Eli Lil­ly los­es case against Flori­da com­pound­ing phar­ma­cy

Eli Lil­ly suf­fered an­oth­er loss this week in its le­gal cam­paign against com­pound­ed ver­sions of its pop­u­lar di­a­betes and weight loss drug tirzepatide.

A Flori­da fed­er­al judge tossed Lil­ly’s law­suit against a Mi­a­mi com­pound­ing phar­ma­cy on Wednes­day, rul­ing that Lil­ly can’t “use state law as a back door to pri­vate­ly en­force” the Fed­er­al Food, Drug, and Cos­met­ic Act (FD­CA). The de­ci­sion comes just a cou­ple months af­ter an­oth­er Flori­da judge dis­missed a sep­a­rate case Lil­ly brought against a dif­fer­ent com­pound­ing phar­ma­cy.

Com­pound­ed drugs are med­i­cines that have been al­tered in some way to meet the spe­cial needs of a pa­tient. While they aren’t FDA-ap­proved, they are per­mit­ted in the US un­der cer­tain cir­cum­stances — for ex­am­ple, if a pa­tient can’t swal­low a tablet and needs a liq­uid for­mu­la­tion. But Lil­ly ar­gued in its re­cent law­suit that Rx­Com­pound­Store.com is not gen­uine­ly com­pound­ing ver­sions of its tirzepatide.

The phar­ma com­pa­ny ac­cused the phar­ma­cy of “sim­ply un­law­ful­ly man­u­fac­tur­ing pre­scrip­tion drugs with­out FDA ap­proval.”

Lil­ly and ri­val GLP-1 man­u­fac­tur­er No­vo Nordisk have brought a string of law­suits against well­ness cen­ters and com­pound­ing phar­ma­cies for what they be­lieve is im­prop­er mar­ket­ing of their di­a­betes and weight loss prod­ucts.

Judge Roy Alt­man wrote in a Wednes­day or­der that the fed­er­al gov­ern­ment has “‘near­ly ex­clu­sive’ au­thor­i­ty to en­force the FD­CA,” which was en­act­ed in 1938 and calls for the FDA to over­see and reg­u­late new drugs. The judge not­ed that “courts around the coun­try have gen­er­al­ly re­fused to en­croach on that au­thor­i­ty by ad­ju­di­cat­ing claims that a par­ty has (or has not) com­plied with the FD­CA.”

He cit­ed Lil­ly’s “near­ly iden­ti­cal” case against Wells Phar­ma­cy Net­work, which was shot down in a dif­fer­ent Flori­da fed­er­al court in Feb­ru­ary. Alt­man dis­missed the case with prej­u­dice, mean­ing Lil­ly can­not re­file in that court, adding that “any amend­ment would be fu­tile.”

Nei­ther Lil­ly nor Rx­Com­pound­Store.com re­spond­ed to re­quests for com­ment as of press time.