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.

If PhRMA and its two al­lies, the Part­ner­ship for Safe Med­i­cines and the Coun­cil for Af­ford­able Health Cov­er­age, pre­vail, no states will ever get an im­por­ta­tion plan through.

If any­one still re­mem­bers, a month be­fore the elec­tion the agency com­plet­ed a rule­mak­ing process that opened the door for phar­ma­cists and whole­salers to im­port. But they must set up spe­cial pro­grams, ap­ply for it and make sure the drugs meets cer­tain re­quire­ments in­clud­ing sig­nif­i­cant cost re­duc­tions to the cus­tomer. The prod­ucts must al­so be re­la­beled and test­ed.

For PhRMA, the HHS is vi­o­lat­ing fed­er­al law and flout­ing key pro­tec­tions of the Fed­er­al Food, Drug, and Cos­met­ic Act.

“It is par­tic­u­lar­ly dis­turb­ing that the ad­min­is­tra­tion is punt­ing the re­spon­si­bil­i­ty for demon­strat­ing safe­ty and cost sav­ings to state gov­ern­ments de­spite the clear re­quire­ment un­der fed­er­al law that the Sec­re­tary of HHS must cer­ti­fy that im­port­ed drugs both pose no ad­di­tion­al risk to pub­lic safe­ty and will lead to sig­nif­i­cant sav­ings for the Amer­i­can con­sumer,” James Stansel, the or­ga­ni­za­tion’s gen­er­al coun­sel, said in a state­ment.

Specif­i­cal­ly, its lit­i­ga­tion al­leges that by out­sourc­ing the gate-keep­ing role to state gov­ern­ments, HHS Sec­re­tary Alex Azar’s cer­ti­fi­ca­tion is con­trary to Sec­tion 804 of the FD­CA. The sec­tion stip­u­lates that HHS can on­ly per­mit im­por­ta­tion if it cer­ti­fies to Con­gress that the im­ple­men­ta­tion would pose no ad­di­tion­al pub­lic health risk and re­sult in a sig­nif­i­cant re­duc­tion.

Cit­ing “well-doc­u­ment­ed safe­ty con­cerns re­gard­ing im­por­ta­tion” — a long-run­ning mes­sage that fea­tures promi­nent­ly on its web­page ded­i­cat­ed to the top­ic — PhRMA piled on the im­ple­men­ta­tion of the pro­gram as a “false promise.”

The whole idea has been un­pop­u­lar among in­dus­try ex­ecs, many of whom ar­gue im­por­ta­tion won’t work but might hurt the in­dus­try’s in­cen­tives.

Even be­fore the law­suit, it wasn’t clear how wide­spread drug im­por­ta­tion could be. Flori­da failed to at­tract a sin­gle bid­der for its $30 mil­lion con­tract to set up and op­er­ate a pro­gram for the state. Cana­da — where the cheap­er drugs would the­o­ret­i­cal­ly come from — has vowed to en­sure there won’t be a short­age of drugs with­in its bor­ders, which could mean stop­ping its own phar­ma­cies from ex­port­ing the med­i­cines.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

As­traZeneca caps PD-L1/CT­LA-4/chemo com­bo come­back with OS win. Is treme­li­mum­ab fi­nal­ly ready for ap­proval?

AstraZeneca’s closely-watched POSEIDON study continues to be the rare bright spot in its push for an in-house PD-L1/CTLA-4 combo.

Combining Imfinzi and tremelimumab with physicians’ choice of chemotherapy helped patients with stage IV non-small cell lung cancer live longer, the company reported — marking the first time the still-experimental tremelimumab has demonstrated an OS benefit.

For AstraZeneca and CEO Pascal Soriot, the positive readout — which is devoid of numbers — offers much-needed validation for the big bet they made on Imfinzi plus tremelimumab, after the PD-L1/CTLA-4 regimen failed multiple trials in head and neck cancer as well as lung cancer.

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Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

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Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Drug pric­ing watch­dog joins the cho­rus of crit­ics on Bio­gen's ad­u­canum­ab: What about charg­ing $2,560 per year?

As if Biogen’s aducanumab isn’t controversial enough, the researchers at drug pricing watchdog ICER have drawn up the contours of a new debate: If the therapy does get approved for Alzheimer’s by June, what price should it command?

Their answer: At most $8,290 per year — and perhaps as little as $2,560.

Even at the top of the range, the proposed price is a fraction of the $50,000 that Wall Street has reportedly come to expect (although RBC analyst Brian Abrahams puts the consensus figure at $11.5K). With critics, including experts on the FDA’s advisory committee, making their fierce opposition to aducanumab’s approval loud and clear, the pricing pressure adds one extra wrinkle Biogen CEO Michel Vounatsos doesn’t need as he orders full-steam preparation for a launch.

Biden ad­min­is­tra­tion backs a po­lar­iz­ing pro­pos­al to waive IP for all Covid-19 vac­cines

In a surprise U-turn, the Biden administration said Wednesday that it will support a proposal at the World Trade Organization to temporarily waive intellectual property protections on Covid-19 vaccines.

The proposal, backed by South Africa and India at the WTO, seeks to help developing countries with limited vaccine supplies. The US and Europe historically opposed the proposal, saying IP should be protected because it incentivizes new drug and vaccine development.

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FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

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