Therapeutic Goods Administration

Therapeutic Goods Administration   (Regulatory agency)
Formation	1989
Headquarters	ACT, Australia
Interests	AHPRA
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. 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.

Regulatory capture

A 2022 study by Maryanne Demasi published in the British Medical Journal 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.

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.”

Revolving door

Antother revolving door is Mark McDonald, who worked for the TGA for 21 years in the Prescription Medicines Authorisation Branch, writing about the fast-track pathways to drug approvals He then went on to Big Pharma GSK, which is very much for fast-tracked drug approval.

In December 2023, Professor John Skerritt, head of the Therapeutic Goods Administration, was appointed to the Medicines Australia Board as an Independent Selected Director, with an undisclosed remuneration amount. Medicines Australia is the lobby for the pharmaceutical industry in Australia. Skerritt said he is looking forward to "working closely with the industry at this transformational time."

"I am delighted to announce Professor John Skerritt will be joining the Medicines Australia Board to provide strategic leadership, informed by decades of government experience, at a pivotal time for the pharmaceutical industry," Medicines Australia Board Chair Anna Lavelle, said. "As a former Deputy Secretary of the Australian Department of Health and Aged Care and former head of the Therapeutic Goods Administration, John’s knowledge of the Australian therapeutics regulatory environment is unmatched...This expertise is critical as Australia seeks to harness the step change in technology and ensure that Australian patients have access to new innovative therapies as they become available...John’s deep understanding of government, and policy development and implementation, will be invaluable as Medicines Australia builds on the work undertaken to date with the Government on the reforms needed to speed up patient access to new medicines."

After he left TGA in April 2023, he "ended up on about 10 different advisory committees to government and universities"..."I’m doing an awful lot of stuff on building the messenger RNA framework in Australia, both therapeutics and vaccines," he said.

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