Holding the FDA Accountable

Serious questions have been raised about the way the Food and Drug Administration has responded, or not, to information about cardiovascular risks associated with Avandia, a popular diabetes drug.  As part of my effort to protect the integrity of federal programs that pay for health care, I’ve pressed the FDA for a clear response.  An FDA advisory panel meeting set for mid-July is an opportunity for patients, doctors and taxpayers to get necessary attention paid to these issues. 

In February, Senator Baucus and I released a Finance Committee report that expressed concern about the steps the FDA took to protect patients amid substantial controversies surrounding Avandia, which was approved for market in the U.S. in 1999.  I will continue to monitor how the FDA handles this drug, because I think any decision that is made may shape the future culture of drug safety at the agency.

In this case and others, I’ve fought very hard to establish greater independence for the office that reviews the safety of drugs after they’re on the market.  That function ought to be separate from the office that approves drugs for the market in the first place.  The post-market surveillance office has been strengthened, but the new drugs office still carries too much sway given its inherent conflict of interest.  We’ve seen that problem in black and white with the diabetes drug Avandia. There needs to be an independent center for post-market drug safety at the FDA, a center that would work collaboratively with the approval office but have its own decision-making authority.

My legislation to strengthen the independence of the post-market surveillance office was defeated during debate over the larger FDA bill in 2007 by a single vote.  I continue to work for changes to establish independence for drug safety review at the FDA.  Americans deserve to know that this agency is working to keep them safe from harmful drugs.