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FDA excuses failure to enforce key transparency law: 'It's too complex'

A Citizen Petition challenging the U.S. Food and Drug Administration to take action over thousands of missing clinical trial results has been cast into administrative limbo by the FDA.


In February, student advocacy group Universities Allied for Essential Medicines (UAEM) had formally petitioned the FDA to finally start enforcing a 2007 law requiring certain clinical trial results to be made public. At present, over 4,000 clinical trial results are missing in violation of the law, leaving evidence gaps that endanger patient safety.


Instead of responding to the petition, the FDA now says that it needs more time to think things through:


“FDA will require additional time to issue its final response to your petition because of the complexity of issues raised. FDA intends to respond to your citizen petition once our review is complete… We will respond to your petition as soon as we have reached a decision on your requests.”


By law, the FDA could impose a fine of $13,000 for each day a trial result is not reported.


To date, the FDA has not imposed a single fine.


Megan Curtin, UAEM’s Clinical Trial Transparency campaign lead, said:


“The response from the FDA is disappointing. We asked for the agency to prioritize clinical trial transparency for the sake of patient health and safety, and the agency has chosen to further delay enforcement of the law."


Till Bruckner, founder of TranspariMED, said:


“Powerful companies and institutions have been thumbing their noses at the law for many years, and the FDA has still not imposed a single fine. End of story. There’s no ‘complexity’ whatsoever here.”


According to a UAEM press release:


“Over the past 16 years, the FDA has consistently failed to meet their federal obligations outlined in the FDA Amendments Act (FDAAA of 2007). Congress holds the FDA responsible for ensuring clinical trial sponsors report results within a set timeframe to ClinicalTrials.gov.”


“These clinical trial results are essential to ensure drug efficacy and patient safety. By failing to enforce the law, the FDA has lost over $46 billion in uncollected fines as a result of overdue results reporting."


"The FDA’s delayed response to UAEM’s citizen petition is an indication that the agency still is not prioritizing this oversight.”


The petition requested three specific actions from the FDA:

1. Increase enforcement and impose fines when appropriate

2. Explains how it will focus its enforcement efforts

3. Create a public dashboard of enforcement measures


The FDA did not announce a date by when it will finally respond to the petition.


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