President Donald Trump and FDA Commissioner Stephen Hahn (AP Images)

FDA is­sues fi­nal rule al­low­ing im­por­ta­tion of drugs from Cana­da — but al­so keeps the pow­er to re­voke it

Just over a month away from the pres­i­den­tial elec­tion, the FDA has is­sued a fi­nal reg­u­la­tion ful­fill­ing Pres­i­dent Trump’s promise to let states im­port cer­tain pre­scrip­tion drugs from Cana­da.

On Thurs­day, Trump told a crowd in North Car­oli­na that the new rule goes in­to ef­fect “to­day.” But the pub­lished reg­u­la­tion states that it won’t take ef­fect for 60 days. And even then, it could be a while be­fore cheap­er drugs make it across the bor­der.

Ac­cord­ing to the rule, states, ter­ri­to­ries, tribes, phar­ma­cists and whole­salers would need to set up new pro­grams and ap­ply to im­port the drugs, which would have to meet sev­er­al spec­i­fi­ca­tions. The prod­ucts would need to be re­la­beled and test­ed for “au­then­tic­i­ty and degra­da­tion,” ac­cord­ing to the FDA. And the pro­grams must demon­strate “sig­nif­i­cant cost re­duc­tions” to the con­sumer.

“If you put Cana­di­an drugs on a dogsled and point­ed it in the di­rec­tion of Flori­da, the dogs would ar­rive long be­fore any drugs through this reg­u­la­to­ry pro­pos­al,” for­mer HHS of­fi­cial Chris Meekins told the Wash­ing­ton Post back in De­cem­ber.

Trump signed an ex­ec­u­tive or­der in Ju­ly di­rect­ing the FDA to com­plete the “rule­mak­ing process” to al­low the im­por­ta­tion of Cana­di­an pre­scrip­tion drugs. Un­der a law es­tab­lished in 2003, such im­por­ta­tion is on­ly al­lowed if cer­ti­fied by the HHS sec­re­tary. Alex Azar has be­come the first sec­re­tary to for­mal­ly do so.

Drugs that have been ap­proved by Cana­da’s Health Prod­ucts and Food Branch and meet the con­di­tions of an FDA-is­sued NDA or AN­DA will be el­i­gi­ble. In a press brief­ing on Fri­day, HHS chief of staff Bri­an Har­ri­son said that safe­ty has been “at the fore­front of our ef­forts.”

“We’ve cre­at­ed smart safe op­por­tu­ni­ties for Amer­i­cans to se­cure low­er cost of drugs through im­por­ta­tion as no pres­i­dent has ever done be­fore,” Har­ri­son said in the brief­ing.

But oth­ers are skep­ti­cal that the reg­u­la­tion will be ef­fec­tive in low­er­ing drug costs. In a New Eng­land Jour­nal of Med­i­cine Per­spec­tive piece pub­lished in May, Wash­ing­ton Uni­ver­si­ty as­so­ciate law pro­fes­sor Rachel Sachs and Uni­ver­si­ty of Michi­gan law pro­fes­sor Nicholas Bagley sug­gest­ed the Trump ad­min­is­tra­tion could be do­ing more to make drugs af­ford­able.

“Far from a bold ini­tia­tive to help peo­ple af­ford their pre­scrip­tion drugs, the pro­pos­al seems de­signed to al­low the Trump ad­min­is­tra­tion to claim that it is tak­ing ac­tion, even as it op­pos­es con­gres­sion­al leg­is­la­tion that would sharply curb some drug prices,” the piece states.

Bagley and Sachs al­so point­ed out that the ini­tial pro­pos­al lacked guid­ance on how states can prove the im­port­ed drugs will re­duce costs. Cana­di­an reg­u­la­tors could change their rules to dis­cour­age ex­por­ta­tion, or sav­ings could ben­e­fit the whole­salers or the health care providers pre­scrib­ing the drugs, rather than pa­tients, they said. “Im­por­ta­tion might still save mon­ey, at least for some drugs, but a raw com­par­i­son of prices in the Unit­ed States and Cana­da pro­vides very thin sup­port for that con­clu­sion.”

Alexan­der Gaffney of Politi­co’s Agen­cy­IQ not­ed that the fi­nal­ized reg­u­la­tion in­cludes lan­guage which could al­low the FDA to re­voke im­por­ta­tion pro­grams.

“This will be a game-chang­er for Amer­i­can se­niors,” Trump tout­ed Thurs­day in a speech pre­sent­ing his Amer­i­ca First health­care plan. “And by al­low­ing you to do this through Cana­da, we’re do­ing it very, very quick­ly. So it goes very fast.”

The pres­i­dent al­so promised $200 pre­scrip­tion drug coupons to Medicare ben­e­fi­cia­ries, which he said will come from $6.6 bil­lion in sav­ings that do not cur­rent­ly ex­ist — or from phar­ma’s cof­fers.

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.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; 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.

The slate of products we’re offering here at Endpoints is continuing to grow, and it’s not just limited to editorial. If you haven’t, do visit your reader profile to see if there are any other weekly newsletters you’re interested in — as each comes with its own exclusive content. And don’t miss the publisher’s note from Arsalan Arif on Endpoints Studio, our latest avenue for advertising on Endpoints.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Janet Woodcock (AP Images)

Janet Wood­cock plots her fu­ture at FDA, with se­nior ad­vi­sor role to fall back on if Califf wins con­fir­ma­tion

Acting FDA commissioner Janet Woodcock has been the face of just about every drug approval decision at the agency since the turn of the century. Since the pandemic began, she’s moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed, leading the drive for work on Covid-targeted mAbs and antivirals.

Looking forward — and pending a quick Senate confirmation to cement Rob Califf’s return to the top of FDA early next year — Woodcock’s role at the agency will again be in flux.

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Richard Pazdur (via AACR)

Ac­cel­er­at­ed ap­proval re­forms need mean­ing­ful con­fir­ma­to­ry tri­al im­prove­ments, pro­fes­sors write in Sci­ence

Outside of Covid-19, 2021 has been the year of the accelerated approval.

Beginning last spring, FDA openly challenged six “dangling” accelerated approvals (hadn’t confirmed their clinical benefit yet), three of which were later pulled by the companies.

Then in June, FDA pulled out the accelerated approval pathway, seemingly out of nowhere, to sign off on Biogen’s controversial Alzheimer’s drug Aduhelm. It hadn’t even been mentioned at the drug’s adcomm.

Common performs onstage, December 2020 (Getty Images)

Com­mon, Jamie Foxx among celebs stand­ing up for clin­i­cal tri­als in star-stud­ded can­cer group's pan­dem­ic push

Healthcare screenings and clinical trial enrollment were battered by the pandemic. But the well-known celebrity-backed Stand Up To Cancer non-profit, along with pharma and advocacy partners, has been working to reverse that and make up lost ground, by stepping up awareness campaigns.

Twelve campaigns launched in 2020 and another five in 2021 amplify the need for cancer screening and care, especially for underserved communities. While pharma companies have long been donors to the cancer research group, Covid brought new support — and increased awareness efforts.

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News.