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.

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, 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.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

UP­DATE: Will Bio­gen ever pub­lish the tri­al re­sults for its new Alzheimer’s drug?

Usually when a new drug is approved by the FDA, physicians who might use that drug can turn to the medical literature for a deeper understanding of who exactly might benefit from it, what exactly occurred in the clinical trials (beyond the company’s press release), and why the agency signed off on it.

But in the case of Biogen’s new controversial Alzheimer’s drug Aduhelm (aducanumab), it’s unclear if the company will go the extra mile and try to publish the data, particularly as the only positive data was from a post-hoc analysis of one of the two trials that failed.

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Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.

FDA plans new stud­ies on ac­cel­er­at­ed ap­proval dis­clo­sures in bio­phar­ma ads

When people read biopharma companies’ websites about new drugs approved via the FDA’s accelerated pathway, like Biogen’s new Alzheimer’s drug, do they understand that these drugs may only be reasonably likely to predict clinical benefit and still require confirmatory studies?

That’s what the FDA’s Office of Prescription Drug Promotion wants to firm up as an agency analysis of direct-to-consumer websites for accelerated approval drugs previously found that only 21% of the disclosures used language directly from the label.

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FDA dips its toe in­to the world of pa­tient-re­port­ed out­comes for can­cer tri­als

While acknowledging the challenge of ensuring patient-reported outcome (PRO) data in cancer drug applications are consistent and of high quality, the FDA on Wednesday outlined its expectations for how this data on symptoms and functional impacts may aid the agency’s benefit/risk assessments.

Cancer drug trials typically employ standardized efficacy assessments of overall survival and tumor reduction measures, in addition to closely tracking any adverse events to evaluate a new drug’s safety and efficacy balance. But the FDA is also looking to better employ a core set of PROs to address disease symptoms, symptomatic adverse events, and physical function, all of which may be important contributors to a patient’s quality of life.

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