FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The Eu­ro­pean Med­i­cines Agency and Health Cana­da con­tin­ue to out­pace the FDA when it comes to proac­tive­ly re­leas­ing da­ta on drugs and bi­o­log­ics the agency has re­viewed, lead­ing to fur­ther ques­tions of why the Amer­i­can agency can’t be more trans­par­ent.

In a study pub­lished re­cent­ly in the Jour­nal of Law, Med­i­cine, & Ethics, Yale and oth­er aca­d­e­m­ic lawyers and re­searchers found that be­tween 2016 and April 2021, the EMA proac­tive­ly re­leased da­ta for 123 unique med­ical prod­ucts, while Health Cana­da proac­tive­ly re­leased da­ta for 73 unique med­ical prod­ucts be­tween 2019 and April 2021. What’s more, the EMA and Health Cana­da didn’t proac­tive­ly re­lease the same da­ta on the same drugs. In stark con­trast, the FDA in 2018 on­ly proac­tive­ly dis­closed da­ta sup­port­ing one drug that was ap­proved that year.

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