Are drug regulators for hire?

From FDA to MHRA: are drug regulators for hire?

Proportion of budget derived from Industry

European Medicines Agency, 89% (2022)

Therapeutic Goods Administration, 96%

US Food and Drug Administration, 56% (Total budget $6,100,000,000)

Medicines and Healthcare Products Regulatory Agency, 86%

Japan, PDMA 85%

Health Canada, 50.5% (Total budget C$2,700,000,000)

Australia TGA and Canada HC

Conflicts of interests NOT available as public information

Covid-19 vaccine committee members who declared a financial CoI

UK, HMRA, 32%

Australia, TGA, 50%

Japan, PMDA, 75%

Regulators do NOT routinely receive patient level datasets

Australia, TGA

Europe, EMA

UK, MHRA

Canada, HC

Proportion of decisions to recommend new medicines v did not approve

Australia, TGA, 94%

Europe, EMA, 88%

UK, MHRA, 98.5%

US, FDA, 69%

Canada, HC, 83%

The revolving door

FDA, nine out of 10 of its past commissioners, 2006 to 2019 went on to secure roles linked with pharmaceutical companies

1992, US Congress

Passed the Prescription Drug User Fee Act (PDUFA)

Allowing industry to pay “user fees” directly to FDA

2005 UK, House of Commons’ health committee

Evaluated the influence of the drug industry on health policy,

including the Medicines and Healthcare Products Regulatory Agency (MHRA).

The committee was concerned

Industry funding could cause MHRA, 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.”

BMJ investigation (2022)

We found that industry money permeates the globe’s leading regulators,

raising questions about their independence

Industry money saturates the globe’s leading regulators.

The BMJ found that the majority of regulators’ budget

—particularly the portion focused on drugs—

is derived from industry fees

A string of drug and device scandals

Opioids, Alzheimer’s drugs, influenza antivirals, pelvic mesh, joint prostheses, breast and contraceptive implants, cardiac stents, pacemakers.

Sociologist Donald Light, Rowan University, New Jersey

“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.”

It is no longer possible for doctors and patients to receive unbiased, rigorous evaluations from drug regulators.

“Countries have independent safety boards for airlines and their passengers. Why not for drugs and patients too?”

FDA

“It’s the opposite of having a trustworthy organisation independently and rigorously assessing medicines.

They’re not rigorous, they’re not independent, they are selective, and they withhold data.

Doctors and patients must appreciate how deeply and extensively drug regulators can’t be trusted so long as they are captured by industry funding.”

External advisers

Advisory panels intended to provide regulators with independent expert advice

BMJ investigation

Several expert advisers for covid-19 vaccine advisory committees in the UK and US had financial ties with vaccine manufacturers

Revisiting financial conflicts of interest in FDA advisory committees

Large study, FDA advisory committee members over 15 years,

those with financial interests solely in the sponsoring firm were more likely to vote in favour of the sponsor’s product.

TGA (FoI in BMJ)

Conducted its covid-19 vaccine assessments based on “the information provided by the vaccine’s sponsor.”

TGA said it had not seen the source (individual participant level datasets) data from the covid-19 vaccine trials.