Many recent FDA-approved drugs and biologics turn out not to be safe and effective and eventually are taken off the market or given new warning labels. To help ensure a drug’s effects are well understood after they come to market and protect patient safety, the FDA often requires pharmaceutical companies to perform post-marketing studies. A May 2018 study published in BMJ finds that Pharma frequently does not report postmarketing studies as required. Too often, the study results are a black hole.
Indeed, the BMJ research finds that more than one out of four required studies were not published on clinicaltrials.gov. That’s correct. The results of the postmarketing studies were not publicly available in more than one out of four instances.
Moreover, the results of clinical studies published on clinicaltrials.gov contained so little information, with an average length of 44 words, as to be unhelpful. The FDA gives pharmaceutical companies a lot of freedom to design these studies. So, the studies often do not address the issues that doctors and patients want to understand.
Between 2009 and 2012, the FDA required pharmaceutical companies to do follow-up studies of 97 out of 110 new drugs and biologics it approved, imposing 437 post-marketing requirements, including 110 clinical trials. Many study results were not reported by their deadline. Fewer than six in ten post-marketing study results were published in peer-reviewed journals.
The researchers concluded: “These findings highlight the need for more detailed postmarketing requirement study descriptions, increased FDA transparency, and clearer and more consistent registration and results reporting standards for these critical FDA required studies.”
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