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

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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.”

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