10/29/2007- Last week, the Glaxo diabetes pill was in the news again because the FDA is now considering a second Black Box warning for heart attacks, in addition to an earlier warning for congestive heart failure. However, Chuck Grassley, the Republican Senator from Iowa, wrote the agency last week to learn more about something that wasn’t previously known - the FDA’s Drug Safety Oversight Board on Oct. 2, supposedly voted to keep Avandia on the market, but by a thin margin of 8 to 7.

And so Chuck has written a letter to the FDA commish Andy von Eschenbach to explain more about the voting and why there was no public disclosure. “I have yet to see any public notification of this vote,” his letter states. “Accordingly, I would appreciate information from the FDA regarding the internal policies and procedures governing the DSOB and the terms and conditions governing the release of information from the DSOB to the public.”

Beyond Avandia, the issue Grassley is raising is the extent to which the FDA will be transparent. The point he seems to be making is that, while creating a new Drug Safety Oversight Board may prove to be helpful, the deliberations and decisions should be publicized on a timely basis. Otherwise, the agency continues to labor under the impression that important actions are being determined in a secretive fashion.