Dr Scott Gottlieb
Food and Drug Administration
16th February 2018
Dear Dr Gottlieb
As the body responsible for compliance with the FDA Amendments Act 2007, you have the power to sanction those who break this law, including the levy of fines up to $10,000 a day against clinical trial sponsors who fail to publish their trial results on ClinicalTrials.gov. There are, though, trials on that register whose results are years overdue, and to date you have not issued a single fine. Since 2014, AllTrials has been asking the FDA to censure these sponsors. The FDA has assured us, publicly and privately, that new clarifying rules – the FDAAA Final Rule – will help you do so. Relevant trials have 13 months from completion (12 + 1 for quality check) to post summary results and adverse event information. Tomorrow, February 17th, it is 13 months since the FDAAA Final Rule. To avoid further delay in identifying missing trial results, from Monday our new tracking tool will start publicly flagging sponsors and trials that breach their reporting deadline.
The tracking tool will be live online at FDAAA.TrialsTracker.net and will begin showing data from Monday February 19th. Using ClinicalTrials.gov’s data, it identifies trials that are subject to FDAAA 2007 as they reach 13 months from completion date and flags missing results. As the list grows each week, the website will show a ranking of the sponsors with the most trials that appear in the data to be in breach of the law. It will also display an estimate of the total amount in fines that the FDA could levy in response to these breaches.
Trials on ClinicalTrials.gov involve hundreds of thousands of patients, and treatments that are in use all over the world. Doctors and patients need the results of these trials to make decisions, and they form the benchmark for licensing new medicines. That is why AllTrials has become a global campaign of 1000 patient groups, medical bodies and research sponsors, committed to getting all trial results published.
We know that the FDA takes patient safety seriously and we are sure that you will follow the tracker to act on unreported trials. However, to assist you further we will also write weekly with the list of trials that have breached their reporting requirements and a rolling total of the fines that these should incur.
Ben Goldacre & Síle Lane, www.alltrials.net
Update 26 February 2018
Read our first follow up letter to the FDA with the trials in breach after one week of the FDAAA tracker being live. Fines are already over $1m.
Update 5 March 2018
We’re continuing to write to the FDA with trials in breach and the potential fines have already reached over $4.7m.