Intended for healthcare professionals

Feature BMJ investigation

From FDA to MHRA: are drug regulators for hire?

BMJ 2022; 377 doi: https://doi.org/10.1136/bmj.o1538 (Published 29 June 2022) Cite this as: BMJ 2022;377:o1538
  1. Maryanne Demasi, investigative journalist
  1. Sydney, Australia
  1. maryannedemasi{at}hotmail.com

Patients and doctors expect drug regulators to provide an unbiased, rigorous assessment of investigational medicines before they hit the market. But do they have sufficient independence from the companies they are meant to regulate? Maryanne Demasi investigates

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 2016.1

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%.2

In 2005 in the UK, the House of Commons’ health committee evaluated the influence of the drug industry on health policy, including the Medicines and Healthcare Products Regulatory Agency (MHRA).3 The committee was concerned that industry funding could lead the agency to “lose sight of the need to protect and promote public health above all else as it seeks to win fee income from the companies.” But nearly two decades on, little has changed, and industry funding of drug regulators has become the international norm.

The BMJ asked six leading regulators, in Australia, Canada, Europe, Japan, the UK, and US, a series of questions about their funding, transparency in their decision making (and of data), and the rate at which new drugs are approved. We found that industry money permeates the globe’s leading regulators, raising questions about …

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