Should FDA Be Holding the Avandia Advisory Committee Meeting?

Should FDA Be Holding the Avandia Advisory Committee Meeting?

June 5th, 2013 // 1:03 pm @

Latest FDA and cGMP Compliance News

This highly controversial agency advisory committee meeting is starting today, but a question remains open – would letting up on the restrictions on the Avandia diabetes pill make a difference? The GSK drug, which has been linked to heart attack and stroke, is pretty much not available on the market. This is due to a REMS that was initiated in 2010 after a controversial FDA meeting in that same year.

The meeting today is being held to go over a GSK clinical trial known as RECORD, which supposedly refuted a meta analysis done in 2007 that found more heart risks than were known in the past. This caused there to be a probe by the US Senate into the GSK trial data, which was what contributed to a fine of more than $3 billion last year.

The RECORD trial has been criticized heavily by one FDA reviewer, but some FDA officials don’t agree with this view. They then ordered a review. The Duke Clinical Research Institute was selected to go through data and discovered that the pill was not shown to be related to a higher heart risk. FDA reviewers did not that the trial design was rather weak. The reviewer, Tom Marciniak, says that the re-adjudication was not really independent.

FDA is convening this meeting to air all findings and to go over decisions that were made. Some argue that this is a good effort at being transparent. FDA has been criticized harshly in public by a cardiologist named Steve Nissen, who was a co author on the meta analysis. He says FDA is just attempting to save face, as GSK did not disclose some data about added heart risks and shared it with agency staff. But this was not revealed and they were rather embarrassed when the meta data analysis was published.

You can read the FDA briefing docs here. They indicate that restoring Avandia to wide release is not going to happen probably. However, you can never tell with these advisory meetings. FDA is going to determine if the restrictions on Avandia should be modified, kept the same or removed. But will easing up on these restrictions change the prescription habits of doctors? Only 3000 patients are on the drug today, and Avandia has been largely discredited. What do you think?


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