Are drug regulators for hire?

[wachumacallit]

BMJ study shows that Therapeutic Goods Administration (Australia, 2022) was 96% funded by pharmaceutical industry.

Edited February 14, 2025 by fyzygy

[Ishmael Fleishman]

...

Edited August 16, 2024 by Ishmael Fleishman

[wachumacallit]

It's appalling enough that drug manufacturers would submit not necessarily the safest, or most efficacious, but only the most lucrative products to the TGA for approval. It's doubly concerning that TGA operations are wholly contingent (i.e. financially dependent) on these (largely successful) industrial applications. It's triply concerning that this state of affairs (the full extent of the TGA's financial dependence) was disclosed only by means of a Freedom of Information request. 

 

This is industry self-regulation at its worst, with public health -- the ostensible goal of the TGA -- subservient to private economic interests. A sign of the times, to be sure. ARPANSA (self-regulatory lackey for the giant telecommunications sector) would be another case in point: a captive government agency masquerading as trustworthy guardian of public health and environmental safety. 

 

In an age of limitless profits, industrial self-regulation is a sick joke. But someone is laughing, all the way to the bank. 

 

[Ishmael Fleishman]

...

Edited August 16, 2024 by Ishmael Fleishman

[-RC-]

So to answer the OP's question, "Yes, absolutely!" 

Edited September 10, 2023 by -RC-

[wachumacallit]

Years later, realised I'd linked to the wrong YouTube video ... oops!

 

 

[wachumacallit]

And the paper he's referring to ... https://www.bmj.com/content/377/bmj.o1538

 

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.”

 

But for decades academics have raised questions about the influence funding has on regulatory decisions, especially in the wake of a string of drug and device scandals—including opioids, Alzheimer’s drugs, influenza antivirals, pelvic mesh, joint prostheses, breast and contraceptive implants, cardiac stents, and pacemakers.4567An analysis of three decades of PDUFA in the US has shown how a reliance on industry fees is contributing to a decline in evidentiary standards, ultimately harming patients.8 In Australia, experts have called for a complete overhaul of the TGA’s structure and function, arguing that the agency has become too close to industry.

 

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.”

Edited February 14, 2025 by fyzygy

[rottenjonny]

probably why they refuse to approve an otc CBD oil despite the scheduling allowing it. Meanwhile those on prescription need to pay over $150 a bottle.

[wachumacallit]

23 hours ago, rottenjonny said:

probably why they refuse to approve an otc CBD oil despite the scheduling allowing it

And let's not forget poor old kratom (still scheduled, alas). Better (for the economy) a synthetic opioid epidemic.