PhRMA at­tacks New Mex­i­co’s ‘short on de­tail’ plan for Cana­di­an drug im­ports

In­dus­try group PhRMA con­tin­ues to fight a Trump-era fi­nal rule to al­low drug im­ports from Cana­da as the lob­by­ing group has now pe­ti­tioned the FDA to re­ject New Mex­i­co’s im­port plan be­cause of miss­ing de­tails that may make the im­port­ed drugs un­safe and not cost-ef­fec­tive.

The ap­pli­ca­tion “pro­vides scant in­di­ca­tion that the pro­posed SIP [Sec­tion 804 Im­por­ta­tion Pro­gram] will lead to any—let alone sig­nif­i­cant—re­duc­tion in cost to con­sumers,” PhRMA said in its pe­ti­tion.

The in­dus­try lob­by­ing group called on the FDA to re­ject the ap­pli­ca­tion, not­ing that it’s in­com­plete be­cause it fails to iden­ti­fy a for­eign sell­er, im­porter, or FDA-reg­is­tered repack­ager or re­la­bel­er for the drugs to be im­port­ed, and it pro­vides on­ly a ten­ta­tive list of drugs.

“New Mex­i­co sub­mit­ted a pro­pos­al so short on de­tail that FDA can­not as­sess whether the safe­ty or cost cri­te­ria can be met,” PhRMA said.

The lob­by­ing group in Jan­u­ary al­so sought to block Flori­da’s drug im­port plan via an FDA pe­ti­tion, claim­ing it would “jeop­ar­dize pa­tient safe­ty.” And the group has filed a law­suit to stop the fi­nal rule, ex­plain­ing that it could ex­pose pa­tients to risks as­so­ci­at­ed with un­ap­proved, mis­brand­ed, and adul­ter­at­ed drugs.

“The Biden Ad­min­is­tra­tion has un­til the end of the month to re­spond to PhRMA’s com­plaint,” Rachel Sachs, pro­fes­sor of law at Wash­ing­ton Uni­ver­si­ty School of Law, ex­plained to End­points News. “But the rule hasn’t been en­joined – no court or­der is stop­ping the FDA from ap­prov­ing any sub­mit­ted plans. How­ev­er, the plans them­selves may not be suf­fi­cient to mer­it ap­proval. PhRMA’s com­ment on New Mex­i­co’s plan notes that the state has not iden­ti­fied a For­eign Sell­er – but the fi­nal rule ex­plic­it­ly per­mit­ted states to sub­mit pro­pos­als with­out do­ing so, giv­ing them six ad­di­tion­al months to iden­ti­fy a For­eign Sell­er, af­ter which the FDA could de­ny the pro­pos­al.”

Even with a for­eign sell­er, PhRMA al­so rais­es con­cerns about New Mex­i­co’s abil­i­ty to en­sure its plan saves mon­ey for con­sumers, not­ing that the ap­pli­ca­tion of­fers “on­ly the rough­est back-of-the-en­ve­lope math (based large­ly on spend­ing by health plans, not in­di­vid­ual con­sumers) to sup­port its claims that im­por­ta­tion would re­duce the cost of cov­ered prod­ucts to New Mex­i­co con­sumers.” For in­stance, the plan “ig­nores sub­stan­tial start-up and ad­min­is­tra­tive costs which will lim­it the State’s cost sav­ings or elim­i­nate any sav­ings en­tire­ly,” PhRMA says.

The ap­pli­ca­tion al­so of­fers on­ly a pre­lim­i­nary list of 40 drugs, in­clud­ing 7 to treat HIV/AIDS, and says that the state will con­duct two more rounds of re-as­sess­ments of drugs to un­der­stand whether op­er­a­tional con­sid­er­a­tions weigh against any of the im­ports.

“FDA can­not as­sess whether the safe­ty or cost cri­te­ria can plau­si­bly be met with­out know­ing the iden­ti­ty of piv­otal sup­ply chain par­tic­i­pants or the drugs to be im­port­ed,” PhRMA ex­plains.

The group al­so notes that the 7 HIV/AIDS drugs on the ini­tial list must be stored at a tem­per­a­ture that does not ex­ceed 30 de­grees Centi­grade. But New Mex­i­co’s ap­pli­ca­tion pro­vides “no guide­lines for en­sur­ing that each sup­ply chain par­tic­i­pant com­plies with the stor­age in­struc­tions in­clud­ed in each drug’s la­bel­ing.”

New Mex­i­co’s ap­pli­ca­tion con­cludes that con­sumers would save about $9.8 mil­lion per year (or $6 mil­lion if the HIV/AIDS drugs are ex­clud­ed) be­cause of the im­ports. But PhRMA notes that pay­ers and phar­ma­cy ben­e­fit man­agers “are not ob­lig­at­ed to re­duce pre­mi­ums or co­pay­ments in re­sponse to im­por­ta­tion, and thus there is no guar­an­tee that con­sumers will see any sav­ings at all.”

And PhRMA is not alone in its push to halt any drug im­ports from Cana­da be­fore the ship­ments start. Be­gin­ning late last No­vem­ber, Cana­da an­nounced that cer­tain drugs in­tend­ed for its mar­ket are now pro­hib­it­ed from be­ing dis­trib­uted for con­sump­tion out­side of Cana­da if that sale would cause or wors­en a drug short­age.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Ap­peals court puts the fi­nal nail in the cof­fin for Tec­fidera patent, adding to Bio­gen's bur­geon­ing set­backs

In another setback for Biogen, the big biotech lost its appeal to revive a patent for the once-blockbuster drug Tecfidera, marking a likely conclusion to the case.

The US Court of Appeals for the Federal Circuit issued the ruling Tuesday morning, saying Biogen failed to satisfy the “written description” requirement for patent law. As a result, Mylan-turned-Viatris will be able to sell its multiple sclerosis generic without fear of infringement and Biogen will have to find a new revenue driver elsewhere.

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

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After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).

The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.

FDA can­cels ODAC meet­ing this week to re­view two more dan­gling ac­cel­er­at­ed ap­provals — but won't ex­plain why

The FDA’s Oncologic Drugs Advisory Committee has decided to cancel a planned meeting on Thursday to discuss two cancer drugs that previously won accelerated approvals but failed to confirm clinical benefit in required follow-up trials or have taken a long time to finish those trials.

The FDA said in a statement that the meeting “is no longer needed” but did not offer further detail on why exactly it was canceled, telling Endpoints News to contact the companies. Attempts to contact both Secura Bio and Acrotech went unreturned. The companies may have decided to pull these treatments from the market, or they’ve come to new agreements with the agency on their confirmatory trials.

Viatris employees rang the Nasdaq bell on Nov. 16, marking the one-year anniversary of the merged Mylan and Pfizer Upjohn company

Start­ing from scratch: Vi­a­tris’ new brand, cul­ture set­tle in 1 year af­ter My­lan, Up­john merg­er

When Mylan and Pfizer’s Upjohn unit merged last year, headlines touted the $12 billion deal and newly named Viatris as the largest generic drugmaker in the world. But that’s not exactly how the company wanted to be known.

So Viatris — which rhymes with Beatrice — began working to create a new brand and culture from scratch around its distinct mix of old pharma blockbusters while layering in a massive portfolio of generic and OTC meds and building up a fresh pipeline of biosimilars.

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How to use reg­istry da­ta to sup­port FDA de­ci­sion mak­ing: Agency ex­plains in new guid­ance

Drugmakers looking to design a new registry or use an existing one to support a regulatory decision on a drug’s effectiveness or safety will need to consult with a new draft guidance released Monday by the FDA.

The agency’s reliance on registry data for regulatory decisions dates back more than two decades, at least, as in 1998 Bayer won approval for its anticoagulant Refludan (withdrawn from the market in 2013 for commercial reasons) based in part on a historical control group pulled from a registry.