Regulators mull pros, cons of transparency efforts

Regulator transparency has become a rallying cry on both sides of the pond. The European Medicines Agency has been advised by the European ombudsman to reconsider a request for information that it denied two years ago. The case concerns reports of adverse reactions to an acne drug.

In denying the request, the agency had argued that regulations outlining the granting of information excluded adverse event reports. The ombudsman disagreed, stating that the intent of the regulation was to cover all agency documents. In addition, granting the request, by providing greater EMA transparency, would improve Europeans' trust in the agency. It's up to the agency now to consider the ombudsman's recommendation.

In the U.S., as we've reported, the FDA continues its voluntary march toward transparency, led by Commissioner Margaret Hamburg. The regulator is awaiting public comments on 21 draft proposals, culled from 1,500 comments gathered as part of its transparency initiative.

- read the European ombudsman's draft recommendation

Webinar

Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.