Re­searchers chal­lenge TGA

Pharmacy Daily - - News -

RE­SEARCHERS from Monash Univer­sity and Friends of Sci­ence in Medicine (FSM) have ar­gued that the Ther­a­peu­tic Goods Ad­min­is­tra­tion (TGA) “has failed, and will con­tinue to fail, in its duty to pro­tect Aus­tralians from in­ef­fec­tive health prod­ucts”.

The sci­en­tists and pub­lic health of­fi­cials con­tin­ued their anti-TGA rhetoric at the an­nual Aus­tralian Pub­lic Health Con­fer­ence held in Cairns this week.

Homeopa­thy asthma prod­ucts were cited as rem­edy ex­am­ples pro­moted with no warn­ing to con­sumers that in se­vere dis­ease their use could re­sult in death, said Pro­fes­sor Ken Har­vey.

“The TGA’s lat­est re­sponse to these con­cerns was to make no de­ci­sion,” Har­vey said de­scrib­ing this as “reg­u­la­tory paral­y­sis”.

Mal­colm Vick­ers, from Monash Univer­sity, ex­am­ined the way the TGA han­dled re­fer­rals from the in­de­pen­dent Com­plaints Res­o­lu­tion Panel (CRP) of un­ac­cept­able, often fraud­u­lent, ad­ver­tis­ing.

He claimed the TGA failed to deal with around 90% of 755 com­plaints re­ferred for reg­u­la­tory ac­tion.

FSM pres­i­dent Pro­fes­sor John Dwyer crit­i­cised the move in Jul this year to abol­ish the CRP, plac­ing the com­plaints man­age­ment process in the hands of the TGA.

Dwyer said ini­tial ex­pe­ri­ence with the TGA com­plaint sys­tem con­firmed his worst fears, cit­ing the lack of a search func­tion to as­sist in eval­u­a­tion of prod­ucts.

Con­fer­ence chair Har­vey added, “While this is con­ve­nient for in­dus­try and the TGA, it’s ap­palling con­sumer pro­tec­tion.

“Reg­u­la­tors are meant to keep every­one on a level play­ing field.

“With­out pub­li­cis­ing and en­forc­ing reg­u­la­tory breaches, the door is wide open for mis­lead­ing and de­cep­tive ad­ver­tis­ing and poor-qual­ity prod­ucts.

“We are now see­ing a pro­lif­er­a­tion of shonky prod­ucts and a race to the bot­tom by man­u­fac­tur­ers and ad­ver­tis­ers.”

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