Therapeutic Goods Administration

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Group.png Therapeutic Goods Administration  
(Regulatory agencyWebsiteRdf-entity.pngRdf-icon.png
Therapeutic Goods Administration logo.png
Formation1989
HeadquartersACT, Australia
InterestsAHPRA
The medicine regulatory agency most captured by Big Pharma in the world.

The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government.[1] As part of the Department of Health, the TGA regulates the quality, supply and advertising of medicines, pathology devices, medical devices, blood products and most other therapeutics. Any items that claim to have a therapeutic effect, are involved in the administration of medication, or are otherwise covered by the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990, or a ministerial order, must be approved by the TGA and registered in the Australian Register of Therapeutic Goods.[2]

Regulatory capture

A 2022 study by Maryanne Demasi published in the British Medical Journal[3] investigated the connection between Big Pharma and drug regulators. It found that:


Of the six regulators, Australia had the highest proportion of budget from industry fees (96%) and in 2020-2021 approved more than nine of every 10 drug company applications. Australia’s Therapeutic Goods Administration (TGA) firmly denies that its almost exclusive reliance on pharmaceutical industry funding is a conflict of interest (COI). In response to a query, the agency said, “All fees and charges are prescribed in our legislation. To provide transparency, the TGA fees and charges are published on the TGA website.”

In Australia, the membership of the TGA’s Advisory Committee on Vaccines is published on the agency’s website. The forms for recording past and current financial and non-financial interests are not, however, made public. Freedom of Information (FOI) Act request for their financial disclosures in August 2020 had names and details of the disclosures redacted.[4]

Sociologist Donald Light of Rowan University in New Jersey, US, who has spent decades studying drug regulation, says, “Like the FDA, the TGA was founded to be an independent institute. However, being largely funded by fees from the companies whose products it is charged to evaluate is a fundamental conflict of interest and a prime example of institutional corruption.”



References