When is a drug re­al­ly a de­vice? Court knocks down FDA ap­peal in try­ing to sort that grey area

It’s al­ways a sur­prise when a court has to step in to tell the FDA that it erred in per­form­ing one of its main du­ties: clas­si­fy­ing whether a med­ical prod­uct is drug or a de­vice.

But that’s what the US Court of Ap­peals for the Dis­trict of Co­lum­bia did on Fri­day, mak­ing clear to the world’s top drug reg­u­la­tor that Genus Med­ical Tech­nolo­gies’ con­trast agent bar­i­um sul­fate (al­so known as Vanil­la SilQ) should not be con­sid­ered a drug, as the FDA had said, but a med­ical de­vice.

The case is a tricky one, as the ap­peals court even ac­knowl­edges in a foot­note, “We note that it is not im­me­di­ate­ly ob­vi­ous to us how a con­trast agent sat­is­fies” one of the FDA’s med­ical de­vice de­f­i­n­i­tion’s re­quire­ments. But the court knocked down the no­tion that if, as FDA claims, a med­ical prod­uct sat­is­fies the statu­to­ry de­f­i­n­i­tions of both a “drug” and a “de­vice,” the FDA has broad dis­cre­tion to reg­u­late the prod­uct un­der ei­ther cat­e­go­ry.

The ques­tion­able prod­uct in this case is bar­i­um sul­fate, which works by coat­ing an in­di­vid­ual’s esoph­a­gus, stom­ach, or in­testines so that physi­cians can more clear­ly see ar­eas on a CT scan or X-ray ex­am. Genus took the ar­gu­ment that bar­i­um sul­fate can’t be a drug be­cause its “pri­ma­ry in­tend­ed pur­pos­es” are not “through chem­i­cal ac­tion with­in or on the body,” where­as the FDA said the prod­ucts should be clas­si­fied as drugs “be­cause they are ar­ti­cles in­tend­ed for use in the di­ag­no­sis of dis­ease.”

FDA’s Of­fice of Com­bi­na­tion Prod­ucts, which is of­fi­cial­ly re­spon­si­ble for pro­vid­ing a for­mal, bind­ing de­ter­mi­na­tion on a prod­uct’s clas­si­fi­ca­tion, said Vanil­la SilQ prod­ucts ap­peared to meet both the de­f­i­n­i­tions for a de­vice and a drug, al­though the agency said it want­ed to uni­form­ly reg­u­late all con­trast agents as drugs.

That ini­tial de­ci­sion would’ve proved cost­ly for Genus as it’s con­sid­er­ably more ex­pen­sive to mar­ket a drug than a de­vice. The com­pa­ny told the court that seek­ing de­vice clear­ance for Vanil­la SilQ would cost about $60,000, where­as if it were a drug, Genus said it would cost more than $500,000 to ob­tain pre-mar­ket ap­proval, in ad­di­tion to a re­cur­ring, an­nu­al cost of more than $186,000 to keep mar­ket­ing the prod­ucts.

Genus then sued FDA in dis­trict court in 2019, and lat­er that year, the court ruled in fa­vor of Genus, con­clud­ing that the plain lan­guage of the Food, Drug, and Cos­met­ic Act “un­am­bigu­ous­ly re­quires that ‘a prod­uct that meets the de­vice de­f­i­n­i­tion must be reg­u­lat­ed as such.’”

The court hear­ing FDA’s ap­peal this year, mean­while, points to the agency’s guid­ance from 2017 not­ing that prod­ucts that may not ex­act­ly be in­stru­ments or ap­pa­ra­tus­es still may be clas­si­fied as de­vices. For in­stance, “gels or pow­ders put on the skin” come with­in the in­stru­ment clause when used “as a bar­ri­er,” gas­es can sat­is­fy the clause when “used as space fillers,” and some liq­uids qual­i­fy as de­vices when “used to clean ei­ther sur­gi­cal in­stru­ments or con­tact lens­es,” the court not­ed.

In sid­ing with Genus, the ap­peals court al­so said the agency didn’t go far enough in ex­plain­ing its de­ci­sion. “The FDA is not en­tire­ly wrong that the drug and de­vice de­f­i­n­i­tions over­lap — they do, in part. But it fell short in nei­ther ac­knowl­edg­ing the de­tailed in­stru­ment clause nor pro­vid­ing a law­ful and nonar­bi­trary ex­pla­na­tion of whether and how reg­u­lat­ing Vanil­la SilQ as a drug ac­cords with both that clause and the mode-of-ac­tion ex­clu­sions in the de­vice de­f­i­n­i­tion.”

At­tor­neys at Hy­man, Phelps & Mc­Na­ma­ra, which rep­re­sent­ed Genus, said the de­ci­sion has “wide-rang­ing im­pli­ca­tions for FDA’s as­ser­tion of dis­cre­tion in clas­si­fy­ing and reg­u­lat­ing med­ical prod­ucts. The Court de­ci­sion lim­it­ing FDA’s dis­cre­tion pro­vides reg­u­la­to­ry cer­tain­ty for de­vice man­u­fac­tur­ers, as the claimed dis­cre­tion, if rec­og­nized by the Court, would have meant that any med­ical de­vice po­ten­tial­ly could be clas­si­fied and reg­u­lat­ed as a drug.”

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

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Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

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SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

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How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

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Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

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Re­gen­eron's Evkeeza shows promise in curb­ing high triglyc­erides, but will ge­net­ic dis­par­i­ties lim­it use?

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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