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.

New EO af­fects CMS pay­ment (drug re­im­burse­ment), not drug prices. So where does that leave hos­pi­tals and phar­ma­cies who ac­tu­al­ly pay for the drugs? Looks like they are the ones who will be pay­ing for the dif­fer­ence un­less they can ne­go­ti­ate prices down. https://t.co/ovzkyhm­Nu2

— Michael Ganio, Phar­mD, MS (@mganio_ASHP) Sep­tem­ber 13, 2020

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.

As a re­minder, in De­cem­ber 2019, the House (led by the De­mo­c­ra­t­ic cau­cus) passed a bill that would've used in­ter­na­tion­al ref­er­ence pric­ing to low­er the price of drugs in Medicare. Trump threat­ened to ve­to that bill. https://t.co/eREC­N­qLzTD https://t.co/Vu­oSo­jDb4f

— Rachel Sachs (@RE­Sachs) Sep­tem­ber 13, 2020

Jazz CEO Bruce Cozadd didn’t beat around the bush.

In his first video meeting with GW Pharma chief Justin Gover last July 8, he offered to pay $172 a share to get the company, which had beaten the odds in getting its remarkable cannabinoid drug Epidiolex across the regulatory finish line for epilepsy. GW’s stock closed at $129 that day.

Cozadd had already done his homework on the financing to make sure he could swing it the way he wanted. He just needed to do some due diligence before making the non-binding bid firm.

Actemra’s failure to hit the primary endpoint in a Phase III study didn’t stop the FDA from granting Roche priority review. And it’s certainly not standing in the way of a sixth approval for Roche’s IL-6 drug.

Regulators have cleared Actemra, or tocilizumab, for systemic sclerosis-associated interstitial lung disease in adult patients. Roche’s big Genentech subsidiary notes that it is the first biologic approved for this rare disease.