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Sharing the Clinical Data

Health Canada is beginning to make information that drug companies provide when seeking regulatory approval available to the public, Undark reports. It notes that while the European Medicines Agency has a similar policy, the US Food and Drug Administration does not and it keeps that information confidential.

So far, Health Canada has released reports on four drugs that it recently approved and plans to release reports for an additional 13 drugs and three medical devices that it either approved or rejected since March, Undark says. It adds that transparency advocates say this will enable researchers to sift through the data and uncover aspects that regulators may have overlooked that might inform how a drug should be used. They also say that some of the data in these reports is also not always included in medical journal articles.

Transparency advocates have urged the US FDA to follow the Canadian and European examples, Undark adds. But an FDA spokesperson from tells it that it is bound by different trade secret and privacy laws than Canadian and European regulators are and is limited in what it can share.