Follow the money. Drug regulators for hire?
It was just last month that we reported on the phenomenon of the science following the money, pointing especially to drug regulators like the Food and Drug Administration receiving a large proportion of their funding from the companies they regulate, like COVID-19 manufacturer Pfizer (and we also noted the close relationship these pharmaceutical companies have with the media and governments, via ownership and donations).
Now there is a new article in the respected medical journal, The BMJ, shedding new light on the topic. Highlights include:
- “Over the past decades, regulatory agencies have seen large proportions of their budgets funded by the industry they are sworn to regulate.”
- “In 1992, the US Congress passed the Prescription Drug User Fee Act (PDUFA), allowing industry to fund the US Food and Drug Administration (FDA) directly through “user fees” intended to support the cost of swiftly reviewing drug applications. With the act, the FDA moved from a fully taxpayer funded entity to one supplemented by industry money. Net PDUFA fees collected have increased 30 fold—from around $29m in 1993 to $884m in 2016.”
- “In Europe, industry fees funded 20% of the new EU-wide regulator, the European Medicines Agency (EMA), in 1995. By 2010 that had risen to 75%; today it is 89%.”
“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).”
- “We found that industry money permeates the globe’s leading regulators, raising questions about their independence, especially in the wake of a string of drug and device scandals.”
- “An 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.”
- “A BMJ investigation last year found several expert advisers for covid-19 vaccine advisory committees in the UK and US had financial ties with vaccine manufacturers—ties the regulators judged as acceptable.”
- “Recently, a group of more than 80 professors and researchers called the Public Health and Medical Professionals for Transparency sued the FDA for access to all the data which the agency used to grant licensure for Pfizer’s covid-19 vaccine.19 The FDA argued that the burden on the agency was too great and requested that it be allowed to release appropriately redacted documents at the rate of 500 pages a month, a speed that would take approximately 75 years to complete.”
- “Critics argue that regulatory capture is not only being baked in by the way in which agencies are funded, but also staffed. A “revolving door” has seen many agency officials end up working or consulting for the same companies they regulated.” Source.
Okay then.