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.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roger Perl­mut­ter lines up deals, fresh fund­ing at Eikon; Sec­ond RSV vac­cine ap­proved; Sev­er­al biotechs flash­ing red; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As you come back to our website this weekend for ASCO news, don’t forget to check out our updated event lineup at BIO, which will cover everything from the current state of VC investing in biotech to top pharma R&D chiefs discussing how to make pipeline decisions.

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Roger Perlmutter, Eikon Therapeutics CEO

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Eikon Therapeutics announced three business development deals on Thursday, effectively dropping in a pipeline of cancer drugs alongside more than $100 million in fresh funding.

The Hayward, CA-based company has become one of biotech’s richest startups since its 2019 founding, having raised nearly $775 million. It’s developing a massive, automated research approach built around Nobel Prize-winning microscope science to peer inside cells and watch proteins in action. After its Series B last year, PitchBook reported a $3.02 billion valuation. And while CEO Roger Perlmutter declined to comment on that figure, he said its first tranche of nearly $106 million in Series C funding is a “meaningful step-up to our Series B valuation.”

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GSK pro­motes rou­tine im­mu­niza­tions for adults amid post-pan­dem­ic vac­cine back­slide

GSK launched a new initiative on Thursday and committed up to $1 million in grant funding to improve adult routine vaccination rates.

While the pandemic spotlight was trained on the race for novel Covid-19 vaccines, other routine vaccination rates plummeted, raising concerns that missed doses may put children and even some adults at risk of preventable diseases such as measles or shingles. The World Health Organization last year reported the largest drop in childhood vaccinations in roughly three decades.

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Tammie Denyse speaks up about Black women and breast cancer inequity in Gilead's first TikTok campaign. (Gilead Sciences)

Gilead joins Tik­Tok with on­col­o­gy aware­ness cam­paign fea­tur­ing di­verse group of can­cer ad­vo­cates

Gilead Sciences is taking over the opening page on TikTok for the next two weeks. A Gilead-sponsored video, featuring cancer advocates talking about equity and other issues, will show up as the landing page, called the “For You” page, for millions of TikTok watchers.

The cancer awareness campaign will begin on Monday and run for two weeks, a Gilead spokesperson told Endpoints News. The TikTok ad debut is timed around the ASCO medical conference, but the work is aimed more broadly at healthcare professionals, as well as people touched by cancer and people interested in advancing Black and general health equity.

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Stephen MacMillan, Hologic CEO (Photo by Riccardo Savi/Getty Images for Concordia Summit)

Il­lu­mi­na names Ho­log­ic CEO as new board mem­ber and chair

Illumina’s board appointed two new members, including Hologic CEO Stephen MacMillan as the non-executive chair, a move that followed a proxy fight that saw shareholders oust the company’s board chair.

The DNA sequencing company also appointed Scott Ullem, the CFO of Edwards Lifesciences, to the board, according to a company statement.

Illumina’s plans to add two new board members came as Carl Icahn waged a board proxy campaign culminating with shareholders electing his candidate, Andrew Teno, over board chair John Thompson. Illumina CEO Francis deSouza survived a threat to his board seat by securing more than twice the shareholder votes than his challenger. Another Illumina candidate, Robert Epstein, was also elected and remained on the board.

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Eu­ro­pean Par­lia­ment calls mem­ber states to ac­tion on an­timi­cro­bial re­sis­tance

Members of the European Parliament have called on EU countries to develop national action plans against antimicrobial resistance (AMR), calling it a top-three priority health threat.

Parliament on Thursday announced recommendations for the fight against AMR, including national action plans that must be updated at least every two years, an EU-level database tracking AMR and antimicrobial use and increased partnership between the pharma industry, patient groups and academia.

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Grail’s blood test charts path for di­ag­nos­ing pa­tients sus­pect­ed of hav­ing can­cer in large study: #AS­CO23

Grail’s vision is simple but bold. The blood testing company has long held that people are often diagnosed with cancer too late. If seemingly healthy people were screened for early signs of the disease before symptoms appear, they may be able to get more effective treatments that nip cancer in the bud.

That premise is the basis of Grail’s commercial blood test, Galleri, which searches for the genetic fingerprints of cancer in the blood. The test, launched in 2021, reaped $55 million in sales last year, but now the company is setting its sights on a new market: patients suspected of having cancer due to symptoms such as abdominal pain, rectal bleeding or unexplained weight loss. Rather than administering expensive scans or conducting invasive biopsies right away, Grail hopes doctors will consider a simple blood test.

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NICE rec­om­mends Bris­tol My­er­s' heart drug Camzyos in UK

Bristol Myers Squibb’s heart drug Camzyos has been recommended by the National Institute for Health and Care Excellence as the medication inches closer to approval in the UK and Europe.

In final draft guidance released Friday, NICE recommended mavacamten (branded as Camzyos) as an add-on to standard care for symptomatic obstructive hypertrophic cardiomyopathy.

Obstructive HCM is a heart condition that occurs when part of the muscular wall in the heart becomes thicker, which can then reduce blood supply to the rest of the body.

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