Healthcare News & Insights

Senate report raises questions about FDA after-market review

A new report from the Senate Finance Committee highlights a potential conflict of interest within the FDA — and the safety of one of the world’s top-selling medications. According to the report (download), GlaxoSmithKline was aware several years ago that there was an increased risk of heart attack among users of the popular diabetes drug Avandia. The report says that Glaxo execs sought to squelch the information as far back as 1999 by complaining about researchers who said the drug was risky.

The report cites several disturbing pieces of information, including:

  • a 2007 study by researchers at The Cleveland Clinic that claimed Avandia users had a 43% higher risk of heart attacks, and
  • a 2008 FDA internal review that led two scientists to recommend Avandia being taken off the shelf.

The recommendation was ignored, although the FDA has asked for a new study to assess the true risk of cardiovascular events among Avandia users. Glaxo has also added a black label warning regarding the potential for serious cardiovascular events.

Who regulates the regulators?

The report gives more ammunition to critics who claim the FDA needs an independent body to review after-market drugs. Currently, once drugs are on the market, any further review is done by a panel which is beneath the division that approves new drugs.

It sets up an essential conflict of interest, because the same section of reviewers who first approved the drug are then asked to re-judge their earlier decisions. FDA officials say it’s the most streamlined way to handle it,  because the people most familiar with the drug are the ones who review it.

Glaxo claims that the increased cardiac risk hasn’t been conclusively proven and that it has merely tried to correct faulty information about its product. The company’s numbers report more than $1.2 billion in global sales of Avandia last year.

Does FDA need a better way to review drugs that are already on the market, or is this much ado about nothing? Weigh in in the comments.

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