Tag: user fees

They’re lying about Pfizer—The road to Aduhelm: What one ex-FDA adviser called ‘probably the worst drug approval decision in recent US history’ for an Alzheimer’s treatment

Ms. Cat

The road to Aduhelm: What one ex-FDA adviser called ‘probably the worst drug approval decision in recent US history’ for an Alzheimer’s treatment

Worse yet, according to the critics, the FDA gave Aduhelm accelerated approval in June, another possibility that had not been raised before the committee. (In notable contrast, the FDA did not act in an accelerated fashion when it finally approved the Pfizer/BionTech vaccine for Covid-19 in August.)**

…

Carome believes the shift at the FDA began in earnest in 1992, when the funding stream for the government agency changed. Under an act of Congress that year, the pharmaceutical industry paid “user fees” to support its regulators. The idea was that since the companies would benefit from the FDA’s decisions, they should cover the costs. User fees now pay for roughly 45% of the FDA’s budget.

“The politicians like user fees, because that means they don’t have to allocate taxpayer money,” Carome said, “but what this has done is encourage the agency to become a partner with industry. This has led to regulatory capture of the agency, which is now looking at best interests of the company rather than the best interests of public health.”

**They’re lying about this!? The FDA fast tracked Pfizer’s jab AND accelerated it’s review! The advisory committee didn’t even hold another meeting about the updated data from clinical trials! How is that not different?!

Pfizer, BioNTech’s coronavirus vaccine candidates get FDA’s ‘fast track’ status

FDA, under pressure, plans ‘sprint’ to accelerate review of Pfizer’s Covid-19 vaccine for full approval

FDA Reassigns Staff to Accelerate Full Approval for Pfizer’s COVID-19 Vaccine

Covid-19: FDA set to grant full approval to Pfizer vaccine without public discussion of data

Why Is the Gates Foundation Funding the UK’s Medicines Regulator?

Ms. Cat

Why Is the Gates Foundation Funding the UK’s Medicines Regulator?

“Safety in a world of user fees” is of paramount concern, concluded Lexchin. That was was back in 2017. Four years on, we are in the biggest health crisis of our lifetimes and the tasks performed by medicines regulators are more important than ever. New experimental vaccines and therapeutic treatments are rolling off the line in record time. But they’re also being authorised in record time — in some cases despite scant evidence of benefits (e.g., Remdesivir). And they’re earning record profits for their manufacturers. At the same time, promising repurposed off-patent medicines that do not offer lucrative financial returns are largely being ignored or are even being demonised by our medicines regulators.