The U.S. Food and Drug Administration is coming under increasing pressure to finally enforce a 2007 law requiring clinical trial results to be made public.
Only weeks after a senior Congressman wrote to the FDA urging enforcement, activists with Universities Allied for Essential Medicines (UAEM) filed a formal citizen petition, triggering an obligation by the FDA to respond to within 180 days.
The petition asks the FDA to:
Significantly step up its enforcement efforts
Prioritise the most important trials for enforcement
Publicly list enforcement letters that have been sent
How bad is the problem?
Thousands of clinical trial results are currently missing from the public ClinicalTrials.gov database due to the FDA’s failure to enforce the law, and U.S. taxpayers have missed out on over $43 billion that the FDA could have collected in fines since 2017 alone.
Only recently, a report identified dozens of clinical trials involving thousands of American children whose results had never been made public in any form, while an academic study found that unreported trials were wasting over $100 million in taxpayers’ money disbursed by the National Institutes of Health every single year.
Navya Dasari, lead of UAEM’s Clinical Trial Transparency Campaign, said:
“We filed this petition because we want the FDA to enforce the law more, to do so in a way that makes sense from a public health perspective, and to increase transparency and public accountability regarding the agency's enforcement decisions.”
UAEM's petition runs to 30 pages and is worth reading in full – it lays out the legal and medical rationale for enforcement, documents FDA’s lacklustre enforcement efforts to date, and cites multiple examples of harms to patients and misspending of public money caused by hidden clinical trial results.
FDA boss admits there is a problem
FDA Commissioner Robert Califf himself has admitted that:
“Out-of-date, incomplete, or inaccurate trial information can distort understanding of the evidence base and the research landscape. The [ClinicalTrials.gov] database is not only an information resource for individual clinical trials, but also essential for identifying all trials studying particular research questions.”
“For example, without ClinicalTrials.gov, there would be no way to know how many COVID-19 trials had been initiated, what drugs or other interventions were being evaluated, when the trials would be completed, and, ultimately, what the trials found.”
How should FDA enforce the law?
The petition notes that “Congress clearly intended for FDA, along with NIH, to monitor and enforce the compliance of every single applicable clinical trial.”
However, assuming that FDA lacks the resources to follow up on every single violation, UAEM suggests that the agency should “make NIH-funded trials of FDA-approved products its highest priority for enforcement”.
The petition was drafted with assistance from Columbia Law School’s Science, Health and Information Clinic. According to student attorney Davis Gonsalves-DeDobbelaere, effective enforcement of the law “could bring in an enormous stream of revenue currently being filled by taxpayer dollars.”
You can support UAEM’s petition
Please support UAEM’s petition by submitting a comment here.
Before you do so, please contact UAEM to discuss.
Both individuals and organisations can comment. For an example of what your comment might look like, see this comment by TranspariMED’s partner Consilium Scientific. TranspariMED itself submitted a comment today.