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Regulatory Focus – FDA Transparency: Gottlieb Outlines What’s Coming

Regulatory Focus – FDA Transparency: Gottlieb Outlines What’s Coming

FDA Commissioner Scott Gottlieb has been at the forefront of the Washington, D.C. conference circuit this week discussing new work that the agency he leads will undertake, with discussions Thursday at a Politico event, a speech Wednesday at the Friends of Cancer Research, a speech Monday at RAPS’ Convergence and a speech last week at the National Health Research Forum.


On Thursday, Gottlieb highlighted a few upcoming moves that the agency plans to make in terms of transparency.


An announcement is coming “soon” on a new web-based system that will allow easier access to adverse event data for clinicians. Gottlieb said the tool would more easily allow queries to the database of adverse events to be made.


In addition, Gottlieb said the agency will soon begin releasing letters that FDA sends to brand drug companies when generics question the agency on whether they should be able to obtain samples of the brand drugs necessary to produce generic versions.


The transparency effort is part of work the agency is doing to stop branded drug companies from misusing Risk Evaluation and Mitigation Strategies (REMS) to withhold access to drug samples for bioequivalence testing necessary for bringing generic drugs to market.


And the elephant in the room on transparency – releasing redacted Complete Response Letters – was also mentioned again by Gottlieb (he previously said he backed the idea), though no definite timeline has been set for their release, which would probably require a change in regulations.…