We urgently need you to respond to two important consultations to defend independent analyses.
Tell the EMA not to censor independent analyses
In Europe, the medicines regulator wants the right to censor analyses of side effects data that it disagrees with. The European Medicines Agency (EMA) is consulting on updates to its EudraVigilance access policy. EudraVigilance is the database where reports of side effects from approved drugs in Europe are recorded. The proposal would give researchers access to more detailed and systematic records from the database but it also contains a condition that would give the EMA the ability to block publication of analyses it disagreed with.
Please respond to the EMA’s consultation, even with a short comment, before the deadline of Monday 15th September 2014. Feel free to use any or all of our response to write your own. To respond email EVAccess@ema.europa.eu.
Tell the FDA not to introduce barriers to data sharing
The US Food & Drug Administration (FDA) draft guidance on writing consent forms for clinical trials doesn’t say that trial sponsors can share anonymised patient data with independent researchers. Some pharmaceutical companies already claim that they can’t share more information from their clinical trials because consent forms didn’t explicitly include this.
Please respond to the FDA’s consultation, even with a short comment, before the deadline of Monday 15th September 2014. Feel free to use parts of our response to write your own. Use their comment form to respond.