Are drug regulators sufficiently independent from the companies they are meant to regulate?
Patients and doctors expect drug regulators to provide an unbiased, rigorous assessment of new medicines before they hit the market. But an investigation published by The BMJ today finds 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.
Over the past decades, regulatory agencies have seen large proportions of their budgets funded by the industry they are sworn to regulate, explains investigative journalist Maryanne Demasi.
Industry fees to the US Food and Drug Administration (FDA) have increased 30 fold—from around $29m in 1993 to $884m in 2016, while in Europe, industry fees now fund 89% of the European Medicines Agency (EMA), up from 20% in 1995.
In 2005, the UK House of Commons' health committee evaluated the influence of the drug industry on health policy. 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.
Of these, 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). But 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 W 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."
Concern over COIs is not just directed at those who work for the regulators but extends to the advisory panels intended to provide regulators with independent expert advice, notes Demasi.
Of the regulators approached by The BMJ, only Canada's did not routinely seek advice from an independent committee and its evaluation team was the only one completely free of financial COIs.
European, Japanese, and UK regulators publish a list of members with their full declarations online for public access, while the FDA judges COIs on a meeting-by-meeting basis and can grant waivers allowing participation of members.
Joel Lexchin, a drug policy researcher at York University in Toronto, says, "People should know about any financial COIs that those giving advice have so that they can evaluate whether those COIs have influenced the advice they are hearing. People need to be able to trust what they hear from public health officials and a lack of transparency erodes trust."
Demasi acknowledges that there have been improvements in the transparency and accessibility of trial data, but points out that most regulatory agencies do not undertake their own assessment of individual patient data, but rather rely on summaries prepared by the drug sponsor.
Industry fees are also used to help speed up approval of new treatments, she adds.
Today, all major regulators offer "expedited pathways" but there is concern that quicker approval decisions have resulted in new drugs that were more likely to be withdrawn for safety reasons, more likely to carry a subsequent black box warning, and more likely to have one or more dosage forms voluntarily discontinued by the manufacturer.
Critics also point to a regulator-industry "revolving door" that has seen many agency officials end up working or consulting for the same companies they regulated.
Experts say that both small and large structural changes are necessary to help restore regulators' ability to carry out independent decision making, free of industry influence.
Donald Light argues that regulators now need their own watchdog and is calling for a drug and vaccine safety board, independent of the drug regulator, with the authority, staffing, and funds to investigate incidents of patient harm. "Countries have independent safety boards for airlines and their passengers. Why not for drugs and patients too?" he says.
More information: From FDA to MHRA: are drug regulators for hire?, The BMJ (2022). DOI: 10.1136/bmj.o1538