Regulatory Focus™ > News Articles > Researchers Call on FDA to Follow EMA's Lead in Publishing Study Reports

Researchers Call on FDA to Follow EMA's Lead in Publishing Study Reports

Posted 22 February 2017 | By Michael Mezher 

Researchers Call on FDA to Follow EMA's Lead in Publishing Study Reports

Two researchers are calling on the US Food and Drug Administration (FDA) to follow the European Medicines Agency's (EMA) lead in proactively publishing clinical study reports.

In an article published in JAMA on Monday, Anna Davis and James Miller of Johns Hopkins Bloomberg School of Public Health say that FDA's position as the global leader in drug regulation "may be undermined" if it is not able to match EMA's efforts.

"The proactive publication of clinical study reports by a drug regulatory agency is unprecedented but heralds progress toward greater transparency," they write, adding that EMA "is poised to leapfrog ahead of the FDA."

Clinical Trial Transparency

Clinical trial transparency has been a major concern of public health advocates and regulators for decades. According to a recent Health Affairs report, "up to half of all clinical trials never have their results published," and clinical trials with negative results are even less likely to be published than those with positive ones.

In October, EMA kicked off its effort to proactively publish clinical study reports, referred to as Policy No. 0070, with the publication of clinical reports for two drugs, Kyprolis (carfilzomib) and Zurampic (lesinurad). Six other drugs' clinical reports have also now been published.

Under that policy the agency plans to publish clinical trials data submitted in support of a marketing authorization to an online database, whether the product is ultimately authorized, rejected or withdrawn.

However, Davis and Miller warn that the progress made by EMA could be threatened by a pending legal decision in a dispute between the agency and PTC Therapeutics over the release of clinical study reports for PTC's Duchenne muscular dystrophy (DMD) drug Translarna (ataluren).

Last year, the EU General Court issued an interim ruling blocking EMA from releasing a clinical study report for a Phase II study for Translarna that was used to support the drug's approval. EMA has contested the ruling, though a final ruling has yet to be made.

While the case does not directly involve EMA's proactive publication policy as the reports were requested by another company under EMA's access to documents policy (Policy No. 0043), Davis and Miller warn that the ruling in the case could have significant impact on Policy No. 0070.

"A decision in favor of PTC Therapeutics might mean that clinical study reports are deemed confidential commercial information as a whole and thus not subject to public release at all," Davis and Miller write.

In contrast, FDA currently treats clinical study reports as confidential commercial information, though in 2010 the agency's Transparency Task Force found that the release of clinical trial results could be beneficial, and suggested that a "blanket policy against disclosure of this type of information may not be justified."


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