From FDA to MHRA: are drug regulators for hire?
Key Excerpts from Article on Website of The BMJ (Formerly British Medical Journal)
Posted: July 24th, 2022
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.” 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 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. 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. 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. 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.
Note: For more on this massive legal corruption, see this article. For more along these lines, see concise summaries of deeply revealing news articles on corruption in government and in Big Pharma from reliable major media sources.