­ate Re­pub­li­cans, who had draft­ed their own pric­ing bill fo­cused on out-of-pock­et costs.

They may not be alone in this par­tic­u­lar fight, Michael Ganio, the se­nior di­rec­tor of phar­ma­cy prac­tice and qual­i­ty at the Amer­i­can So­ci­ety of Health-Sys­tem Phar­ma­cists, said on Twit­ter.

Yet again, with just a few months left in his first term, Trump’s last-ditch ef­fort to tack­le drug prices still faces sig­nif­i­cant hur­dles that can stretch be­yond the cur­rent term, not­ed Rachel Sachs, as­so­ciate pro­fes­sor of law at Wash­ing­ton Uni­ver­si­ty in St. Louis.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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Anthony Fauci (AP Images)

A press of­fi­cer at An­tho­ny Fau­ci’s NI­AID was un­masked as a hard-right Covid troll. He just re­tired to­day

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.

Donald Trump, AP

Covid-19 roundup: Trump sug­gests Pfiz­er vac­cine could be first ap­proved; VBI Vac­cines inks de­vel­op­ment deal with Cana­da

President Donald Trump commented Monday morning that Pfizer’s Covid-19 vaccine candidate could be the first to win approval by regulators.

During an interview on a Fox News’ morning show, the president said Pfizer was doing “very well” when asked which candidate could be approved, according to a Reuters report. He added that J&J could follow up afterward, saying “they’ll probably be a little later.”

Is­raeli biotech rais­es $57M to go where cur­rent BRAF in­hibitors can't, with back­ing from No­var­tis, SR One

For the blockbuster potential of Novartis’ Tafinlar and Pfizer’s Braftovi, all the BRAF inhibitors on the market so far only target V600 mutations — which accounts for roughly 50% of patients.

Israeli biotech Novellus now has $57 million to develop a drug that they say can help the other 50% who have everything else.

The Series C will fund a Phase II trial for PLX-8394, a “paradox breaker” that could block RAF without activating MAPK signaling. In a Phase I trial, a patient with a BRAF fusion saw their tumor go away after taking the drug, allowing Novellus to hit the ground running.