Despite Progress In Data Transparency, The FDA Still Keeps Its Data Secret

Eminent scientists have succeeded in gaining access to trial data from the European and Canadian drug regulators, but a recent analysis published in the Journal of Law, Medicine, & Ethics, found that the US FDA still lags behind others when it comes to data transparency.

Drug regulators have traditionally been the guardians of a treasure trove of trial data which they kept hidden from the public.

In 2013, EMA announced that it would provide public access to regulatory data - which included study reports, protocols and the raw anonymised patient data in statistical programmes enabling anyone to independently scrutinise the data for all new drugs that it approved.

Notably, the Canadian drug regulator has gone one step further than EMA by proactively releasing data for not only approved drug submissions, but also "Unapproved, and withdrawn drug and biologic submissions Class III and IV medical device applications."

The US FDA houses the largest known repository of clinical trial data in the world, but it doesn't proactively share it.

In stark contrast, the FDA only proactively disclosed data supporting one single drug that was approved in 2018, clearly demonstrating that the agency has failed to keep pace with the European and Canadian regulatory bodies.

The problem of data secrecy within the FDA has been especially evident during the pandemic. 

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