FDA Trails EMA, Health Canada in Proactively Releasing Drug Data, Says Study

The FDA is outperformed by the European Medicines Agency (EMA) and Health Canada when it comes to proactively releasing data on drug approvals, says a new study ― prompting concerns about the FDA’s relative transparency.

From 2016 to April 2021, the EMA proactively published supporting data on 123 drugs, while during the same period, Health Canada proactively released data for 73 drugs, said the researchers from Yale University and other academic institutions, who published their findings in the Journal of Law, Medicine & Ethics.

By comparison, from 2016 to April 2021, the FDA proactively published data on just one drug, approved in 2018, and last year ended a pilot program aimed at increased transparency of supporting drug data.

Over the past 10 years, the EMA and Health Canada have “greatly expanded the public availability of regulatory data, while the FDA has lagged behind by not proactively publishing clinical reports,” the researchers said.