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Tracking FDAAA Noncompliance: AllTrials Calls on FDA to Levy Fines

Posted 19 February 2018 | By Zachary Brennan 

Tracking FDAAA Noncompliance: AllTrials Calls on FDA to Levy Fines

The international initiative AllTrials on Monday unveiled a new tracking tool to highlight clinical trial sponsors who fail to publish results as required by the FDA Amendments Act of 2007 (FDAAA).

In an open letter to US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, urging the agency to crack down on such sponsors, AllTrials founders Ben Goldacre and Síle Lane explained how FDA has the power to “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.”

The letter notes that relevant trials have 13 months from completion to post summary results and adverse event information, and that 17 February is 13 months since a final rule on FDAAA took effect.

AllTrials’ FDAAA noncompliance tracking tool also went live at FDAAA.TrialsTracker.net on Monday, using data from ClinicalTrials.gov to flag sponsors that are not compliant.

“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,” the letter said.

But it remains unclear what impact the tracker and attention to FDAAA compliance might have on FDA.

In September 2017, following a New England Journal of Medicine article highlighting FDAAA noncompliance, FDA officials said the authors' analysis painted an inaccurate picture of the postmarket study landscape as it lumped postmarket requirements with postmarket commitments and did not take into account justifiable delays.

By their count, the FDA officials say 88% of postmarketing requirements in general, and 89% of FDAAA postmarketing requirements were progressing on schedule as of 2015.

"An accurate analysis of the effect of the FDAAA would evaluate the timeliness of FDAAA postmarketing requirements separately from that of other postmarketing requirements and commitments," FDA officials wrote.

And while the agency has not fined any sponsors, FDA has warned firms for failing to meet postmarketing requirements.

"FDA actively monitors and takes appropriate action when an applicant (drug firm) is noncompliant with a requirement to conduct a postmarket safety study or clinical trials under section 505(o)(3) of the Food, Drug and Cosmetic Act, and fails to demonstrate good cause for its noncompliance … it is FDA's practice to give firms an opportunity to take voluntary and prompt corrective action before the agency initiates an enforcement action, including issuing civil monetary penalties," an agency spokesman said.

FDAAA TrialsTracker: A live informatics tool to monitor compliance with FDA requirements to report clinical trial results

Open Letter to FDA

Categories: Regulatory News

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