FDA's Avandia problem
FDA faces Avandia decision without clear guidance from its 2nd advisory panel
FDA officials walked out of an advisory panel meeting on Avandia rosiglitazone last Wednesday evening with the same problem they came in with on Tuesday morning: how to handle a drug that has been accused but not firmly convicted of causing an increase in cardiovascular events in a population that has a very high rate of heart attacks and strokes.
The committee split into three almost equal groups that recommended mild, moderate and extreme regulatory actions: 10 members voted to keep Avandia on the market with existing or updated labeling; 10 advised adding additional limits on its use, such as restricting prescribing to certain physicians or requiring special physician or patient education; and 12 wanted FDA to compel GlaxoSmithKline plc to withdraw the drug from the U.S. market...