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.”

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

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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.