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.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

PhRMA sues Trump gov­ern­ment over drug im­por­ta­tion rule — days be­fore it's set to be ef­fec­tive

Ever since President Donald Trump floated the idea of using state-sponsored importation to lower drug prices, PhRMA has made its opposition abundant. Not only is the proposal dangerous and futile,  but the trade group has also argued that it may even be illegal.

Now that the FDA has issued its final rule permitting states to bring certain drugs from Canada, PhRMA is taking the government to court — just a few days before the rule is slated to take effect.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

The flu virus (CDC)

Roche tacks on an­oth­er Xofluza in­di­ca­tion as flu sea­son meets pan­dem­ic

Xofluza was heralded as the first new flu drug in 20 years when it got the FDA OK back in 2018. But even so, Roche saw tough competition from cheaper Tamiflu generics that appeared to be nearly as — if not just as — effective.

Now, the pharma says the drug also can be used to prevent influenza after exposure, snagging a new approval and adding to Xofluza’s appeal as flu season meets the pandemic.

A poll sug­gests vac­cine da­ta boost­ed Pfiz­er's pub­lic im­age, but oth­er da­ta point to long road ahead

For much of the pharmaceutical industry, the pandemic presented an opportunity: to prove their value to the world and turn public opinion around on a business much of the country had come to disdain.

That theory — that helping pull the country from a pandemic could neutralize years of anger over high drug prices — was put to its biggest test this month, as three different drugmakers announced data from their Covid-19 vaccines, offering the first major evidence that industry-built inoculations could turn the tide of the outbreak in the US.

News brief­ing: Gilead part­ner Gala­pa­gos sells off CRO for $37M; Polyphor bags $3.3M from CF Foun­da­tion

Close Gilead ally Galapagos is selling off one of its contract research organizations to a Polish pharma company.

Galapagos has agreed to sell 100% of the outstanding shares in the CRO Fidelta to Selvita, in a deal worth roughly $37 million expected to close in the first week of January. The acquisition is expected to nearly double Selvita’s revenues, the company says, as well as expand its drug discovery efforts.