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From FDA to MHRA: are drug regulators for hire?

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 …

Australia , Canada , New-jersey , United-states , Japan , Germany , United-kingdom , London , City-of , Toronto , Ontario , Japanese

JoNova » "Big Pharma is the worlds biggest lobbying organisation" » Print

JoNova » "Big Pharma is the worlds biggest lobbying organisation" » Print
joannenova.com.au - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from joannenova.com.au Daily Mail and Mail on Sunday newspapers.

West-virginia , United-states , Vivek-ramaswamy , Shawn-ryan-shawnryan , Anthony-fauci , James-smith-stephen-hahn , Pfizer , Supreme-court , Twitter , Shawn-ryan , James-smith , Stephen-hahn

"Big Pharma is the worlds biggest lobbying organisation" « JoNova

"Big Pharma is the worlds biggest lobbying organisation" « JoNova
joannenova.com.au - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from joannenova.com.au Daily Mail and Mail on Sunday newspapers.

West-virginia , United-states , James-smith-stephen-hahn , Vivek-ramaswamy , Shawn-ryan-shawnryan , Anthony-fauci , Supreme-court , Pfizer , Twitter , Shawn-ryan , James-smith , Stephen-hahn

Walgreens Can Begin Covid Vaccinations In Nursing Houses Earlier Than Christmas • MV TELEGRAPH

A pharmacist helps a customer at a Walgreens pharmacy in Wheeling, Illinois.

United-states , Illinois , Iowa , America , Americans , Moncef-slaoui , Stephen-hahn , Walgreens , Fedex , Pfizer , Drug-administration , Johns-hopkins-university

From fatal eyedrops to mislabeled melatonin, why the FDA is failing the public

A slew of public health alarms raise concerns about what's going on at the Food and Drug Administration

India , United-states , America , Americans , John-abramson , C-michael-white , Peter-robison , Pieter-cohen , Arthur-caplan , Stephen-hahn , Pfizer , How-big-pharma-broke-american-health-care

Killing of medical research innovation -- Puppet Masters -- Sott.net

Killing of medical research innovation -- Puppet Masters -- Sott.net
sott.net - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from sott.net Daily Mail and Mail on Sunday newspapers.

United-states , United-kingdom , Edinburgh , City-of , Wuhan , Hubei , China , White-house , District-of-columbia , India , America , American

Why DeSantis would consider RFK Jr. for key public health posts

Ron DeSantis is open to naming Robert F. Kennedy Jr. to a public health role in his prospective administration. The question, of course, is why.

China , New-york , United-states , Florida , Orlando , Chinese , Joseph-ladapo , Stephen-hahn , Clay-travis , Rochelle-walensky , Ron-desantis , Robert-califf

Surprise, Surprise: Look Where Birx Just Landed a New Job

California , United-states , Deborah-birx , Megan-redshaw , Mark-mcclellan , Scott-gottlieb , Petera-mccullough , Stephen-hahn , Pfizer , Armata-pharmaceuticals , Johnson , Flagship-pioneering

Rupert Vessey, former Bristol Myers exec, to join Flagship as top scientist

BioPharma

Stephen-hahn , Bristol-myers , Rupert-vessey , Michael-severino , Bio-pharma , Noubar-afeyan , Merck-co , Bristol-myers-squibb , Drug-administration , Flagship-pioneering , Bridgebio-pharma , Drug-administration-commissioner-stephen

FDA Chief Encourages States To Open Photographs To Extra Individuals • MV TELEGRAPH

On New Year's Eve, people wait in line to get a COVID-19 vaccination at a location for seniors in an unoccupied shop in Oviedo Mall. Governor Ron DeSantis

Kentucky , United-states , Pennsylvania , Florida , Americans , Ron-desantis , Stephen-hahn , Paul-hennessy-lightrocket-getty , Nancy-messonnier , Pfizer , Alliance-for-health , Johnson