Should Clinical Trial Data Be Publicly Available?

The Canadian Department of Health has recently made a decision to allow the public to access the clinical trial data that “companies submit when seeking approval for a new drug, biological treatment, or medical device.” Though drug manufacturers can negotiate possible redactions of the data with Health Canada, Health Canada retains ultimate control over what information gets redacted and what information is published in reports. Health Canada has already released data for four new drugs and soon plans to release data for thirteen other drugs and three medical devices. Health Canada’s decision to make this data public is similar to the decisions of agencies in other nations, such as the European Medicines Agency (“EMA”), which also makes such data publicly available. On the contrary, the U.S. Food and Drug Administration (“FDA”) treats clinical trial data submitted to the FDA as confidential and rarely makes it available to the public. The FDA claims that U.S. laws prevent such disclosure of data. Despite the FDA’s contention that disclosure would be against the law, legal experts argue that the FDA is entitled to substantial deference in deciding which data should be kept confidential. It will be interesting to see whether the FDA continues its current trend of keeping the data private or if it will, like Canada Health and the EMA, make this information available to the public.

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Blog post authored by Rebecca Falk

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