FDA Panel Votes to Ease Up Avandia Restrictions

FDA Panel Votes to Ease Up Avandia Restrictions

June 7th, 2013 // 1:25 pm @

Latest FDA and cGMP Compliance News

A very intense two day FDA advisory committee meeting showed the many challenges in determining the best path to drug safety. In the end, FDA’s panel was divided but voted to let up on restrictions on the use of Avandia, the highly controversial diabetes drug. The pill had been pretty much under regulatory lock and key for three years.

There were 26 panelists on the committee, and 20 voted to remove or to modify the REMS (Risk Evaluation Mitigation Strategy), which was first set up three years ago, after a long controversy about how much the GSK drug could cause heart problems. That debate started after a 2007 metaanalysis showed there was a 44% higher risk of stroke and heart attack with Avandia.

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Even after the vote, there is still much uncertainty. The panelists did not agree on how to loosen the REMS, which was one of many that was set up after many recent drug safety problems in recent years. The Avandia program has a med guide and another aspect called ETASU (Elements to Assure Safe Use), which tells patients the terms for doctor participation, enrollment of patients and requirements for distribution.

One panelist stated that he did think that the med guide and communication strategy should continue, but it may be possible to drop the ETASU. Marvin Konstam from Tufts University School of Medicine said that this will change the burden to doctors and allow them to use their best judgement.

Another panelist said that she thought that easing the REMS would put the drug on a more even field with other drugs with the same type of risks.

Other panelists said that another clinical tril should be done to get outcomes data on adverse side effects and events. The previous GSK clinical trial was re-adjudicated and suggested that the pill did not increase heart risks.

There are some problems to doing a new trial, such as ethical problems. The REMS restrictions are there, and after all of the negative publicity, there is a much smaller population of patients using the drug. There only are 3000 people using the drug in the US today, down from 120,000 a few years ago.

There also would be little reason for GSK to sponsor a new trial. The patent for Avandia expired in 2011. Sales were less than $10 million in 2012. The pill once generated $3 billion in sales.

Whatever FDA does is going to be watched closely, because the agency got a lot of criticism for how it handled the Avandia scandal. FDA officials knew about trial data that was not disclosed, and this became an issue for GSK and was a reason the firm had a $3 billion fine for bad corporate behavior. FDA also was accused of suppressing another Avandia clinical study.

Also, one author of the meta analysis in 2007, Steve Nissen, blased FDA for trying to save face by holding the advisory committee meeting this week. He also noted that FDA did not issue an invitation for him to speak this week at the meeting.

Even with all of this drama, the panelists this week though that the re-adjudication process was quite credible. They did agree with FDA reviewers that the RECORD trial did have several flaws though. Some said that the study did not give strong evidence that Avandia is safe.

 

 


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