A new report from the Senate Finance Committee alleges that drug company GlaxoSmithKline not only knew about a possible link between their diabetes medication Avandia and heart attacks, but also acted to keep the FDA from pulling the drug off shelves. If so, how were they able to do it?
Under the current system, the FDA’s “post-market surveillance” group, which monitors complaints and concerns about drugs after they’ve been approved for public use, reports to the division of the Administration that approves new medications. Some say this impedes the investigation into already-approved products because it implies mistakes were made in the initial testing.
In the case of Avandia, the Senate report claims that in 2008 FDA chiefs rejected research by their own scientists that determined the drug should be pulled from the market. For its part, GSK says denies interfering with any investigation into Avandia, though they do admit they tried to correct “misinformation.”
There has been talk for some time of a need for the FDA’s post-market group to exist independently from the rest of the Administration.
“It doesn’t make any sense to let these [safety reviewers] be overruled by officials who approved the drug in the first place and have a natural interest in defending their decision,” said Sen. Chuck Grassley of Iowa, the Ranking GOP Member of the Senate Finance Committee.
For now, Avandia remains on the market, though it is labeled with a warning regarding risk for cardiac incident. Though sales dipped in 2007 after the first reports of a possible link to heart attacks, Avandia brought in an estimated $1.2 billion in sales to GSK in 2009 alone.
What do you think: Is there need for an independent division of post-market review at the FDA?
Glaxo Drug Faces More Scrutiny [Wall Street Journal]