FDA leaves $10 billion in fines uncollected as thousands of clinical trials go unreported
The FDA has failed to collect over $10 billion in fines from companies and universities for violations of a key clinical trial transparency law, data released today show.
According to the latest FDAAA Trials Tracker figures, 2,050 clinical trials are currently missing results on the world’s largest trial registry, ClinicalTrials.gov, which was set up to provide a comprehensive overview of research into drugs and medical devices.
By law, the FDA has the power to fine pharmaceutical companies and universities over $11,000 per day for failing to make the results of clinical trials public on the registry. Due to widespread violations of the law, trial sponsors have now racked up $10,009,047,609 in potential fines, but the FDA has yet to collect a single cent.
Hidden clinical trial results leave large gaps in the medical evidence base. In the past, such gaps have caused thousands of patient deaths in the United States alone.
Billions of dollars’ worth of medical research funding are wasted every year because costly clinical trials – often funded with public money – do not report their results and so make no contribution to scientific progress. In addition, unreported trials drive up the cost of healthcare by causing expensive new drugs to appear more safe and effective than they actually are.
A study published yesterday highlighted how missing medical evidence undermines the response to the current pandemic.
It found that the results of over 40% of trials of potential COVID drugs are completely unknown, leaving substantial gaps in scientists’ understanding of their possible side effects. It is unclear how many of those trials are subject to legal reporting requirements, as U.S. disclosure laws only cover some clinical trials.
Despite calls by medical experts, doctors and patients to enforce the 2007 law, the FDA has so far failed to take action.
In 2016, then Vice President Joe Biden promised to cut off funding to research institutions violating the law, but that promise was not kept. The current administration also seems to be ignoring the issue, even though collecting the outstanding fines could cover the entire FDA’s annual budget. A recent court decision reaffirmed the obligation to report trial results under the law, the Food and Drug Administration Act (FDAAA).
Over 30% of trials subject to the FDA Amendments Act are currently missing results.
Some of the world’s largest pharmaceutical companies have improved their trial reporting performance in recent years, and now fully comply with the law. However, several of America’s largest trial sponsors continue to disappoint.
For example, the University of Chicago has failed to report the results of 12 out of its 32 due trials, and 21 of 30 trials run by the University of Virginia are missing results.
Cutera, a company headquartered in California, has not reported the results of a single of its 14 due trials. The FDA could have collected over $48 million from Cutera alone for its violations of the law.
TranspariMED has contacted Cutera requesting a comment and will update this blog with their response.
Image source: FDAAA Trials Tracker, EBM Data Lab, University of Oxford
Till Bruckner, founder of TranspariMED, said:
“Neglecting to make clinical trial results public is not a victimless crime. Hidden medical evidence harms patients, undermines public health, and contributes to exploding healthcare costs. The direct and indirect costs of this rampant research waste in medicine are staggering. In the midst of a pandemic, public health agencies and clinicians should not have to make decisions based on incomplete medical evidence.”
“Over a decade after Congress passed the FDA Amendments Act with overwhelming bipartisan support, the Food and Drug Administration still refuses to enforce this common-sensical law."
"It is high time for policy makers in Washington to wake up to this blatant disregard of Congressional intent by the FDA, and demand that the agency finally put an end to impunity in medical research involving human participants.”
Rachel Cooper, Director of the Transparency International Health Initiative, said:
"As the world's scientists race to develop effective treatments, vaccines and technologies against Covid, it is crucial that all trials are reported and that taxpayers (who often pay for the trials) get value for money. It is scandalous that governments and regulators continue to turn a blind eye to non-reporting of trial results."
Merith Basey, Executive Director of Universities Allied for Essential Medicines North America, said:
"It is already required by US law that these particular clinical trials are registered and reported. Why is action still not being taken by the FDA to hold universities accountable? We urge universities to comply with the law and improve health outcomes by reducing waste in research, increasing efficiency and limiting reporting bias. It's high time the FDA did the same."
Tracey Brown, Director of Sense about Science, which houses the AllTrials campaign, said:
“It’s extremely disappointing to see how much of the COVID research, tracking and monitoring could have been funded - and could still be funded - by fining the lax clinical trial rule breakers who waste medical research funds and patient time by failing to report their results.”
Globally, around half of all clinical trials never make their results public. Denmark recently became the first country worldwide to impose sanctions on trial sponsors that violate transparency rules.
In theory, reporting the results of drug trials is already obligatory in Europe, but this obligation will only become a formal legal requirement in all European Union member states next year.