Aus­tralia fines Sack­ler-owned opi­oid maker

Antelope Valley Press - - Valley Life - By KRIS­TEN GELINEAU

SYD­NEY — Aus­tralia’s drug reg­u­la­tor has fined a phar­ma­ceu­ti­cal com­pany owned by the bil­lion­aire Sack­ler fam­ily over what it dubbed mis­lead­ing ad­ver­tis­ing for one of its opi­oid painkiller­s, as the coun­try grap­ples with surg­ing rates of opi­oid pre­scrip­tions and re­lated deaths.

Mundipharm­a Aus­tralia, the in­ter­na­tional af­fil­i­ate of OxyCon­tin maker Pur­due Pharma, was or­dered to pay penalties of 302,400 Aus­tralian dol­lars ($209,000) by the Ther­a­peu­tic Goods Ad­min­is­tra­tion over its pro­mo­tion of the opi­oid Tar­gin, the drug reg­u­la­tor said in a state­ment.

The fine against Mundipharm­a comes as Pur­due faces a bar­rage of law­suits in the United States ac­cus­ing it of de­cep­tive mar­ket­ing tac­tics that down­played the ad­dic­tive na­ture of its opi­oids.

In a story doc­u­ment­ing Aus­tralia’s bal­loon­ing opi­oid cri­sis ear­lier this year, The As­so­ci­ated Press re­ported that Mundipharm­a was fac­ing ac­cu­sa­tions from a lo­cal doc­tor and a doc­tors’ group that its Tar­gin ad­ver­tis­ing was mis­lead­ing. At the time, Aus­tralian Health Min­is­ter Greg Hunt told the AP he had asked the TGA to in­ves­ti­gate those claims.

In a state­ment last week, the TGA said it had is­sued 24 in­fringe­ment no­tices against Mundipharm­a af­ter de­ter­min­ing that its ad­ver­tis­ing of Tar­gin to health pro­fes­sion­als “was mis­lead­ing, im­bal­anced and oth­er­wise in­ac­cu­rate,” and thus breached the drug pro­mo­tion re­quire­ments set out in the code of con­duct by in­dus­try reg­u­la­tor Medicines Aus­tralia.

In Aus­tralia, drug com­pa­nies are banned from di­rectly ad­ver­tis­ing to con­sumers, though they are free to mar­ket their drugs to med­i­cal pro­fes­sion­als -- pro­vided they abide by the code of con­duct.

The TGA found fault with a sen­tence that ap­peared in the pro­mo­tional ma­te­ri­als that said: “Opi­oids should be used as part of mul­ti­modal pain man­age­ment plan and in an on­go­ing trial, as they are as­so­ci­ated with po­ten­tial harms, in­clud­ing un­sanc­tioned use, ad­dic­tion and over­dose.”

The TGA said the sen­tence “ap­peared to pos­i­tively en­cour­age the pre­scrip­tion of Tar­gin medicines for chronic non-can­cer pain.”

“The TGA con­sid­ers that opi­oids should not be rep­re­sented as a core com­po­nent of the multi-modal man­age­ment of chronic non-can­cer pain, and the de­ci­sion to pre­scribe opi­oids should be ap­proached with sig­nif­i­cant cau­tion,” the agency said.

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