FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is of­fer­ing more of an ex­pla­na­tion of the guardrails around its pro­gram that may soon al­low states to im­port pre­scrip­tion drugs in some se­lect cir­cum­stances from Cana­da, but on­ly if such im­ports will re­sult in sig­nif­i­cant cost re­duc­tions for con­sumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule al­low­ing such im­ports is stalled, the new Q&A guid­ance spells out the var­i­ous re­stric­tions that states will have to abide by, po­ten­tial­ly sig­nal­ing that a state ap­proval is com­ing.

For in­stance, there’s a long list of drugs that will be ex­clud­ed from all state im­por­ta­tion plans, in­clud­ing all bi­o­log­ics, which are gen­er­al­ly some of the most ex­pen­sive drugs, as well as con­trolled sub­stances, in­fused drugs, and drugs that are in­ject­ed in­tra­venous­ly (in­to a vein), in­trathe­cal­ly (in­to the spinal flu­id), or in­traoc­u­lar­ly (in­to the eye), and drugs that are sub­ject to a risk eval­u­a­tion and mit­i­ga­tion strat­e­gy, among oth­ers.

An FDA spokesper­son con­firmed to End­points News last month that a meet­ing on March 31 was the first op­por­tu­ni­ty for FDA and HHS to dis­cuss im­port plans with states that have tak­en sig­nif­i­cant ac­tion to­ward de­vel­op­ing their pro­pos­als, which cur­rent­ly in­clude Flori­da, Col­orado, Maine, New Mex­i­co and Ver­mont.

Flori­da Gov. Ron De­San­tis has been at the fore­front of this push as he’s spent months lament­ing the FDA’s slow­ness in re­spond­ing to state plans and he pre­vi­ous­ly signed a bill in 2019 cre­at­ing the frame­work to be­gin im­port­ing. He has since promised that Flori­da could po­ten­tial­ly save be­tween $80 mil­lion and $150 mil­lion from the im­ports in the first year alone.

But the dev­il will be in the de­tails of how states can show the math on these steep cost re­duc­tions, par­tic­u­lar­ly as Cana­di­an health of­fi­cials have made clear their op­po­si­tion to these im­ports in re­cent years, and as there may be fur­ther ex­port re­stric­tions.

Cana­da’s for­mer act­ing am­bas­sador told Trump of­fi­cials back in 2019 that “it is im­por­tant to rec­og­nize that Cana­da’s mar­ket for phar­ma­ceu­ti­cals is too small to have any re­al im­pact on US drug prices.”

Mean­while, Cana­da al­so es­tab­lished a sys­tem where cer­tain drugs in­tend­ed for the Cana­di­an mar­ket are banned from dis­tri­b­u­tion out­side the coun­try if the sale “would cause or wors­en a drug short­age.”

And the FDA has made clear in a slide deck on such state pro­pos­als, that the is­sue of cost re­duc­tions will be a fac­tor as states will have to show how their pro­pos­als “will re­sult in a sig­nif­i­cant re­duc­tion in the cost to the Amer­i­can con­sumer.”

An HHS se­nior econ­o­mist Aaron Kears­ley al­so pre­vi­ous­ly pre­sent­ed slides to states, em­pha­siz­ing that state pro­pos­als should in­clude all costs as­so­ci­at­ed with im­ple­ment­ing the plans, in­clud­ing “im­porter price markups – Oth­er trans­porta­tion and lo­gis­ti­cal costs not cap­tured by the im­porter price markup – Costs as­so­ci­at­ed with drug sam­ples, test­ing, and oth­er re­quire­ments un­der Sec­tion 804 and the Im­por­ta­tion of Pre­scrip­tion Drugs Fi­nal Rule.”

Fur­ther­more, im­por­ta­tion plans must in­clude re­la­bel­ing plans as the Cana­di­an drugs have to be con­vert­ed to US la­bels, and the FDA is re­quest­ing side-by-side com­par­isons of the FDA-ap­proved la­bel­ing and the pro­posed la­bel­ing with all dif­fer­ences an­no­tat­ed and ex­plained.

Mean­while, fur­ther re­stric­tions may again cur­tail what drugs are in­clud­ed in such pro­pos­als as the fi­nal rule re­quires man­u­fac­tur­ers or im­porters to test the in­com­ing drugs for au­then­tic­i­ty, degra­da­tion, and to en­sure that the el­i­gi­ble pre­scrip­tion drugs are in com­pli­ance with es­tab­lished spec­i­fi­ca­tions and stan­dards.

“The re­sults of this test­ing will be sub­ject to re­view and ac­cep­tance by FDA,” the Q&A guid­ance says.

The fi­nal rule al­so re­quires that the for­eign sell­er be li­censed to whole­sale drugs by Health Cana­da and reg­is­tered with FDA as a for­eign sell­er, but it “can­not have an in­ter­na­tion­al phar­ma­cy li­cense that al­lows it to dis­trib­ute drugs that are ap­proved by coun­tries oth­er than Cana­da and that are not HPFB-ap­proved for dis­tri­b­u­tion in Cana­da.”

FDA fur­ther ex­plained that while it may use a phased re­view process for eval­u­at­ing state im­port pro­pos­als that do not iden­ti­fy a for­eign sell­er ini­tial­ly, state plans can­not be au­tho­rized by FDA with­out a for­eign sell­er.

The Biden ad­min­is­tra­tion pre­vi­ous­ly sought to dis­miss a PhRMA law­suit last sum­mer seek­ing to stop the im­ports, al­though the re­sult of that suit re­mains un­known.

The FDA al­so made clear that while the fi­nal rule gov­ern­ing these im­port pro­grams does not pro­vide a time­frame for re­view­ing a state’s pro­pos­al, the time­frame for re­view “is de­pen­dent up­on the in­clu­sion of all re­quire­ments of the rule” and the FDA ex­pects to pro­vide feed­back on a pro­pos­al’s ad­her­ence to the re­quire­ments with­in six months from sub­mis­sion.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

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Phar­ma re­acts to post-Roe; Drug­mak­ers beef up cy­ber de­fense; Boehringer, Roche qui­et­ly axe drugs; 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 a reminder, we are off on Monday for the Fourth of July. I hope this recap will kick off your (long) weekend well and that the rest of it will be just what you need. See you next week for a shortened edition!

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Eric Hughes, incoming Teva EVP of global R&D and CMO

Te­va chief raids Ver­tex for his new glob­al head of re­search and de­vel­op­ment

Teva CEO Kåre Schultz has found his new R&D chief and CMO in Vertex’s ranks.

The global generics giant, which has some 3,500 staffers in the R&D group, has named Eric Hughes to the top research spot in the company. He’ll be replacing Hafrun Fridriksdottir, who held the role for close to five years, on Aug. 1.

Hughes hasn’t been at Vertex for long, though. He jumped from Novartis less than a year ago, after heading the immunology, hepatology & dermatology global development unit. Before that, he completed a five-year stint as head of early clinical research for the specialty discovery medicine department in the exploratory clinical & translational research group at Bristol Myers Squibb, according to his LinkedIn profile.

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#BIO22: Man­ag­ing a biotech in tur­bu­lent times. 'There's a per­fect shit­show out there'

On Tuesday, June 14, Endpoints News EIC John Carroll sat down with a group of biotech execs to discuss the bear market for industry stocks and how they were dealing with it. Here’s the conversation, which has been lightly edited for brevity.

Martin Meeson, sponsor opening:

Thank you, John. Hello everyone. My name’s Martin Meeson, I’m the CEO of Fujifilm Diosynth. For those of you who don’t know Fujifilm Diosynth, we operate in the development of clinical and commercial product scale up, we have facilities in Europe and the US, and around about 4,000 employees. We run on average about 150 programs, so when it comes to managing in turbulent times over the last two years, we’ve had quite a lot of experience of that. Not just keeping the clinical pipelines and the commercial pipelines open, but also our response to the pandemic and the molecules that we’ve had within there. One of the phrases that I coined probably about a year ago when we were talking at JP Morgan, was I talked about managing through turbulent times. Well, it’s become the fact that we are not managing and leading through these times, we are managing in them, which is why that’s really the purpose of and the topic that we’ve got today.

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Amgen's taking social media followers around the globe as it introduces the many different

From Tam­pa to Mu­nich, Am­gen’s ‘Places’ cam­paign in­tro­duces its lo­ca­tions around the world

Amgen is taking social media followers around the world with its latest corporate campaign. Called “Places of Amgen,” the twice monthly posts highlight the biopharma’s different offices and sites – and the people who work there.

Each post runs on LinkedIn, Facebook and Instagram with details about the work Amgen does in that location, when it was established, comments from people who work there and other interesting facts. The most recent one about Paris, France, for example, notes that Amgen France last year signed a French association charter committed to the inclusion of LBGT+ people in the workplace.

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Credit: Shutterstock

Bio­haven takes mi­graine cam­paign to pa­tients' Twit­ter feeds, months ahead of Pfiz­er takeover

Two weeks ago, Biohaven hit an all-time high in weekly Nurtec prescriptions. CEO Vlad Coric attributes at least some of that success to a new interactive Twitter campaign that encourages patients to free their feed of potential migraine triggers.

Earlier this month, Biohaven in partnership with Twitter launched the #RelieveYourFeed campaign that allows users to customize their app settings based on their migraine triggers.

Oncologists on Twitter are talking up ASCO studies, health equity and burnout, according to new deep dive research from Harris Poll (via Shutterstock)

What’s been on in­flu­en­tial on­col­o­gist­s' minds? Most­ly AS­CO, but al­so health eq­ui­ty, ac­cord­ing to new Har­ris Poll re­search

Over the past few months, oncologists have been talking a lot about the ASCO conference. Not surprising considering its import and the study data presented, but what may be less expected is the second most talked about topic of health equity.

That’s according to data from The Harris Poll and the new expert network the researcher is building out. While the company has been doing deep data dives into specific health issues or conditions for pharma clients, it’s now monitoring influencer networks of therapy area specialists to find out what experts are really thinking about.

Emer Cooke, ICRMA chair (AP Photo/Geert Vanden Wijngaert)

ICM­RA to launch sev­er­al reg­u­la­to­ry pi­lot pro­grams cen­tered around man­u­fac­tur­ing in­spec­tions

As regulatory agencies look to catch up on inspections amid the Covid-19 pandemic, ICMRA is unveiling several pilot programs to address industry applications and inspections.

ICMRA, which is made up of the world’s top drug regulators, is launching multiple pilot programs, including two regulatory pilots addressing facility inspections for chemistry and manufacturing controls (CMC) and post-approval change (PAC) submission assessments and related regulatory actions.

No­var­tis to re­sume the pro­duc­tion of two ra­di­oli­gand ther­a­pies af­ter re­solv­ing qual­i­ty is­sues

Earlier this year, Novartis touted its radioligand as a major piece to counter competition in the cancer space. However, the physical production of its products has had anything but a smooth ride.

In May, Novartis had to suspend production of Lutathera and Pluvicto, its two primary radiotherapies. According to the company, this was done out of an abundance of caution as a result of potential quality issues identified in its manufacturing. The production suspension impacts the commercial and clinical trial supply of the products.